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1
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Makarova E, Goleva O, Gabrusskaya T, Ulanova N, Volkova N, Shilova E, Tolkmit M, Revnova M, Kharit S, Kostik M. Anti-vaccine antibodies against measles, rubella, parotitis and hepatitis B in children with inflammatory bowel disease and healthy controls. World J Clin Pediatr 2025; 14:104704. [DOI: 10.5409/wjcp.v14.i3.104704] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2024] [Revised: 03/09/2025] [Accepted: 03/13/2025] [Indexed: 06/16/2025] Open
Abstract
BACKGROUND Patients with inflammatory bowel diseases (IBD) often miss the scheduled vaccines and have a higher risk of infection susceptibility, including vaccine-prevented diseases.
AIM To evaluate the vaccine coverage and levels of the post-vaccine antibodies against measles, mumps, rubella, and hepatitis B in children with IBD.
METHODS Total 98 patients: 46 females (47.2%) and 52 males (52.8%) with IBD (Crohn’s disease-75% and ulcerative colitis-25%) with disease onset age-11.0 (6.0; 14.0) years whom clinical data, vaccination status and levels of the post-vaccination antibodies (IgG) for measles, rubella, mumps, hepatitis B, measured with ELISA were prospectively evaluated. The control group consisted of 88 healthy peers from the biobank data.
RESULTS Patients with IBD had lower levels of measles, rubella, and hepatitis B, except mumps, compared to controls. Incomplete vaccination/non-protective titer of the antibodies against measles, mumps rubella, and hepatitis B had 33 (33.7%)/52.3%, 21 (21.4%)/50.4%, 26 (25.8)/25.6% and 26 (25.8%)/55.2%, respectively. Patients with incomplete vaccination had a lower age at the diagnosis for all vaccines. The age of the IBD diagnosis ≤ 6 years was the predictor of incomplete vaccination for measles [odds ratio (OR) = 4.6, P = 0.001], mumps (OR = 5.0, P = 0.001), rubella (OR = 5.4, P = 0.0005) and hepatitis B (OR = 5.4, P = 0.0005) and corticosteroid treatment for measles (OR = 2.2, P = 0.074) and mumps (OR = 3.0, P = 0.047) vaccines. Incomplete vaccination was the predictor of non-protective titer of antibodies against rubella (OR = 6.8, 95%CI: 2.3-19.9, P = 0.0002)/mumps (OR = 7.0, 95%CI: 2.4-20.8; P = 0.0002).
CONCLUSION Patients with IBD had low vaccine coverage and lower levels of anti-vaccine antibodies against measles, rubella, and hepatitis B. Nearly half of the IBD patients require revaccination.
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Affiliation(s)
- Elizaveta Makarova
- Department of Polyclinic Pediatrics, Saint-Petersburg State Pediatric Medical University, Saint-Petersburg 194100, Russia
| | - Olga Goleva
- Department of Experimental Medical Virology, Molecular Genetics and Biobanking, Federal Research and Clinical Center for Infectious Diseases, Saint Petersburg 197022, Russia
| | - Tatiana Gabrusskaya
- Department of Children's Diseases Named After Professor I. M. Vorontsov, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Natalia Ulanova
- Department of Gastroenterology, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Natalia Volkova
- Department of Gastroenterology, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Elena Shilova
- Department of Gastroenterology, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Maria Tolkmit
- Medical School, Pediatric Faculty, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Maria Revnova
- Department of Polyclinic Pediatrics, Saint-Petersburg State Pediatric Medical University, Saint-Petersburg 194100, Russia
| | - Susanna Kharit
- Research Department of Vaccine Prevention and Post-Vaccination Pathology, Federal Research and Clinical Center for Infectious Diseases, Saint Petersburg 197022, Russia
- Department of Infectious Diseases in Children, Faculty of Postgraduate Studies, Saint-Petersburg State Pediatric Medical University, Saint Petersburg 194100, Russia
| | - Mikhail Kostik
- Hospital Pediatry, Saint-Petersburg State Pediatric Medical University, Saint-Petersburg 194100, Russia
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2
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Dutt K, Vasudevan A, Hodge A, Nguyen TL, Srinivasan AR. Cardiometabolic diseases in patients with inflammatory bowel disease: An evidence-based review. World J Gastroenterol 2025; 31:107661. [DOI: 10.3748/wjg.v31.i24.107661] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/27/2025] [Revised: 04/26/2025] [Accepted: 06/09/2025] [Indexed: 06/26/2025] Open
Abstract
Metabolic syndrome-comprising central adiposity, dyslipidaemia, insulin resistance, and hypertension-is a major risk factor for cardiometabolic diseases such as ischaemic heart disease, stroke, and type 2 diabetes. Its global prevalence is rising, largely driven by urbanization, sedentary lifestyles, and dietary changes. These same factors are also associated with the increasing incidence of inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis. Emerging evidence supports a potential biological link between chronic gastrointestinal inflammation and the later development of cardiometabolic disorders; a connection that is particularly relevant for patients with IBD. Comparative studies examining cardiometabolic risk associated with Crohn’s disease versus ulcerative colitis have reported inconsistent findings, likely due to confounding factors such as age, lifestyle, and comorbidities. This review summarizes current evidence linking IBD and cardiometabolic disorders, and highlights the need for clinicians to recognize cardiometabolic risk in patients with IBD. Future research should investigate whether treat-to-target strategies focused on controlling intestinal inflammation can simultaneously improve both long-term IBD and cardiometabolic outcomes.
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Affiliation(s)
- Krishneel Dutt
- Department of Gastroenterology and Hepatology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
| | - Abhinav Vasudevan
- Department of Gastroenterology and Hepatology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
| | - Alexander Hodge
- Department of Gastroenterology and Hepatology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
- School of Biomedical Sciences, RMIT, Melbourne 3000, Victoria, Australia
| | - Tuan L Nguyen
- Department of Cardiology, Liverpool Hospital, Liverpool 2170, New South Wales, Australia
- Department of Cardiology, Campbelltown Hospital, Campbelltown 2560, New South Wales, Australia
- Department of Medicine, University of New South Wales, Sydney 2033, New South Wales, Australia
| | - Ashish R Srinivasan
- Department of Gastroenterology and Hepatology, Eastern Health, Box Hill 3128, Victoria, Australia
- Eastern Health Clinical School, Monash University, Box Hill 3128, Victoria, Australia
- Department of Medicine, Austin Academic Centre, The University of Melbourne, Heidelberg 3083, Victoria, Australia
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3
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Tukek NB, Bakkaloglu OK, Sen G, Hatemi İ, Celik AF, Erzin YZ. The effects of biologics on ulcerative colitis-related colectomy rate: results of a 22-year study. Scand J Gastroenterol 2025; 60:548-557. [PMID: 40302309 DOI: 10.1080/00365521.2025.2497954] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/02/2025] [Revised: 02/25/2025] [Accepted: 04/22/2025] [Indexed: 05/02/2025]
Abstract
BACKGROUND To assess the impact of the biological era on colectomy rates in ulcerative colitis (UC) patients and identify factors associated with the necessity for colectomy in a large cohort from Eastern Europe. METHODS A retrospective cohort study was conducted on UC patients followed at a tertiary care center covering 1999 to 2021. Patients who underwent colectomy due to disease activity were compared to those who did not. Factors related to colectomy and the influence of the biological era were analyzed. RESULTS Among 1197 patients with a median follow-up of 3.3 years, 18% received biological agents and 5.3% underwent colectomy due to disease activity. The colectomy rate was lower in the biological era compared to the pre-biological era (2% vs. 12%; p < 0.001). Independent predictors of colectomy included steroid dependency, steroid resistance, lack of mucosal remission, and elevated CRP levels. Patients who achieved and maintained mucosal remission and had CRP levels below 3 mg/L had a significantly lower risk of colectomy. CONCLUSIONS The biological era has significantly reduced colectomy rates in UC patients. Achieving mucosal remission and maintaining low CRP levels are essential for preventing colectomy and improving long-term outcomes.
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Affiliation(s)
- Nur Beyza Tukek
- Clinic of Internal Medicine, Tekirdag Dr Ismail Fehmi Cumalioglu City Hospital, Tekirdag, Turkey
| | - Oguz Kagan Bakkaloglu
- Division of Gastroenterology, Department of Internal Medicine, Kosuyolu High Specialization Research and Education Hospital, Istanbul, Turkey
| | - Gozde Sen
- Clinic of Internal Medicine, Istanbul Bahcelievler State Hospital, Istanbul, Turkey
| | - İbrahim Hatemi
- Division of Gastroenterology, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Aykut Ferhat Celik
- Division of Gastroenterology, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
| | - Yusuf Ziya Erzin
- Division of Gastroenterology, Department of Internal Medicine, Cerrahpasa Medical Faculty, Istanbul University, Cerrahpasa, Istanbul, Turkey
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Gianfrancesco M, Awofeso A, Branquinho D, Guo X, McDonnell A, Jacobs W, Regueiro M. A narrative literature review of the incidence and prevalence of safety outcomes in patients with ulcerative colitis. Expert Rev Gastroenterol Hepatol 2025; 19:639-656. [PMID: 40331585 DOI: 10.1080/17474124.2025.2501224] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2024] [Revised: 04/06/2025] [Accepted: 04/29/2025] [Indexed: 05/08/2025]
Abstract
INTRODUCTION Information on rates of safety outcomes in patients with ulcerative colitis [UC] is helpful to better understand the benefit-risk profile of more recent therapies approved for UC. AREAS COVERED This narrative review provides an updated examination of the incidence and prevalence of safety outcomes in the UC patient population. Incidence and prevalence estimates were determined for outcomes including cardiac conduction disorders, infections, and malignancies from published literature [2013-2023]. EXPERT OPINION While information for certain outcomes was more frequently recorded, such as herpes viral infection (incidence rate [IR] 0.0-4.47 per 100 person-years [PY]) and malignancies [all; IR 0.0-1.77 per 100 PY], rarer outcome estimates such as bradycardia [IR 0.2 per 100 PY] and macular edema [IR 0.2 per 100 PY] were limited. Our knowledge of certain, uncommon safety outcomes and concomitant medical conditions in the UC population remains limited given the lack of data available. Even though larger cohorts with longer follow-up are warranted, estimates provided in this review will contribute to an improved understanding of the safety profile of UC therapies.
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Affiliation(s)
| | - Abiola Awofeso
- School of Community Health & Policy, Morgan State University, Baltimore, MD, USA
| | | | | | | | | | - Miguel Regueiro
- Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, OH, USA
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5
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Hisamatsu T, Kobayashi T, Motoya S, Fujii T, Kunisaki R, Shibuya T, Matsuura M, Hiraoka S, Takeuchi K, Yasuda H, Yokoyama K, Takatsu N, Maemoto A, Tahara T, Tominaga K, Shimada M, Kuno N, Fernandez JL, Hirose L, Ishiguro K, Cavaliere M, Hibi T. Real-World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study. J Gastroenterol Hepatol 2025. [PMID: 40370285 DOI: 10.1111/jgh.16936] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Revised: 01/31/2025] [Accepted: 03/01/2025] [Indexed: 05/16/2025]
Abstract
BACKGROUND AND AIM Vedolizumab (VDZ) is often used in older patients with ulcerative colitis (UC) in clinical practice; however, real-world evidence is still limited, including in those with late-onset UC. METHODS This post hoc analysis of a multicenter, retrospective, observational chart review, enrolling 370 patients with UC receiving VDZ between December 2018 and February 2020, compared effectiveness and safety of VDZ among patients ≥ 70 (n = 40) versus < 70 years (n = 330), and among patients ≥ 70 years with and without late-onset UC (age at disease onset: ≥ 70 [n = 13] versus < 70 years [n = 26]). RESULTS There were no differences between patients ≥ 70 and < 70 years in clinical remission rates (week 6: 57.5% vs. 47.6%, p = 0.9174; week 14: 62.5% vs. 54.8%, p = 0.1317; week 54: 47.5% vs. 46.4%, p = 0.8149), primary nonresponse (10.0% vs. 15.5%, p = 0.6248), loss of response (12.5% vs. 9.4%, p = 0.5675), or overall safety. Among patients ≥ 70 years, the incidence of adverse drug reactions was numerically greater in those with concomitant corticosteroids than in those without. For older patients with and without late-onset UC, week 54 remission rates were 23.1% versus 57.7% (p = 0.0544); surgery was reported in 3/13 versus 2/26 patients and hospitalization in 5/13 versus 6/26 patients. One death was reported in patients with late-onset UC. CONCLUSIONS VDZ effectiveness and safety were similar in patients ≥ 70 and < 70 years; VDZ may be a suitable treatment option for patients ≥ 70 years with UC. Patients with late-onset UC tended to have more frequent surgery/hospitalization and lower effectiveness than those without, possibly necessitating greater caution when using VDZ. TRIAL REGISTRATION Japanese Registry of Clinical Trials registration number: jRCT-1080225363.
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Affiliation(s)
- Tadakazu Hisamatsu
- Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan
| | - Taku Kobayashi
- Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
| | - Satoshi Motoya
- Inflammatory Bowel Disease Center, Sapporo-Kosei General Hospital, Sapporo, Japan
| | - Toshimitsu Fujii
- Department of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan
| | - Reiko Kunisaki
- Inflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan
| | - Tomoyoshi Shibuya
- Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
| | - Minoru Matsuura
- Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan
| | - Sakiko Hiraoka
- Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama, Japan
| | - Ken Takeuchi
- Department of Gastroenterology and Hepatology, IBD Center, Tsujinaka Hospital Kashiwanoha, Kashiwa, Chiba, Japan
| | - Hiroshi Yasuda
- Department of Gastroenterology, St. Marianna University School of Medicine, Kawasaki, Japan
| | - Kaoru Yokoyama
- Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan
| | - Noritaka Takatsu
- Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, Japan
| | - Atsuo Maemoto
- Inflammatory Bowel Disease Center, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
| | - Toshiyuki Tahara
- Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan
| | - Keiichi Tominaga
- Department of Gastroenterology, Dokkyo Medical University, Mibu, Tochigi, Japan
| | - Masaaki Shimada
- Department of Gastroenterology, NHO Nagoya Medical Center, Nagoya, Japan
| | - Nobuaki Kuno
- Department of Gastroenterology and Medicine, Fukuoka University Hospital, Fukuoka, Japan
| | | | - Lisa Hirose
- Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Kaori Ishiguro
- Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Mary Cavaliere
- Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Toshifumi Hibi
- Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
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6
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Menghini P, Buttó LF, Gomez-Nguyen A, Aladyshkina N, Buela KA, Osme A, Chan R, Wargo HL, De Santis S, Bamias G, Pizarro T, Cominelli F. Tumor Necrosis Factor-Like Ligand 1A/Death Receptor 3 Signaling Regulates the Generation of Pathogenic T Helper 9 Cells in Experimental Crohn's Disease. Gastroenterology 2025:S0016-5085(25)00606-7. [PMID: 40204100 DOI: 10.1053/j.gastro.2025.03.035] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Revised: 02/13/2025] [Accepted: 03/03/2025] [Indexed: 04/11/2025]
Abstract
BACKGROUND & AIMS Death receptor 3 (DR3) and its ligand, tumor necrosis factor-like ligand 1A (TL1A), regulate the balance between effector and regulatory T cells in inflammatory bowel disease (IBD). Although interleukin 9 (IL9)-secreting T helper 9 (Th9) cells are linked to ulcerative colitis, their role in Crohn's disease (CD) is unclear. We investigated the role of DR3 signaling in Th9 cell differentiation in mouse models of CD-like ileitis and colitis. METHODS Polarized Th9 cells with functional DR3 and DR3-deficient Th9 cells from SAMP wild-type (Th9WT) and DR3-/-×SAMP knockout (Th9KO) mice, respectively, were characterized and adoptively transferred into Rag2-/- and SAMP×Rag2-/- recipients. Expression of Th9-associated molecules from experimental mice and IBD patients/controls was compared. RESULTS Th9WT possess a proinflammatory profile compared with Th9KO cells; conversely, ablation of DR3 signaling generates anti-inflammatory responses, as reflected by increased IL10-producing cells in DR3-/-×SAMP mice. RNA sequencing and phosphoproteomic analyses show that inflammatory pathways are robustly activated in Th9WT compared with Th9KO cells, whereas Th9 cells are detected in SAMP mice in vivo, and Th9-related genes display the same expression patterns in both experimental ileitis and IBD patients. Finally, in the T-cell adoptive transfer model, Th9KO cells are less colitogenic than Th9WT, whereas IL9 blockade diminishes the severity of intestinal inflammation, indicating a crucial role of functional DR3 receptor in the pathogenicity of Th9 cells. CONCLUSIONS We demonstrate that the functional DR3 receptor is essential for Th9 cell pathogenicity, revealing a new mechanism by which TL1A/DR3 signaling drives experimental CD-like ileitis. The TL1A/DR3/Th9 proinflammatory pathway may offer a novel therapeutic target for patients with CD.
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Affiliation(s)
- Paola Menghini
- Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Ludovica F Buttó
- Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Adrian Gomez-Nguyen
- Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Natalia Aladyshkina
- Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Kristine-Ann Buela
- Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Abdullah Osme
- Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Ricky Chan
- Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio
| | - Hannah L Wargo
- Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Stefania De Santis
- Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Giorgos Bamias
- Gastrointestinal Unit, Third Academic Department of Internal Medicine, National and Kapodistrian University of Athens, Sotiria Hospital, Athens, Greece
| | - Theresa Pizarro
- Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio
| | - Fabio Cominelli
- Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Digestive Health Research Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio.
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7
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Kim DH, Kang SB. Herpes zoster infection in patients with inflammatory bowel disease. Korean J Intern Med 2025; 40:347-356. [PMID: 40360218 PMCID: PMC12081114 DOI: 10.3904/kjim.2024.342] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2024] [Revised: 10/25/2024] [Accepted: 12/17/2024] [Indexed: 05/15/2025] Open
Abstract
Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ), particularly those receiving immunosuppressive treatments such as corticosteroids, thiopurines, and biologics, which elevate the likelihood of varicella-zoster virus reactivation. Despite this, vaccination rates among patients with IBD remain low. Shingrix, a recombinant zoster vaccine, is generally preferred because of its high efficacy (> 90%) and safety profile in immunocompromised individuals, unlike the live attenuated zoster vaccine (Zostavax). This review underscores the importance of HZ vaccination for patients aged ≥ 50 years, as well as for younger patients receiving high-risk therapies such as JAK inhibitors. Tailored vaccination strategies based on individual risk factors, including disease severity, medication use, and ethnicity, may enhance prevention. Given the higher incidence of HZ in certain populations, such as those in Korea, vaccination recommendations should be adapted accordingly. Further research is needed to evaluate the long-term effectiveness of Shingrix in younger patients with IBD to ensure sustained protection and prevent complications, such as postherpetic neuralgia.
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Affiliation(s)
- Dong Hyun Kim
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju,
Korea
| | - Sang-Bum Kang
- Department of Internal Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon,
Korea
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8
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Chen M, Gao X, Cao Q, Rossiter G, Kitagawa T, Sun Y, Yang L. Efficacy and safety of intravenous vedolizumab treatment in Chinese patients with moderate-to-severe Crohn's disease. Clin Res Hepatol Gastroenterol 2025; 49:102591. [PMID: 40228712 DOI: 10.1016/j.clinre.2025.102591] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2024] [Revised: 03/24/2025] [Accepted: 03/31/2025] [Indexed: 04/16/2025]
Abstract
BACKGROUND & AIMS Vedolizumab is a gut-selective monoclonal anti-α4β7 integrin antibody treatment for Crohn's disease (CD). A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial (NCT03234907) assessed vedolizumab efficacy and safety in Chinese patients with moderate-to-severe CD and inadequate/loss of response/intolerance to previous conventional or anti-tumor necrosis factor-α therapy. METHODS Eligible patients aged ≥18 to ≤80 years with moderate-to-severe CD (CD Activity Index [CDAI] total score 220-400) were randomized 2:1 to vedolizumab 300 mg intravenous infusion or placebo at Weeks 0, 2, 6 of induction, and every 4/8 weeks during Week 14-58 maintenance treatment. Primary and secondary endpoints at Week 10 were enhanced clinical response (≥100-point decrease from baseline CDAI score), and clinical remission (CDAI score ≤150), respectively. Additional Week 10 and/or Week 60 assessments included endoscopic and biomarker (C-reactive protein and fecal calprotectin) measurements. RESULTS The study was conducted at 30 centers (August 2017 through August 2020). Enrolled patients (n = 215) were randomized to vedolizumab (n = 144) or placebo (n = 71). By Week 10, 19.4 % vedolizumab-treated versus 24.3 % placebo-treated patients achieved an enhanced clinical response. The Cui-Hung-Wang-adjusted p-value for the primary endpoint was 0.347. After maintenance treatment at Week 60, rates of enhanced clinical response, clinical remission, endoscopic response, mucosal healing, and biomarker improvements appeared greater for vedolizumab-treated than placebo-treated patients. CONCLUSIONS There were no new safety findings for vedolizumab treatment of Chinese patients with CD. Although the primary endpoint was not met, vedolizumab-treated patients showed improvements in other disease activity measures at Weeks 10 and 60.
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Affiliation(s)
- Minhu Chen
- The First Affiliated Hospital, Sun Yat-sen University, Guangdong, PR China
| | - Xiang Gao
- The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong, PR China
| | - Qian Cao
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang, PR China
| | | | | | - Yue Sun
- Takeda APAC Biopharmaceutical Research and Development Company Limited, Beijing, PR China
| | - Lili Yang
- Takeda Development Center Americas Inc., Cambridge, MA, USA
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9
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Zheng Y, Gao XJ, Huang JJ, Chen XM, Liao Y, Liu JM, Zheng YL, Zhao YY, Ding RL, Li XM, Bu J, Shen EX. The safety assessment of ustekinumab on psoriasis and psoriatic arthritis: A real-world analysis based on the FDA adverse event reporting system database. Int Immunopharmacol 2025; 151:114339. [PMID: 39987634 DOI: 10.1016/j.intimp.2025.114339] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2024] [Revised: 02/17/2025] [Accepted: 02/17/2025] [Indexed: 02/25/2025]
Abstract
OBJECTIVE To assess safety of ustekinumab (UST) on treatment of patients with psoriasis and psoriatic arthritis (PsA) by analyze UST related adverse drug events (ADEs). METHODS Data on ADEs associated with UST on psoriasis and PsA were collected from the fourth quarter of 2009 through the third quarter of 2024 in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FEARS) database. A variety of signal quantization techniques such as reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS) are used for analysis. RESULTS A total of 67,765 ADE reports with UST on psoriasis and PsA as the primary suspected agent covered 25 system organ classes (SOCs). The three most common ADEs are infections and infestations (n = 9698), general disorders and administration site conditions (n = 6336), and injury, poisoning, and procedural complications (n = 6091). Specifically, reproductive system diseases (n = 262) was identified as unique adverse reactions not mentioned in official drug labels. At the preferred term (PT) level, the most common ADEs were psoriasis exacerbation (n = 3486), lower respiratory tract infection (n = 1302) and latent tuberculosis (n = 121). Strong yet rare signals, including notalgia paraesthetica (n = 3, empirical bayesian geometric mean [EBGM] 154.7) and chronic actinic dermatitis (n = 3, EBGM 101.15), were also detected. Compared to patients with PsA, patients with psoriasis treated with UST exhibit significantly stronger associations with hepatobiliary disorders (n = 955, ROR 2.44, PRR 2.4, information component [IC] 1.26, EBGM 2.4) and neoplasms (n = 3150, ROR 2.61, PRR 2.49, IC 1.31, EBGM 2.49). Spontaneous reports consistently demonstrated higher signal strength for infections and skin disorders compared to healthcare professional (HCP) reports. In contrast, at the PT level, HCP reports tended to emphasize stronger signals for rare or specific conditions. CONCLUSION This study highlights a spectrum of UST-associated ADEs covering 25 SOCs in the treatment of patients with psoriasis and PsA, which emphasizes the need for vigilant clinical monitoring, particularly for infections, hepatobiliary disorders, and rare but high-signal events such as notalgia paraesthetica, chronic actinic dermatitis and pure testicular seminoma stage I. Clinicians should combine insights from both spontaneous and HCP reports and pay special attention to infections and reproductive system disorders.
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Affiliation(s)
- Yu Zheng
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, Jiangsu 210042, China
| | - Xiao-Jing Gao
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, Jiangsu 210042, China
| | - Ji-Jun Huang
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Xiang-Ming Chen
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Yue Liao
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Jia-Min Liu
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Yan-Ling Zheng
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Yu-Yang Zhao
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Rui-Lian Ding
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, Jiangsu 210042, China; Qingdao Municipal Center for Disease Control & Prevention, Qingdao, Shandong 266033, China
| | - Xiao-Min Li
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China
| | - Jin Bu
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, Jiangsu 210042, China.
| | - Er-Xia Shen
- Guangzhou Medical University, School of Basic Medical Sciences, Xinzao Town, Panyu District, Guangzhou, Guangdong 511436, China; Guangzhou Municipal and Guangdong Provincial Key Laboratory of Protein Modification and Degradation, School of Basic Medical Sciences, Guangzhou Medical University, Guangzhou 511436, China.
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10
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Saleh AA, Waghela R, Amini S, Moskow J, Irani M, Fan C, Glassner K, Abraham BP. A Guide to De-escalation of Combination Therapy in Inflammatory Bowel Disease: A Retrospective Cohort Study. CROHN'S & COLITIS 360 2025; 7:otaf026. [PMID: 40321837 PMCID: PMC12048838 DOI: 10.1093/crocol/otaf026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2024] [Indexed: 05/08/2025] Open
Abstract
Background Advanced combination therapy with biologics and small molecules has seen more widespread implementation for inflammatory bowel disease (IBD). However, there is a paucity of data available to guide the successful de-escalation of combination therapy following the achievement of disease remission. Therefore, we pursued this retrospective study to evaluate our center's approach to de-escalation of these patients. Methods IBD patients undergoing de-escalation of combination biologic therapy from May 2017 to March 2023 with a follow-up visit were included. The need for re-escalation, steroid therapy, and hospitalization at follow-up was compared between the de-escalation method, adherence, patient demographics, disease characteristics, and measures of disease activity. Results Fifty IBD patients underwent de-escalation, with a median age of 35.7 years. All 50 patients had a follow-up visit within a median of 168 (111) days. Patients were divided into two groups with 12 (24%) patients requiring re-escalation of therapy and 38 (76%) able to maintain or further de-escalate. Of those that required re-escalation, 3 (25%) required the use of systemic steroids and none required hospitalization for IBD. Non-adherence to the de-escalation plan significantly correlated with the need for re-escalation (P < .001). Conclusions Patient adherence and the number of prior failed biologic therapies were identified as potential risk factors for re-escalation. The type of agent being de-escalated (biologic or Janus kinase inhibitors [JAKi] did not correlate with the need for re-escalation).
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Affiliation(s)
- Adam A Saleh
- Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA
| | - Rajdeepsingh Waghela
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
| | - Shayan Amini
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
| | - Joshua Moskow
- Texas A&M College of Engineering Medicine, Houston, TX, USA
| | - Malcom Irani
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
| | - Christopher Fan
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
| | - Kerri Glassner
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
| | - Bincy P Abraham
- Houston Methodist Hospital, Underwood Center for Digestive Diseases, Fondren Inflammatory Bowel Disease Center, Houston, TX, USA
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11
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Godoy Finger AP, Tavares Ferreira de Oliveira Cruz L, Rosevics L, de Queiroz-Telles F, Beiral Hammerle M, Breda G, Kowalski Furlan T, Castro Tavares G, Cuzzi T, Zaltman C, Ramos Junior O. Management of sporotrichosis in patients with inflammatory bowel disease using biological therapy (antitumor necrosis factor). Eur J Gastroenterol Hepatol 2025; 37:370-375. [PMID: 39919009 DOI: 10.1097/meg.0000000000002907] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/09/2025]
Abstract
Antitumor necrosis factor (TNF)-alpha (TNFa) drugs are crucial for treating inflammatory bowel disease (IBD) but may increase opportunistic infection risk. Among such infections, sporotrichosis is a chronic granulomatous disease caused by saprophytic dimorphic fungi of the genus Sporothrix, which occurs worldwide. To date, there have been no reports of sporotrichosis in immunosuppressed IBD patients. The main objectives are to discuss clinical, diagnostic, and therapeutic aspects of sporotrichosis in IBD patients on anti-TNF therapy. We describe three patients with IBD on TNFa therapy who contracted cutaneous-disseminated and extracutaneous sporotrichosis and discuss strategies for managing sporotrichosis and IBD therapy in this scenario. The first case is a patient with ulcerative colitis with mild lymphocutaneous sporotrichosis who did not require discontinuation of anti-TNF agents and methotrexate. The other two patients had rapidly progressive extensive lymphocutaneous disease and disseminated sporotrichosis. These patients required hospitalization, a temporary discontinuation of their biological therapy, and a subsequent switch to vedolizumab. In all cases, the sporotrichosis was successfully treated and none of them experienced serious complications. Sporotrichosis should be considered in anti-TNF IBD patients with opportunistic infections. Early diagnosis, infection treatment, education of cat owners, and population control programs are necessary.
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Affiliation(s)
| | | | - Leticia Rosevics
- Hospital de Clínicas da Universidade Federal do Paraná, Curitiba
| | | | | | - Giovanni Breda
- Hospital de Clínicas da Universidade Federal do Paraná, Curitiba
| | | | | | - Tullia Cuzzi
- Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil
| | - Cyrla Zaltman
- Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil
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12
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Spencer EA. Long-term VEDOKIDS results: implications for practice and research. Lancet Gastroenterol Hepatol 2025; 10:189-190. [PMID: 39788135 DOI: 10.1016/s2468-1253(24)00381-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/18/2024] [Revised: 10/30/2024] [Accepted: 10/31/2024] [Indexed: 01/12/2025]
Affiliation(s)
- Elizabeth A Spencer
- Division of Pediatric Gastroenterology and Nutrition, Mount Sinai, Icahn School of Medicine, New York, NY 10029, USA.
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13
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Yeo AL, Winthrop KL. Pulmonary Complications of Biological Therapies in Inflammatory and Autoimmune Diseases. Clin Chest Med 2025; 46:169-183. [PMID: 39890287 DOI: 10.1016/j.ccm.2024.10.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/03/2025]
Abstract
Infective and noninfective pulmonary complications occur with biologic agents and targeted small molecule inhibitors used to treat immune-mediated inflammatory conditions. The most common lower respiratory tract infection is bacterial pneumonia. Opportunistic infections including tuberculosis can also occur at increased rates depending on the immunosuppressive agent, specific disease, and epidemiologic background of the patient. The most common noninfectious sequela is drug-induced interstitial lung disease.
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Affiliation(s)
- Ai Li Yeo
- Department of Rheumatology and Infectious Diseases, Monash Health, School of Clinical Sciences, Monash University, 246 Clayton Road, Clayton Melbourne, Victoria 3168, Australia.
| | - Kevin L Winthrop
- Divisions of Infectious Diseases, Ophthalmology, and Public Health, Oregon Health and Sciences University, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239, USA
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14
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Yashima K, Kurumi H, Yamaguchi N, Isomoto H. Progressing advanced therapies for inflammatory bowel disease: Current status including dual biologic therapy and discontinuation of biologics. Expert Rev Gastroenterol Hepatol 2025:1-20. [PMID: 39968880 DOI: 10.1080/17474124.2025.2469832] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2024] [Revised: 02/04/2025] [Accepted: 02/17/2025] [Indexed: 02/20/2025]
Abstract
INTRODUCTION Advanced therapies (ADT) that encompass biological agents and small molecules have been approved for the treatment of inflammatory bowel disease (IBD), broadening the spectrum of available treatment options. Nevertheless, a substantial proportion of patients fail to achieve satisfactory responses, necessitating surgical intervention. Treatment objectives have evolved beyond clinical remission, reduction of inflammation, and mucosal healing, shifting focus toward enhancing the quality of life, acknowledging the profound impact of IBD on physical and mental well-being. AREA COVERED This comprehensive review describes the current landscape of ADT for IBD, including dual biologic therapy (DBT), which involves the combination of two biologics or a single biologic with a small-molecule compound, as well as considerations surrounding the discontinuation of biologics. EXPERT OPINION ADT is the standard treatment for moderate to severe IBD, while DBT appears promising for specific subsets of patients, including those with refractory disease or extraintestinal manifestations. However, these approaches may increase the risk of adverse effects, including malignancy. To optimize individualized treatment strategies in patients with refractory IBD, further trials are needed to refine ADT's predictive value, establish DBT's safety and indications, define biologic discontinuation criteria, and evaluate emerging biomarkers, artificial intelligence, and bowel ultrasound in patient management.
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Affiliation(s)
- Kazuo Yashima
- Division of Gastroenterology and Nephrology, Faculty of Medicine, Tottori University, Yonago, Japan
| | - Hiroki Kurumi
- Division of Gastroenterology and Nephrology, Faculty of Medicine, Tottori University, Yonago, Japan
| | - Naoyuki Yamaguchi
- Department of Endoscopy, Nagasaki University Hospital, Nagasaki, Japan
| | - Hajime Isomoto
- Division of Gastroenterology and Nephrology, Faculty of Medicine, Tottori University, Yonago, Japan
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15
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Li Q, Song X, Su P, Lv X, Liu X, Chen X, Tang J, Gao X, Chao K. Risk factors and clinical characteristics of Clostridium difficile colonization and infection in patients with inflammatory bowel disease exposed to Vedolizumab: a multicenter retrospective study. Therap Adv Gastroenterol 2025; 18:17562848251321707. [PMID: 39975482 PMCID: PMC11837063 DOI: 10.1177/17562848251321707] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2024] [Accepted: 02/03/2025] [Indexed: 02/21/2025] Open
Abstract
Background Vedolizumab (VDZ), a humanized monoclonal antibody that selectively inhibits the binding of the α4β7 integrin, has been approved for treating inflammatory bowel disease (IBD). Long-term safety studies of VDZ in clinical trials identified Clostridium difficile infection (CDI) as the major opportunistic infection. Objectives We aimed to address the incidence and risk factors of C. difficile colonization (CDC) and CDI in a real-world setting among IBD patients treated with VDZ. Design Retrospective multicenter study. Methods We retrospectively included IBD patients who tested negative for C. difficile before initiating standard VDZ therapy at four tertiary hospitals from November 1, 2021, to November 31, 2023. The primary outcome was the occurrence of CDC after VDZ initiation, and the secondary outcome was the occurrence of CDI and severe CDI. Results A total of 454 patients were included in the final analysis. The median follow-up time was 12.9 (8.2-16.3) months, and the study was followed for 2488.6 person-months. The CDC occurred in 28 patients (6.2%), including 23 (11.4%) patients with ulcerative colitis (UC; 18 asymptomatic carriers and 5 with symptomatic CDI) and 5 (2.0%) patients with Crohn's disease (asymptomatic carriers). Multivariate analysis showed that age >40 years old and UC were independent risk factors for the occurrence of the CDC after VDZ initiation. The incidence of CDI was 1.1%, and all patients were able to continue VDZ therapy after receiving antibiotic treatment. No risk factors were found to be significantly associated with CDI. There were no cases of severe CDI or deaths within 30 days. Conclusion The incidence of CDC after VDZ treatment was 6.2% and the majority of patients identified as asymptomatic carriers and were able to continue VDZ treatment. Age (>40 years old) and UC were the risk factors for CDC.
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Affiliation(s)
- Qing Li
- Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
| | - Xiaomei Song
- Department of Gastroenterology, Chongqing General Hospital, Chongqing, P.R. China
| | - Peizhu Su
- Department of Gastroenterology, The First People’s Hospital of Foshan, Foshan, P.R. China
| | - Xiaoping Lv
- Department of Gastroenterology, The First Affiliated Hospital of Guangxi Medical University, Nanning, P.R. China
| | - Xinyu Liu
- Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
| | - Xuemin Chen
- Department of Gastroenterology, The First Affiliated Hospital of Guangxi Medical University, Nanning, P.R. China
| | - Jian Tang
- Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
| | - Xiang Gao
- Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
| | - Kang Chao
- Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-sen University, No. 26 Yuancun Road II, Tianhe District, Guangzhou 510000, P.R. China
- Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
- Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, P.R. China
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16
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Zhu JW, Wang HM, Aisikaer M, Zhou WJ, Yang TT, Aximujiang K. Application of Chinese Medicine in Treatment of Ulcerative Colitis and Elucidation of Relevant Mechanisms. Chin J Integr Med 2025:10.1007/s11655-025-3824-y. [PMID: 39821880 DOI: 10.1007/s11655-025-3824-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/19/2024] [Indexed: 01/19/2025]
Abstract
Ulcerative colitis (UC) is a chronic, non-specific intestinal disease of unknown etiology, with high incidence rates worldwide. At present, Western medicine treatments have been associated with more adverse effects and poor efficacy. Chinese medicine (CM) is commonly used as an adjuvant treatment for the unique advantages in regulating immune function, repairing intestinal mucosa, and alleviating intestinal inflammation. At the same time, network pharmacology is also providing new ideas and innovations about CM and development of new drugs. This review systematically discusses the progress of research regarding UC treatment using CM, with a main focus on intestinal flora balance, intestinal mucosal barrier, CM enema, acupuncture therapy, and acupoint embedding. This study provides new ideas that clarify the therapeutic targets of UC.
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Affiliation(s)
- Ji-Wei Zhu
- Xinjiang Medical University, Urumqi, 830017, China
| | | | | | - Wen-Jun Zhou
- Xinjiang Medical University, Urumqi, 830017, China
| | | | - Kasimujiang Aximujiang
- Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Xinjiang Medical University, Urumqi, 830017, China.
- Xinjiang Key Laboratory of Molecular Biology for Endemic Disease, Urumqi, 830017, China.
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17
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Bhaskar S, Makovich Z, Mhaskar R, Coughlin E, Seminerio-Diehl J. Exploring Dual-Targeted Therapy in the Management of Moderate to Severe Inflammatory Bowel Disease: A Retrospective Study. CROHN'S & COLITIS 360 2025; 7:otae057. [PMID: 39877297 PMCID: PMC11772558 DOI: 10.1093/crocol/otae057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/20/2024] [Indexed: 01/31/2025] Open
Abstract
Background Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), often results in significant morbidity among patients with moderate to severe forms. While biologics and small molecules are effective in inducing remission, many patients experience refractory disease or extraintestinal manifestations. This study assesses the safety and efficacy of dual-targeted therapy in IBD patients treated at the Inflammatory Bowel Disease Center. Methods This retrospective cohort study examined 79 patients with UC or CD who received dual-targeted therapy at the University from October 2018 to August 2023. Data collected included demographics, disease characteristics, previous treatments, and clinical outcomes. Primary outcomes were endoscopic, radiographic, and patient-reported clinical improvements, with secondary outcomes focusing on safety profiles. Results Among the 79 patients (42 UC, 37 CD), 97 dual-targeted therapy cases were analyzed, primarily involving a biologic combined with a JAK inhibitor (90.7%). The median therapy duration was 39.1 weeks. Endoscopic improvement occurred in 69% of matched samples, with significant differences between pre- and postdual-targeted therapy Mayo scores for UC (P = .002) and Simple Endoscopic Score for CD (SES-CD) scores for CD (P = .018). The median pre- and postdual-targeted therapy Mayo scores across matched samples were 3 (range 1-3) and 1 (range 0-3), respectively, and for SES-CD scores were 12 (range 0-36) and 4 (range 0-20), respectively. Clinical improvement was reported by 73.2% of patients, with notable reductions in ESR (median 19 [range 2-124] mm/h to 9 [range 0-116] mm/h, P = .006), CRP (median 8.0 [range 0.2-78.5] mg/L to 3.0 [range 0.2-68.2] mg/L, P < .001), and albumin levels (4.0 [range 2.2-4.9] mg/dL to 4.2 [range 3.4-5.2], P < .001). Non-obesity was associated with both more endoscopic improvement (P = .002) and clinical improvement (P = .007). Adverse events occurred in 37 cases, predominantly upper respiratory tract infections and dermatologic issues, with no thromboembolic events reported. Conclusions Dual-targeted therapy demonstrated efficacy in improving clinical and endoscopic outcomes in patients with severe, refractory IBD and exhibited an acceptable safety profile. Despite the promising results, further research is needed to confirm these findings and determine optimal therapy combinations.
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Affiliation(s)
- Sonya Bhaskar
- Division of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, Tampa, FL, USA
| | - Zachary Makovich
- Division of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, Tampa, FL, USA
| | - Rahul Mhaskar
- Division of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, Tampa, FL, USA
| | - Emily Coughlin
- Division of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, Tampa, FL, USA
| | - Jennifer Seminerio-Diehl
- Division of Digestive Diseases and Nutrition, Morsani College of Medicine, University of South Florida, Tampa, FL, USA
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18
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Rezaei S, Ghorbani E, Al-Asady AM, Avan A, Soleimanpour S, Khazaei M, Hassanian SM. Evaluating the Therapeutic Efficacy of Lactobacillus Strains in the Management of Ulcerative Colitis: An Overview of Recent Advances. Curr Pharm Des 2025; 31:413-421. [PMID: 39385420 DOI: 10.2174/0113816128322653240925115114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2024] [Revised: 08/02/2024] [Accepted: 08/20/2024] [Indexed: 10/12/2024]
Abstract
Ulcerative Colitis (UC) known as a sub-category of Inflammatory Bowel Diseases (IBD) is a longterm condition that causes inflammation, irritation, and ulcers in the colon and rectum. Though the precise pathogenesis of UC is not fully understood yet, impaired immune responses and imbalanced intestinal microbiome composition have been regarded as two main key players in colitis pathobiology. As conventional treatments are challenged with limitations and side effects, finding a new therapeutic approach has gained increasing attention. Probiotic bacteria with multifunctional health-promoting properties have been considered novel therapeutic options. There is strong evidence indicating that probiotics exert their therapeutic effects mostly by regulating immune system responses and restoring gut microbiome homeostasis. These results validate the rationale behind the clinical application of probiotics in UC management whether prescribed alone or in combination with conventional therapy. This article explores the pathogenesis of UC, concentrating on the influence of immune dysregulation and intestinal microbiome imbalances. Also, it reviews recent in vitro, in vivo, and clinical studies that have demonstrated the efficacy of Lactobacillus species in decreasing UC symptoms by modifying immune responses, restoring gut microbiota balance, and promoting intestinal barrier function.
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Affiliation(s)
- Shaghayegh Rezaei
- Department of Microbiology and Virology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Elnaz Ghorbani
- Department of Microbiology and Virology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Abdulridha Mohammed Al-Asady
- Department of Medical Sciences, Faculty of Nursing, Warith Al-Anbiyaa University, Karbala, Iraq
- Department of Medical Sciences, Faculty of Dentistry, University of Kerbala, Karbala, Iraq
- Department of Pharmacology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Amir Avan
- Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Saman Soleimanpour
- Department of Microbiology and Virology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
- Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Majid Khazaei
- Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
- Department of Medical Physiology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Seyed Mahdi Hassanian
- Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
- Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
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19
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Nicolò S, Faggiani I, Errico C, D'Amico F, Parigi TL, Danese S, Ungaro F. Translational characterization of immune pathways in inflammatory bowel disease: insights for targeted treatments. Expert Rev Clin Immunol 2025; 21:55-72. [PMID: 39313992 DOI: 10.1080/1744666x.2024.2400300] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2024] [Accepted: 08/30/2024] [Indexed: 09/25/2024]
Abstract
INTRODUCTION The pathogenesis of inflammatory bowel disease (IBD) involves the dysregulation of multiple inflammatory pathways. The understanding of these mechanisms allows their selective targeting for therapeutic purposes. The discovery of Tumor Necrosis Factor-alpha's (TNF-α) role in mucosal inflammation ushered an exciting new era of drug development which now comprises agents targeting multiple pro-inflammatory signaling pathways, integrins, and leukocyte trafficking regulators. AREA COVERED This review provides an overview of the main molecular players of IBD, their translation into therapeutic targets and the successful development of the advanced agents modulating them. We combine basic science with clinical trials data to present a critical review of both the successful and failed drug development programs. A PubMed literature search was conducted to delve into the available literature and clinical trials. EXPERT OPINION The treatment landscape for IBD has rapidly expanded, particularly with the development of biologics targeting TNF-α, integrins, and S1P modulators, as well as newer agents such as IL-12/IL-23 inhibitors and JAK inhibitors, offering robust efficacy and safety profiles. However, challenges persist in understanding and effectively treating difficult-to-treat IBD, highlighting the need for continued research to uncover novel therapeutic targets and optimize patient outcomes.
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Affiliation(s)
- Sabrina Nicolò
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
| | - Ilaria Faggiani
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
| | - Carmela Errico
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
| | - Ferdinando D'Amico
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
| | - Tommaso Lorenzo Parigi
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
| | - Federica Ungaro
- Department of Gastroenterology and Digestive Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy
- Faculty of Medicine, Università Vita-Salute San Raffaele, Milan, Italy
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20
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Azzam N, Alharbi O, Altuwaijri M, Alruthia Y, Alfarhan H, Alshankiti S, Nafisah F, Ajlan Q, Aljebreen A, Almadi M, Mosli MH. The effectiveness of vedolizumab in advanced therapy-experienced ulcerative colitis patients: Real world data from the Inflammatory Bowel Disease of the Middle East (IBD-ME) Registry group. Saudi J Gastroenterol 2025; 31:34-40. [PMID: 39291466 PMCID: PMC11804962 DOI: 10.4103/sjg.sjg_249_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2024] [Revised: 08/09/2024] [Accepted: 08/23/2024] [Indexed: 09/19/2024] Open
Abstract
BACKGROUND Vedolizumab is an approved ulcerative colitis (UC) treatment. Multiple large randomized clinical trials have demonstrated the drug's efficacy and safety. However, real-world data from Middle Eastern countries are spare. The study aims to evaluate the clinical efficacy of vedolizumab (VDZ) therapy in advanced therapy experienced UC patients. METHODS A retrospective electronic chart review of a cohort study of 153 moderately to severely active UC patients who failed or were intolerant to TNF antagonists and received vedolizumab from two large tertiary care centers was performed. Rates of clinical response and remission were retrospectively evaluated at 3,6, and 12 months post VDZ therapy using Patient Simple Clinical Colitis Activity Index (P-SCCAI); clinical response was defined as a decrease in P-SCCAI ≥3, and clinical remission was defined as a P-SCCAI score of ≤3 points. Logistic regression analysis was used to identify predictors of response to vedolizumab. RESULTS A total of 153 UC patients had sufficient data for analysis. Clinical remission rates were 61.9% for patients on vedolizumab every 8 weeks and 89.3% for those receiving every 4 (Q4) weeks dosing. A significant reduction in CRP and improvement of albumin post vedolizumab treatment were observed, and corticosteroids were stopped in most patients. In a multiple logistic regression analysis, several factors were found to influence the clinical effectiveness of VDZ in inducing remission. Female gender was associated with a higher likelihood of remission [OR =3.09, 95% CI = (1.05-9.13), P = 0.04]. Conversely, a greater number of biologics used prior to VDZ treatment was associated with a lower likelihood of remission [OR =0.418, 95% CI = (0.203-0.859), P = 0.017]. Patients with extensive disease (E3) had an increased likelihood of remission [OR =3.81, 95% CI = (1.32-10.97), P = 0.0129]. Additionally, a VDZ dosing frequency of Q4 weeks was associated with a significantly higher likelihood of remission [OR =6.08, 95% CI = (1.73-21.39), P = 0.0049]. No significant safety signals were reported. CONCLUSIONS In this current real-world study, vedolizumab effectively achieved clinical response and remission in most advanced therapy experienced UC patients treated for up to 12 months. Future studies with larger sample sizes and more robust study designs should be conducted to further validate the results of this study.
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Affiliation(s)
- Nahla Azzam
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Othman Alharbi
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Mansour Altuwaijri
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Yazed Alruthia
- Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
- Department of Clinical Pharmacy, Pharmacoeconomics Research Unit, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia
| | - Heba Alfarhan
- Department of Internal Medicine, Division of Gastroenterology, Thunayan Al Ghanim Gastroenterology Center at Al Amiri Hospital, Kuwait City, Kuwait
| | - Suliman Alshankiti
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Faris Nafisah
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Qusay Ajlan
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Abdulrahman Aljebreen
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
| | - Majid Almadi
- Department of Medicine, Division of Gastroenterology, College of Medicine, King Saud University, Riyadh, Saudi Arabia
- Department of Medicine, Division of Gastroenterology, The McGill University Health Center, Montreal General Hospital, McGill University, Montreal, Canada
| | - Mahmoud H. Mosli
- Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
- Inflammatory Bowel Disease Unit, King Abdulaziz University Hospital, Jeddah, Saudi Arabia
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21
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Karlqvist S, Sachs MC, Eriksson C, Cao Y, Montgomery S, Ludvigsson JF, Olén O, Halfvarson J. Response to Dai et al. Am J Gastroenterol 2025; 120:260-261. [PMID: 39718002 DOI: 10.14309/ajg.0000000000003199] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/25/2024]
Affiliation(s)
- Sara Karlqvist
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
| | - Michael C Sachs
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
- Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | - Carl Eriksson
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
- Department of Medicine Solna, Clinical Epidemiology Division, Karolinska Institute, Stockholm, Sweden
| | - Yang Cao
- Clinical Epidemiology and Biostatistics, Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden
- Unit of Integrative Epidemiology, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden
| | - Scott Montgomery
- Department of Medicine Solna, Clinical Epidemiology Division, Karolinska Institute, Stockholm, Sweden
- Clinical Epidemiology and Biostatistics, Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden
- Department of Epidemiology and Public Health, University College London, London, UK
| | - Jonas F Ludvigsson
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
- Department of Paediatrics, Örebro University Hospital, Örebro, Sweden
- Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York, USA
| | - Ola Olén
- Department of Medicine Solna, Clinical Epidemiology Division, Karolinska Institute, Stockholm, Sweden
- Department of Clinical Science and Education, Sachs' Children and Youth Hospital, Stockholm South General Hospital, Karolinska Institute, Stockholm, Sweden
| | - Jonas Halfvarson
- Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden
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22
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Karp J, Shen H, Goodwin T, Sparrow MP. Anaphylaxis to a Vedolizumab Infusion following Drug Holiday in a Patient with Ulcerative Colitis: A Case Report. Case Rep Gastroenterol 2025; 19:62-66. [PMID: 39981168 PMCID: PMC11820661 DOI: 10.1159/000543387] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Accepted: 12/23/2024] [Indexed: 02/22/2025] Open
Abstract
Introduction Vedolizumab is a commonly prescribed biologic agent due to its safety profile and clinical efficacy. Severe infusion-related reactions are exceedingly rare, with no previously documented cases of anaphylaxis to vedolizumab infusion following a drug holiday. Case Presentation We report the case of a 65-year-old male with ulcerative colitis who had a severe anaphylactic reaction to the first re-induction infusion of vedolizumab following a 30-month drug holiday. No pre-infusion prophylactic medication was administered. Upon commencement of the infusion, the patient developed anaphylactic symptoms including airway compromise that required intensive care unit admission and treatment with an adrenaline infusion. Conclusion Anaphylactic reactions to vedolizumab after a drug holiday can occur. As is done for infliximab, we recommend administration of an antipyretic, antihistamine, and corticosteroid prior to vedolizumab re-induction infusions when it is given after a drug holiday.
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Affiliation(s)
- Jadon Karp
- Department of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia
| | - Henry Shen
- Department of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia
| | - Thomas Goodwin
- Department of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia
| | - Miles P. Sparrow
- Department of Gastroenterology, The Alfred Hospital, Melbourne, VIC, Australia
- School of Translational Medicine, Monash University, Melbourne, VIC, Australia
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23
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Dai C, Huang YH, Jiang M. Comparative Risk of Serious Infection With Vedolizumab vs Anti-Tumor Necrosis Factors in Inflammatory Bowel Disease. Am J Gastroenterol 2025; 120:259. [PMID: 39158155 DOI: 10.14309/ajg.0000000000002995] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2024] [Accepted: 07/22/2024] [Indexed: 08/20/2024]
Affiliation(s)
- Cong Dai
- Department of Gastroenterology, First Affiliated Hospital, China Medical University, Shenyang, Liaoning, China
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24
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Ma J, Chong J, Qiu Z, Wang Y, Chen T, Chen Y. Efficacy of different dietary therapy strategies in active pediatric Crohn's disease: a systematic review and network meta-analysis. PeerJ 2024; 12:e18692. [PMID: 39686992 PMCID: PMC11648686 DOI: 10.7717/peerj.18692] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/25/2024] [Accepted: 11/20/2024] [Indexed: 12/18/2024] Open
Abstract
BACKGROUND Dietary therapy strategies play an important role in the treatment of pediatric patients with Crohn's disease (CD), but the relative efficacy of different dietary therapy strategies for Crohn's remission is unknown. This study aims to compare the effectiveness and tolerance of these dietary therapy strategies for active pediatric CD. METHODS We searched the medical literature up to August 30, 2024 to identify randomized controlled trials (RCTs) of dietary therapy strategies for pediatric CD. The primary outcomes were clinical remission rate and tolerance, secondary outcomes included differences between pre- and post-treatment levels of albumin, C-reactive protein (CRP), and fecal calprotectin levels. A network meta-analysis (NMA) was performed by using the frequentist model. For binary outcome variables and continuous outcome variables, odds ratios (OR) and mean differences (MD) with corresponding 95% confidence intervals (CI) were utilized, respectively. The ranking of dietary therapy strategies was determined based on the surface under the cumulative ranking area (SUCRA) for each comparison analyzed. RESULTS Overall, 14 studies involving 564 participants were included. In terms of clinical remission rate, the partial enteral nutrition (PEN) plus Crohn's disease exclusion diet (PEN+CDED) (OR = 7.86, 95% CI [1.85-33.40]) and exclusive enteral nutrition (EEN) (OR = 3.74, 95% CI [1.30-10.76]) exhibited significant superiority over PEN alone. The tolerance of PEN+CDED was significantly higher than that of EEN (OR = 0.07, 95% CI [0.01-0.61]). According to the surface under the cumulative ranking area (SUCRA) values, the PEN+CDED intervention (90.5%) achieved the highest ranking in clinical remission rate. In terms of tolerance, PEN+CDED ranked first (88.0%), while EEN ranked last (16.3%). CONCLUSIONS In conclusion, PEN+CDED was associated with the highest clinical remission rate and tolerance among the various dietary therapy strategies evaluated. Despite limitations in the studies, this systematic review provides evidence that PEN+CDED can be used as an alternative treatment to exclusive enteral nutrition and is more suitable for long-term management in children.
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Affiliation(s)
- Jiaze Ma
- The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China
| | - Jinchen Chong
- The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China
| | - Zhengxi Qiu
- The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China
| | - Yuji Wang
- The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China
| | - Tuo Chen
- Department of General Surgery, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China
| | - Yugen Chen
- The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
- Jiangsu Collaborative Innovation Center of Chinese Medicine in Prevention and Treatment of Tumor, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China
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25
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Lagrange J, Ahmed MU, Arnone D, Lacolley P, Regnault V, Peyrin-Biroulet L, Denis CV. Implications of von Willebrand Factor in Inflammatory Bowel Diseases: Beyond Bleeding and Thrombosis. Inflamm Bowel Dis 2024; 30:2500-2508. [PMID: 38960879 DOI: 10.1093/ibd/izae142] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2024] [Indexed: 07/05/2024]
Abstract
Inflammatory bowel disease (IBD) displays an increased venous and arterial thrombotic risk despite the common occurrence of intestinal bleeding. While some of the mechanisms leading to these thrombotic complications have been studied, other specific changes in the hemostasis profile of IBD patients have been less explored. One such example relates to von Willebrand factor (VWF) whose plasma levels have been reported to be modulated in IBD. Von Willebrand factor is a plasma glycoprotein crucial for hemostatic functions via roles both in platelet function and coagulation. High plasma VWF is a known risk factor for venous thromboembolism. In addition to its canonical roles in hemostasis, VWF is known to be directly or indirectly involved in other vascular processes such as maintenance of endothelial barrier integrity or proliferation of vascular smooth muscle cells. The purpose of this review is to recapitulate and update the existing data about VWF biology in IBD and to highlight its role both in the existing procoagulant phenotype and in vascular alterations that may occur in IBD.
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Affiliation(s)
- Jérémy Lagrange
- Université de Lorraine, INSERM, DCAC, Nancy, France
- CHRU Nancy, IHU INFINY, Vandœuvre-lès-Nancy, France
| | | | - Djésia Arnone
- Université de Lorraine, INSERM, NGERE, IHU INFINY, Nancy, France
| | | | | | - Laurent Peyrin-Biroulet
- Université de Lorraine, INSERM, NGERE, IHU INFINY, Nancy, France
- Department of Gastroenterology, CHRU Nancy, Vandœuvre-lès-Nancy, France
- Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD center, Neuilly sur Seine, France
| | - Cécile V Denis
- HITh, UMR_S1176, INSERM, Université Paris-Saclay, Le Kremlin-Bicêtre, France
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26
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Johnson AM, Loftus EV. An evaluation of risankizumab for the treatment of moderate-to-severe ulcerative colitis. Expert Opin Biol Ther 2024; 24:1317-1327. [PMID: 39530131 DOI: 10.1080/14712598.2024.2428311] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2024] [Accepted: 11/07/2024] [Indexed: 11/16/2024]
Abstract
INTRODUCTION Risankizumab (RZB) is a recombinant IgG1 humanized monoclonal antibody which selectively inhibits interleukin (IL)-23 though high-affinity binding of the p19 subunit. RZB was approved for use in Crohn's disease (CD) in 2022 and received regulatory approval for ulcerative colitis (UC) in the United States in June 2024. AREAS COVERED We will examine currently available therapies for UC, provide an overview of the IL-23 pathway, discuss available trial data for RZB in UC, and comment on how RZB may fit into the current UC treatment paradigm and future directions in the field. EXPERT OPINION RZB appears to be an effective agent for inducing and maintaining remission in patients with both treatment-naïve and refractory UC, with a favorable safety profile. The selective blockade of IL-23 has demonstrated potential advantages in efficacy over combined IL-12/23 inhibition for other disease states like CD and psoriasis, although where it will be positioned amidst other clinically available advanced therapies in UC requires further study.
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Affiliation(s)
- Amanda M Johnson
- Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA
| | - Edward V Loftus
- Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA
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27
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Yue N, Hu P, Tian C, Kong C, Zhao H, Zhang Y, Yao J, Wei Y, Li D, Wang L. Dissecting Innate and Adaptive Immunity in Inflammatory Bowel Disease: Immune Compartmentalization, Microbiota Crosstalk, and Emerging Therapies. J Inflamm Res 2024; 17:9987-10014. [PMID: 39634289 PMCID: PMC11615095 DOI: 10.2147/jir.s492079] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2024] [Accepted: 11/12/2024] [Indexed: 12/07/2024] Open
Abstract
The intestinal immune system is the largest immune organ in the human body. Excessive immune response to intestinal cavity induced by harmful stimuli including pathogens, foreign substances and food antigens is an important cause of inflammatory diseases such as celiac disease and inflammatory bowel disease (IBD). Although great progress has been made in the treatment of IBD by some immune-related biotherapeutic products, yet a considerable proportion of IBD patients remain unresponsive or immune tolerant to immunotherapeutic strategy. Therefore, it is necessary to further understand the mechanism of immune cell populations involved in enteritis, including dendritic cells, macrophages and natural lymphocytes, in the steady-state immune tolerance of IBD, in order to find effective IBD therapy. In this review, we discussed the important role of innate and adaptive immunity in the development of IBD. And the relationship between intestinal immune system disorders and microflora crosstalk were also presented. We also focus on the new findings in the field of T cell immunity, which might identify novel cytokines, chemokines or anti-cytokine antibodies as new approaches for the treatment of IBD.
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Affiliation(s)
- Ningning Yue
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Peng Hu
- School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, People’s Republic of China
| | - Chengmei Tian
- Department of Emergency, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Chen Kong
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Hailan Zhao
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Yuan Zhang
- Department of Medical Administration, Huizhou Institute of Occupational Diseases Control and Prevention, Huizhou, People’s Republic of China
| | - Jun Yao
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Yuqi Wei
- Department of Rehabilitation, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Defeng Li
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
| | - Lisheng Wang
- Department of Gastroenterology, Shenzhen People’s Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, People’s Republic of China
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Dar L, Shani U, Dotan A, Ukashi O, Ben-Horin S, Kopylov U, Levartovsky A. Short-term effectiveness and safety of ustekinumab and vedolizumab in elderly and non-elderly patients with Crohn's disease: a comparative study. Therap Adv Gastroenterol 2024; 17:17562848241299752. [PMID: 39569055 PMCID: PMC11577457 DOI: 10.1177/17562848241299752] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2024] [Accepted: 10/28/2024] [Indexed: 11/22/2024] Open
Abstract
Background Inflammatory bowel disease (IBD) presents unique challenges in elderly patients due to comorbidities and treatment-related risks. Objectives This study evaluates ustekinumab (UST) and vedolizumab (VDZ) efficacy and safety in elderly Crohn's disease (CD) patients. Design A retrospective cohort study at a tertiary medical center. Methods CD patients aged ⩾60 years (elderly) treated with UST, compared to non-elderly (<60 years) patients treated with UST and elderly patients treated with VDZ. Clinical response was evaluated using the Harvey-Bradshaw index (HBI) and clinical biomarkers, alongside monitoring steroid use, hospitalization rates, treatment persistence, and surgical interventions. Results The study included 166 CD patients: 32 elderly and 65 non-elderly patients treated with UST, and 69 elderly patients treated with VDZ. The mean duration of follow-up was 10.8 ± 2.8 months in the non-elderly group, 9.97 ± 3.28 months in the elderly UST group, and 10.0 ± 3.29 months in the VDZ group. Elderly UST patients were more likely to receive corticosteroids at initiation than non-elderly UST patients (44% vs 14%, p = 0.001). At 12 months, clinical response rates did not significantly differ between elderly and non-elderly UST groups, respectively (48% vs 40%, p = 0.5). However, elderly UST patients exhibited higher hospitalization rates over time compared to non-elderly UST patients (6-month: 19% vs 6.2%, p = 0.077; 12-month: 19% vs 4.6%, p = 0.055; log-rank p = 0.004). No significant differences were observed in clinical response and remission rates between elderly UST and elderly VDZ patients at 6 and 12 months. At 6 months, a higher hospitalization rate was observed in the UST group (19% vs 4.3% p = 0.027), but this difference did not persist over time. Conclusion UST and VDZ are effective and safe treatments for elderly CD patients, despite higher hospitalization rates compared to non-elderly patients, likely due to age-related complications.
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Affiliation(s)
- Lior Dar
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer 52621, Israel
| | - Uria Shani
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Israel
- Faculty of Medical and Health Sciences, Tel-Aviv University, Israel
| | - Arad Dotan
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Israel
- Faculty of Medical and Health Sciences, Tel-Aviv University, Israel
| | - Offir Ukashi
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Israel
- Faculty of Medical and Health Sciences, Tel-Aviv University, Israel
| | - Shomron Ben-Horin
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Israel
- Faculty of Medical and Health Sciences, Tel-Aviv University, Israel
| | - Uri Kopylov
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer, Israel
- Faculty of Medical and Health Sciences, Tel-Aviv University, Israel
| | - Asaf Levartovsky
- Department of Gastroenterology, Sheba Medical Center, Tel-Hashomer 52621, Israel
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29
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Alghamdi M, Alyousfi D, Mukhtar MS, Mosli M. Association between vedolizumab and risk of clostridium difficile infection in patients with ulcerative colitis: A systematic review and meta-analysis. Saudi J Gastroenterol 2024; 30:346-352. [PMID: 38847060 PMCID: PMC11630484 DOI: 10.4103/sjg.sjg_118_24] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2024] [Revised: 04/16/2024] [Accepted: 05/04/2024] [Indexed: 11/08/2024] Open
Abstract
BACKGROUND The medical treatment of ulcerative colitis (UC) includes the use of biological agents such as vedolizumab, a gut-selective alpha4beta7 (ɑ4β7) antagonist. The mechanism of action of vedolizumab involves interfering with leukocyte trafficking into the gut vasculature, which halts inflammation. Due to this mechanism of action, concerns have arisen regarding an increased risk of gut infections, specifically, clostridium difficile infection (CDI). The aim is to provide clarity regarding the association between the use of vedolizumab as a therapy for ulcerative colitis and the risk of developing CDI. METHODS A systematic literature review was conducted, starting with the scoping search, followed by backward snowballing parallel with keyword-based search to identify related articles. A quality assessment was conducted on the initially selected articles and excluded low-quality papers. RESULTS Pooled analyses indicated that there was no significant association between the use of vedolizumab and the risk of developing CDI (effect size = 0.03 [-0.02, 0.07]). CONCLUSIONS Vedolizumab does not increase the risk of CDI in patients with UC. Further studies are needed to confirm these findings.
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Affiliation(s)
- Maha Alghamdi
- Department of Internal Medicine, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi Arabia
| | - Dareen Alyousfi
- Department of Clinical Biochemistry, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Mariam S. Mukhtar
- Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
| | - Mahmoud Mosli
- Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
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30
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Murthy SK, Tandon P, Matthews P, Ahmed F, Pugliese M, Taljaard M, Kaplan GG, Coward S, Bernstein C, Benchimol EI, Kuenzig ME, Targownik LE, Singh H. A Population-Based Matched Cohort Study of Digestive System Cancer Incidence and Mortality in Individuals With and Without Inflammatory Bowel Disease. Am J Gastroenterol 2024; 119:2275-2287. [PMID: 38916226 PMCID: PMC11524629 DOI: 10.14309/ajg.0000000000002900] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2024] [Accepted: 06/12/2024] [Indexed: 06/26/2024]
Abstract
INTRODUCTION To study digestive system cancer risks in individuals with inflammatory bowel diseases (IBDs) in the biologic era. METHODS We used population-level administrative and cancer registry data from Ontario, Canada, (1994-2020) to compare people with IBD to matched controls (1:10 by sex and birth year) on trends in age-sex standardized cancer incidence and risk ratios of incident cancers and cancer-related deaths. RESULTS Among 110,919 people with IBD and 1,109,190 controls, colorectal cancer incidence (per 100,000 person-years) declined similarly in people with ulcerative colitis (average annual percentage change [AAPC] -1.81; 95% confidence interval [CI] -2.48 to -1.156) and controls (AAPC -2.79; 95% CI -3.44 to -2.14), while small bowel cancer incidence rose faster in those with Crohn's disease (AAPC 9.68; 95% CI 2.51-17.3) than controls (AAPC 3.64; 95% CI 1.52-5.80). Extraintestinal digestive cancer incidence rose faster in people with IBD (AAPC 3.27; 95% CI 1.83-4.73) than controls (AAPC -1.87; 95% CI -2.33 to -1.42), particularly for liver (IBD AAPC 8.48; 95% CI 4.11-13.1) and bile duct (IBD AAPC 7.22; 95% CI 3.74-10.8) cancers. Beyond 2010, the incidences (and respective mortality rates) of colorectal (1.60; 95% CI 1.46-1.75), small bowel (4.10; 95% CI 3.37-4.99), bile duct (2.33; 95% CI 1.96-2.77), and pancreatic (1.19; 95% CI 1.00-1.40) cancers were higher in people with IBD. DISCUSSION Cancer incidence is declining for colorectal cancer and rising for other digestive cancers in people with IBD. Incidence and mortality remain higher in people with IBD than controls for colorectal, small bowel, bile duct, and pancreatic cancers.
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Affiliation(s)
- Sanjay K. Murthy
- Department of Medicine and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
- The Ottawa Hospital, IBD Centre, Ottawa, Ontario, Canada
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- ICES, Toronto, Canada
| | - Parul Tandon
- ICES, Toronto, Canada
- Division of Gastroenterology and Hepatology, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | | | - Faria Ahmed
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | | | - Monica Taljaard
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- ICES, Toronto, Canada
| | - Gilaad G. Kaplan
- Department of Medicine and Community Health Sciences, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Stephanie Coward
- Department of Medicine and Community Health Sciences, Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Charles Bernstein
- University of Manitoba IBD Clinical and Research Centre, Winnipeg, Manitoba, Canada
- Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Eric I. Benchimol
- ICES, Toronto, Canada
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
- Department of Paediatrics and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada
| | - M. Ellen Kuenzig
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - Laura E. Targownik
- Mount Sinai Hospital IBD Centre, Toronto, Ontario, Canada
- Division of Gastroenterology and Hepatology, University of Toronto, Ontario, Canada
| | - Harminder Singh
- University of Manitoba IBD Clinical and Research Centre, Winnipeg, Manitoba, Canada
- Departments of Internal Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
- Paul Albrechtsen Research Institute CancerCare Manitoba, Winnipeg, Manitoba, Canada
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Toiv A, Harris KB, Khan MZ, Theisen BK, Varma A, Fain C, Kaur N. Dynamic Presentations of Recurrent Post-Transplant Lymphoproliferative Disorder in a Heart Transplant Recipient: A Rare Case Study. ACG Case Rep J 2024; 11:e01554. [PMID: 39568982 PMCID: PMC11578195 DOI: 10.14309/crj.0000000000001554] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/17/2024] [Accepted: 10/15/2024] [Indexed: 11/22/2024] Open
Abstract
Post-transplant lymphoproliferative disorders (PTLD) are complications that arise from post-transplantation immunosuppressive therapy. Although Epstein-Barr virus (EBV) viremia is often seen in PTLD, it is not a definitive feature for diagnosis. We report a rare case of recurrent PTLD in a 26-year-old heart transplant recipient on high-dose tacrolimus who presented with emesis, fatigue, and bloody diarrhea. Although substantial EBV viremia was seen in the first PTLD episode, the current episode was a gastrointestinal manifestation with barely detectable circulating EBV. The patient's history of gastrointestinal disease delayed definitive diagnosis, which was later established through endoscopy and biopsy sample analysis.
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Affiliation(s)
- Avi Toiv
- Department of Internal Medicine, Henry Ford Hospital, Detroit, MI
| | - Kevin B Harris
- Division of Gastroenterology, Henry Ford Hospital, Detroit, MI
| | | | | | - Adarsh Varma
- Division of Gastroenterology, Henry Ford Hospital, Detroit, MI
| | | | - Nirmal Kaur
- Division of Gastroenterology, Henry Ford Hospital, Detroit, MI
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Chen W, Liu Y, Zhang Y, Zhang H, Chen C, Zhu S, Zhou Y, Zhao H, Zong Y. Risk of Clostridioides difficile infection in inflammatory bowel disease patients undergoing vedolizumab treatment: a systematic review and meta-analysis. BMC Gastroenterol 2024; 24:377. [PMID: 39448963 PMCID: PMC11515399 DOI: 10.1186/s12876-024-03460-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2024] [Accepted: 10/14/2024] [Indexed: 10/26/2024] Open
Abstract
BACKGROUND Inflammatory bowel disease (IBD) is a chronic, relapsing condition wherein biologics have improved disease prognosis but introduced elevated infection susceptibility. Vedolizumab (VDZ) demonstrates unique safety advantages; however, a comprehensive systematic comparison regarding the risk of Clostridioides difficile infection (CDI) between vedolizumab and alternative medications remains absent. METHOD Medline, Embase, Cochrane, and clinicaltrials.gov registry were comprehensively searched. Pooled estimates of CDI proportion, incidence, pooled risk ratio between ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab and other medications were calculated. Data synthesis was completed in R using the package "meta". RESULTS Of the 338 studies initially identified, 30 met the inclusion/exclusion criteria. For CDI risk, the pooled proportion was 0.013 (95% CI 0.010-0.017), as well as the pooled proportion of serious CDI was 0.004 (95% CI 0.002-0.008). The comparative pooled risk ratios revealed: UC versus CD at 2.25 (95% CI 1.73-2.92), vedolizumab versus anti-TNF agents at 0.15 (95% CI 0.04-0.63) for UC and 1.29 (95% CI 0.41-4.04) for CD. CONCLUSION The overall CDI risk in IBD patients exposed to vedolizumab was estimated to be 0.013. An increased risk of CDI was noted in UC patients receiving vedolizumab compared to those with CD. Vedolizumab potentially offers an advantage over anti-TNF agents for UC regarding CDI risk, but not for CD. TRIAL REGISTRATION The study was registered on the PROSPERO registry (CRD42023465986).
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Affiliation(s)
- Wei Chen
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Yuhang Liu
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Yuelun Zhang
- Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Hong Zhang
- Wenzhou Integrated Traditional Chinese and Western Medicine Hospital Pharmacy Department, Wenzhou, Zhejiang Province, China
| | - Chuyan Chen
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Siying Zhu
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Yanhua Zhou
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Haiying Zhao
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China
| | - Ye Zong
- Department of Gastroenterology, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing Digestive Disease Center, Beijing Friendship Hospital, National Clinical Research Center for Digestive Disease, Capital Medical University, 95 Yong-an Road, Xi- cheng District, Beijing, China.
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Kudrina I, Page MG, Choinière M, Shir Y, Eisenberg MJ, Ben-Sasson M, Lebouché B, Puzhko S. Risk of infections among persons treated with opioids for chronic pain: a systematic review and meta-analysis protocol. BMJ Open 2024; 14:e083791. [PMID: 39414287 PMCID: PMC11481125 DOI: 10.1136/bmjopen-2023-083791] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2023] [Accepted: 09/20/2024] [Indexed: 10/18/2024] Open
Abstract
INTRODUCTION Millions of persons with chronic pain across North America and Europe use opioids. While the immunosuppressive properties of opioids are associated with risks of infections, these outcomes could be mitigated through careful patient selection and monitoring practices when appropriate. It is important to recognise that some patients do benefit from a carefully tailored opioid therapy. Enough primary studies have been published to date regarding the role of opioids in potential immunosuppression presenting as an increased rate of infection acquisition, infectious complications and mortality. There is thus a critical need for a consensus in this area. METHODS AND ANALYSIS The methodology is based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, the MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies and the Cochrane Handbook for Systematic Reviews of Interventions. We plan to systematically search Ovid MEDLINE, CINAHL, PsycINFO, EMB Review, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Google Scholar databases from their inception date to December 2023. Full-text primary studies that report measurable outcomes in adults with chronic pain, all routes of opioid use, all types of infections and all settings will be included. We will identify a scope of reported infections and the evidence on the association of opioid use (including specific opioid, dosage, formulation and duration of use) with the risk of negative infectious outcomes. Opioid use-associated outcomes, comparing opioid use with another opioid or a non-opioid medication, will be reported. The meta-analysis will incorporate individual risk factors. If data are insufficient, the results will be synthesised narratively. Publication bias and confounding evaluation will be performed. The Grading of Recommendations Assessment, Development and Evaluation framework will be used. ETHICS AND DISSEMINATION Approval for the use of published data is not required. The results will be published, presented at conferences and discussed in deliberative dialogue groups. PROSPERO REGISTRATION NUMBER CRD42023402812.
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Affiliation(s)
- Irina Kudrina
- Faculty of Medicine and Health Sciences, Family Medicine Department, McGill University, Montreal, Québec, Canada
- Alan Edwards Pain Management Unit, Anesthesia Department, Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
- Division of Secondary Care, Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
- BRAiN & neurosciences, Research Institute, McGill University Health Centre, Montreal, Québec, Canada
| | - M Gaberielle Page
- Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Université de Montréal, Montreal, Québec, Canada
- Canada Research center, Centre hospitalier de l’Université de Montréal, Montreal, Québec, Canada
| | - Manon Choinière
- Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Université de Montréal, Montreal, Québec, Canada
- Canada Research center, Centre hospitalier de l’Université de Montréal, Montreal, Québec, Canada
| | - Yoram Shir
- Alan Edwards Pain Management Unit, Anesthesia Department, Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
| | - Mark J Eisenberg
- Center for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada
- Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
- Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Québec, Canada
- Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Québec, Canada
| | - Maayan Ben-Sasson
- Alan Edwards Pain Management Unit, Anesthesia Department, Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
| | - Bertrand Lebouché
- Faculty of Medicine and Health Sciences, Family Medicine Department, McGill University, Montreal, Québec, Canada
- Division of Secondary Care, Faculty of Medicine and Health Sciences, McGill University, Montreal, Québec, Canada
- Centre for Outcomes Research & Evaluation, Research Institute of the McGill University Health Centre, Montreal, Québec, Canada
- Chronic Viral Illness Service, Division of Infectious Disease, Department of Medicine, McGill University Health Centre, Montreal, Québec, Canada
| | - Svetlana Puzhko
- Department of General Practice and Family Medicine, University of Bielefeld, Bielefeld, Germany
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Hegde Y, Hayney MS, Caldera F. Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab. ACG Case Rep J 2024; 11:e01507. [PMID: 39866528 PMCID: PMC11759320 DOI: 10.14309/crj.0000000000001507] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/15/2024] [Accepted: 08/12/2024] [Indexed: 01/28/2025] Open
Abstract
Patients with inflammatory bowel disease who receive immunosuppressive therapy have an increased risk of infection. Live vaccines are contraindicated in these patients because of the increased risk of unchecked replication of the attenuated vaccine microorganisms. Vedolizumab is a gut-selective biological agent with a low risk of infection approved for the treatment of inflammatory bowel disease. There are limited data on the risk of providing a live vaccine in patients receiving vedolizumab, and patients may receive live vaccines if the benefits outweigh the risks. We describe a patient with ulcerative colitis, treated with vedolizumab who received 2 live vaccines, typhoid and yellow fever, without postimmunization adverse events.
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Affiliation(s)
- Yash Hegde
- Department of Medicine, School of Medicine & Public Health, University of Wisconsin—Madison, Madison, WI
| | - Mary S. Hayney
- School of Pharmacy, School of Medicine & Public Health, University of Wisconsin--Madison, Madison, WI
| | - Freddy Caldera
- Department of Medicine, Division of Gastroenterology and Hepatology, School of Medicine & Public Health, University of Wisconsin—Madison, Madison, WI
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Nucera E, Urbani S, Aruanno A, Scaldaferri F, D'Urso D, De Simone C. Adult-onset atopic dermatitis induced by vedolizumab: a case series. Postepy Dermatol Alergol 2024; 41:542-544. [PMID: 39606602 PMCID: PMC11589640 DOI: 10.5114/ada.2024.144405] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2024] [Accepted: 03/05/2024] [Indexed: 11/29/2024] Open
Affiliation(s)
- Eleonora Nucera
- Allergy Unit of "Fondazione Policlinico Universitario A.Gemelli IRCCS", Rome, Italy
| | - Sara Urbani
- Allergy Unit of "Fondazione Policlinico Universitario A.Gemelli IRCCS", Rome, Italy
| | - Arianna Aruanno
- Allergy Unit of "Fondazione Policlinico Universitario A.Gemelli IRCCS", Rome, Italy
| | - Franco Scaldaferri
- Digestive Disease Center, Medical and Surgical Sciences Department, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Dario D'Urso
- Dermatology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Clara De Simone
- Dermatology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
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Holmer AK, Hudesman D. Positioning Crohn's Disease Therapies in the Era of Small Molecules and Combination Therapies. Curr Gastroenterol Rep 2024; 26:263-272. [PMID: 38970743 DOI: 10.1007/s11894-024-00937-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/24/2024] [Indexed: 07/08/2024]
Affiliation(s)
- Ariela K Holmer
- Inflammatory Bowel Disease Center, Division of Gastroenterology, NYU Langone Health, 240 East 38Th Street, 23Rd Floor, New York, NY, 10016, USA
| | - David Hudesman
- Inflammatory Bowel Disease Center, Division of Gastroenterology, NYU Langone Health, 240 East 38Th Street, 23Rd Floor, New York, NY, 10016, USA.
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Singh A, Khanna T, Mahendru D, Kahlon J, Kumar V, Sohal A, Yang J. Insights into renal and urological complications of inflammatory bowel disease. World J Nephrol 2024; 13:96574. [PMID: 39351187 PMCID: PMC11439091 DOI: 10.5527/wjn.v13.i3.96574] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Revised: 07/01/2024] [Accepted: 07/15/2024] [Indexed: 09/19/2024] Open
Abstract
Inflammatory bowel disease (IBD) is a chronic condition characterized by immune-mediated inflammation in the gastrointestinal tract, which follows a relapsing and remitting course. Apart from affecting the gastrointestinal tract, IBD also has extra-intestinal manifestations (EIMs). While the etiology of extraintestinal manifestation remains unclear, it is theorized to be based on immunological responses influenced by genetic factors. Renal involvement is one of the EIMs observed in ulcerative colitis and Crohn's disease. The renal manifestations in IBD patients encompass a range of conditions including nephrolithiasis, amyloidosis, tubulointerstitial nephritis, glomerulonephritis (GN), obstructive pathologies, and chronic kidney disease (CKD). The incidence of CKD in IBD patients varies from 5%-15%. The decline in renal function can stem from various factors such as direct inflammatory damage to the kidneys leading to glomerular or tubular injury, or from complications like recurrent stones, amyloidosis, or GN. Additionally, nephrotoxic medications used in treating IBD, such as TNF-α inhibitors, calcineurin inhibitors, and aminosalicylates, can exacerbate the decline in renal function. Currently, there is a lack of consensus regarding these patients' screening and renal function monitoring. This review aims to assess the existing literature on the different renal complications among individuals with IBD, shedding light on their pathophysiology and management.
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Affiliation(s)
- Anmol Singh
- Department of Medicine, Tristar Centennial Medical Center, Nashville, TN 37203, United States
| | - Tejasvini Khanna
- Department of Medicine, Maulana Azad Medical College, New Delhi 110002, India
| | - Diksha Mahendru
- Department of Medicine, Dayanand Medical College and Hospital, Ludhiana 141001, Punjab, India
| | - Jasraj Kahlon
- Department of Internal Medicine, Abrazo Medical Center, Phoenix, AZ 85015, United States
| | - Vikash Kumar
- Department of Medicine, The Brooklyn Hospital Center, Brooklyn, NY 11201, United States
| | - Aalam Sohal
- Department of Hepatology, Liver Institute Northwest, Seattle, WA 98105, United States
| | - Juliana Yang
- Division of Gastroenterology and Hepatology, University of Texas Medical Branch, Galveston, TX 77555, United States
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Sharma N, Tewatia P, Harvey PR, Kumar A. Controversies in Venous Thromboembolism Risk Assessment in Inflammatory Bowel Disease: A Narrative Review. Diagnostics (Basel) 2024; 14:2112. [PMID: 39410515 PMCID: PMC11476391 DOI: 10.3390/diagnostics14192112] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2024] [Revised: 09/10/2024] [Accepted: 09/20/2024] [Indexed: 10/20/2024] Open
Abstract
Inflammatory bowel disease (IBD) is a chronic inflammatory condition affecting the gastrointestinal tract with increasing rates of incidence and prevalence across the world. Complex inflammatory and prothrombotic pathophysiology in IBD makes venous thromboembolism (VTE) a common complication with significant morbidity and mortality. This risk is increased in pregnancy. As we continue to understand the pathogenesis of IBD, this article highlights the continued risk of VTE following discharge, for which there is currently no clear guidance, yet the risk of VTE remains high. Furthermore, we discuss this increased VTE risk in the context of pregnant IBD patients and the relevant current guidelines. Alongside this, medications that are used to manage IBD carry their own thrombotic risk, which clinicians should be aware of. Assessing VTE risks in IBD populations using newer medications should be a focus of future research.
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Affiliation(s)
| | | | - Philip R. Harvey
- Department of Gastroenterology, The Royal Wolverhampton NHS Trust, Wolverhampton WV10 0QP, UK; (N.S.); (P.T.); (A.K.)
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Maier JA, Castiglioni S, Petrelli A, Cannatelli R, Ferretti F, Pellegrino G, Sarzi Puttini P, Fiorina P, Ardizzone S. Immune-Mediated Inflammatory Diseases and Cancer - a dangerous liaison. Front Immunol 2024; 15:1436581. [PMID: 39359726 PMCID: PMC11445042 DOI: 10.3389/fimmu.2024.1436581] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Accepted: 08/29/2024] [Indexed: 10/04/2024] Open
Abstract
Patients with Immune-Mediated Inflammatory Diseases (IMIDs) are known to have an elevated risk of developing cancer, but the exact causative factors remain subject to ongoing debate. This narrative review aims to present the available evidence concerning the intricate relationship between these two conditions. Environmental influences and genetic predisposition lead to a dysregulated immune response resulting in chronic inflammation, which is crucial in the pathogenesis of IMIDs and oncogenic processes. Mechanisms such as the inflammatory microenvironment, aberrant intercellular communication due to abnormal cytokine levels, excessive reparative responses, and pathological angiogenesis are involved. The chronic immunosuppression resulting from IMIDs treatments further adds to the complexity of the pathogenic scenario. In conclusion, this review highlights critical gaps in the current literature, suggesting potential avenues for future research. The intricate interplay between IMIDs and cancer necessitates more investigation to deepen our understanding and improve patient management.
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Affiliation(s)
- Jeanette A Maier
- Department of Biomedical and Clinical Sciences, Università di Milano, Milano, Italy
| | - Sara Castiglioni
- Department of Biomedical and Clinical Sciences, Università di Milano, Milano, Italy
| | - Alessandra Petrelli
- Department of Clinical Sciences and Community Health, University of Milan, Milano, Italy
| | | | | | | | - Piercarlo Sarzi Puttini
- Department of Biomedical and Clinical Sciences, Università di Milano, Milano, Italy
- IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milano, Italy
| | - Paolo Fiorina
- Department of Biomedical and Clinical Sciences, Università di Milano, Milano, Italy
| | - Sandro Ardizzone
- Gastroenterology Unit, ASST Fatebenefratelli-Sacco, Milano, Italy
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Ni Y, Huang M, Chen S, Wang S, Chen J. Integrins and NAFLD-associated liver diseases: clinical associations, pathophysiological mechanisms and pharmacological implications. Acta Biochim Biophys Sin (Shanghai) 2024; 56:1573-1583. [PMID: 40384047 PMCID: PMC11659783 DOI: 10.3724/abbs.2024149] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2024] [Accepted: 05/23/2024] [Indexed: 05/20/2025] Open
Abstract
Nonalcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease and poses a substantial health burden with increasing incidence globally. NAFLD encompasses a spectrum extending from hepatic steatosis to nonalcoholic steatohepatitis (NASH), with the possibility of progressing to cirrhosis or, in severe instances, hepatocellular carcinoma (HCC). NAFLD extends beyond simple metabolic disruption and involves multiple immune cell-mediated inflammatory processes. Integrins are a family of heterodimeric transmembrane cell adhesion receptors that regulate various aspects of NAFLD onset and progression, including hepatocellular steatosis, hepatic stellate cell (HSC) activation and immune cell infiltration. In this review, we comprehensively summarize the involvement of integrins in NAFLD, as well as the downstream signal transduction mediated by these receptors. Furthermore, we present the latest clinical and preclinical findings on drugs that target integrins for steatosis, inflammation, fibrosis and NAFLD-related HCC treatment.
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Affiliation(s)
- Yangyue Ni
- Key Laboratory of Systems Health Science of Zhejiang ProvinceSchool of Life ScienceHangzhou Institute for Advanced StudyUniversity of Chinese Academy of SciencesHangzhou310024China
- Key Laboratory of Multi-Cell SystemsShanghai Institute of Biochemistry and Cell BiologyCenter for Excellence in Molecular Cell ScienceChinese Academy of SciencesUniversity of Chinese Academy of SciencesShanghai200031China
| | - Mengwen Huang
- Key Laboratory of Systems Health Science of Zhejiang ProvinceSchool of Life ScienceHangzhou Institute for Advanced StudyUniversity of Chinese Academy of SciencesHangzhou310024China
- Key Laboratory of Multi-Cell SystemsShanghai Institute of Biochemistry and Cell BiologyCenter for Excellence in Molecular Cell ScienceChinese Academy of SciencesUniversity of Chinese Academy of SciencesShanghai200031China
| | - Shiyang Chen
- Key Laboratory of Systems Health Science of Zhejiang ProvinceSchool of Life ScienceHangzhou Institute for Advanced StudyUniversity of Chinese Academy of SciencesHangzhou310024China
| | - Shihui Wang
- Key Laboratory of Multi-Cell SystemsShanghai Institute of Biochemistry and Cell BiologyCenter for Excellence in Molecular Cell ScienceChinese Academy of SciencesUniversity of Chinese Academy of SciencesShanghai200031China
| | - Jianfeng Chen
- Key Laboratory of Systems Health Science of Zhejiang ProvinceSchool of Life ScienceHangzhou Institute for Advanced StudyUniversity of Chinese Academy of SciencesHangzhou310024China
- Key Laboratory of Multi-Cell SystemsShanghai Institute of Biochemistry and Cell BiologyCenter for Excellence in Molecular Cell ScienceChinese Academy of SciencesUniversity of Chinese Academy of SciencesShanghai200031China
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Polat Terece S, Ertoy Karagol HI, Teker Duztas D, Koken G, Ozturk H, Yapar D, Egritas Gurkan O, Sari S, Dalgic B, Bakirtas A. Immediate Hypersensitivity Reactions to Biologic Drugs in Children with Inflammatory Bowel Diseases. Int Arch Allergy Immunol 2024; 186:142-149. [PMID: 39231451 DOI: 10.1159/000540795] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Accepted: 08/02/2024] [Indexed: 09/06/2024] Open
Abstract
INTRODUCTION The increased use of biologic drugs (BDs) may lead to an increase in immediate hypersensitivity reactions (I-HSRs) in pediatric patients with inflammatory bowel disease (IBD). Our aim was to assess I-HSRs to BDs in pediatric IBD, examining frequency, clinical features, management, and associated risk factors. METHODS All children diagnosed with IBD at our institution between January 1, 2006, and August 1, 2023, and who developed I-HSRs related to any BD were included in the study. RESULTS In a study of 197 pediatric IBD patients, 61 used BD. Among these, 52.4% were male, with a median diagnosis age of 145 months (13-215). Out of a total of 1,679 administrations, 6 patients developed I-HSRs (5 with infliximab, 1 with adalimumab), resulting in a frequency of 9.8% per patient and 0.36% per administration. Of these, 66.7% were cases of Type 1 HSRs (skin test positivity n = 1), while the rest were infusion-related reactions (anti-drug antibody positivity n = 4), all of which were mild to moderate in severity. In the age and gender-adjusted logistic regression model, the presence of any comorbid allergic disease was significantly associated with the occurrence of I-HSR (aOR = 8.35; 95% CI = 1.24-56.38; p = 0.029). CONCLUSION The frequency of I-HSRs to BDs in children with IBD is not rare but not severe in the long term. The presence of any comorbid allergic disease is a risk factor for the development of I-HSRs to BDs.
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Affiliation(s)
- Sinem Polat Terece
- Department of Pediatric Allergy, Faculty of Medicine, Gazi University, Ankara, Turkey
| | | | - Demet Teker Duztas
- Department of Pediatric Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Gizem Koken
- Department of Pediatric Allergy, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Hakan Ozturk
- Department of Pediatric Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Dilek Yapar
- Directorate of Muratpasa District Health, Antalya, Turkey
| | - Odul Egritas Gurkan
- Department of Pediatric Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Sinan Sari
- Department of Pediatric Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Buket Dalgic
- Department of Pediatric Gastroenterology, Faculty of Medicine, Gazi University, Ankara, Turkey
| | - Arzu Bakirtas
- Department of Pediatric Allergy, Faculty of Medicine, Gazi University, Ankara, Turkey
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Tariq R, Loftus EV. Home-based Biologic Infusions for Inflammatory Bowel Disease: Are We Ready for Prime Time? Inflamm Bowel Dis 2024; 30:1633-1634. [PMID: 37819733 DOI: 10.1093/ibd/izad240] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2023] [Indexed: 10/13/2023]
Affiliation(s)
- Raseen Tariq
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Edward V Loftus
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
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Schmoyer CJ, Sun K, Zack J, Kumar P, Shivashankar R. Adverse Events and Compliance Among Inflammatory Bowel Disease Patients Treated With Home- vs Office-Based Biologic Infusions. Inflamm Bowel Dis 2024; 30:1529-1535. [PMID: 37819840 DOI: 10.1093/ibd/izad226] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2023] [Indexed: 10/13/2023]
Abstract
BACKGROUND Biologic medications are a common therapy for those with inflammatory bowel disease (IBD). There are limited data on the outcomes of home-based biologic infusions for patients with IBD. The aim of this study was to compare the safety and efficacy of biologic infusions for IBD patients who receive either home- or office-based administration. METHODS Patients receiving infliximab or vedolizumab were analyzed retrospectively over a period of 152 weeks. Survival free of major adverse events including delayed infusion reaction, steroid initiation, drug discontinuation, or IBD-related emergency department visits, admission, and surgery were compared using a Kaplan-Meier curve. Individual adverse events, infusion-.related quality measures, and markers of patient adherence were analyzed. RESULTS Adverse event-free survival was greater among those receiving home-based infusion (n = 154) compared with office-based infusion (n = 133). The office infusion cohort had higher rates of delayed infusion reactions (4 vs 0), IBD-related surgery (6 vs 0), and drug discontinuation (44 vs 35); this was a sicker cohort of patients compared with those in the home infusion group. Home infusion patients were less likely to receive correct weight-based dosing for infliximab (71.7% vs 89.3%), obtain labs for drug monitoring (53.2% vs 71.4%), and adhere to routine clinic visits (37.9% vs 58.1%). CONCLUSIONS The home-based infusion of biologics for IBD appears safe with lower rates of major adverse events compared with office-based infusions. However, those receiving home infusion were less likely to receive correct weight-based dosing for infliximab and were poorly adherent to routine follow-up.
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Affiliation(s)
- Christopher J Schmoyer
- Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA
| | - Kelly Sun
- Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA, USA
| | - Jeremy Zack
- Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA, USA
| | - Priyanka Kumar
- Department of Internal Medicine, University of California, Irvine, Irvine, CA, USA
| | - Raina Shivashankar
- Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospital, Philadelphia, PA, USA
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Milioli NJ, Fernandes MV, Correa TL, Antunes V, Martins OC, Florêncio de Mesquita C, Baraldo S, Furfaro F. Vedolizumab versus ustekinumab in Crohn's disease with prior anti-tumor necrosis factor failure: an updated meta-analysis. Eur J Gastroenterol Hepatol 2024; 36:1068-1074. [PMID: 38973525 DOI: 10.1097/meg.0000000000002817] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 07/09/2024]
Abstract
Ustekinumab and vedolizumab are key treatment options for Crohn's disease patients who fail anti-tumor necrosis factor (TNF) therapy. This updated meta-analysis aims to compare the efficacy and safety of these two drugs. We performed a systematic review in PubMed, Embase , and Cochrane databases searching for randomized and nonrandomized studies comparing vedolizumab versus ustekinumab in patients with Crohn's disease with previous anti-TNF failure or intolerance. The primary outcome was steroid-free clinical remission (SFR) at the pos-induction (12-16 weeks) and maintenance period (48-52 weeks). The odds ratio (OR) was used for binary outcomes with their respective 95% confidence interval (CI). Heterogeneity was assessed using the Cochran Q test and I2 statistics. This meta-analysis included 11 studies and 2724 patients. There was a significant difference favoring ustekinumab in SFR at pos-induction (OR, 1.44; 95% CI, 1.11-1.88; P = 0.006; I2 = 27%) and maintenance periods (OR, 1.86; 95% CI, 1.23-2.82; P = 0.003; I2 = 80%), in clinical remission at pos-induction period (OR, 2.04; 95% CI, 1.58-2.63; P < 0.001; I2 = 3%), and in treatment discontinuation due to adverse events (OR, 0.31; 95% CI, 0.16-0.60; P < 0.001; I2 = 0%). In patients with Crohn's disease with prior anti-TNF failure, ustekinumab showed higher SFR during both the pos-induction and maintenance period and a lower rate of treatment discontinuation due to adverse events.
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Affiliation(s)
- Natália Junkes Milioli
- Department of Gastroenterology and Gastrointestinal Endoscopy, Pontifical Catholic University of Rio Grande do Sul
| | - Matheus Vanzin Fernandes
- Department of Gastroenterology and Gastrointestinal Endoscopy, Porto Alegre Health Science's Federal University, Porto Alegre, Brazil
| | - Tulio L Correa
- Department of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Vanio Antunes
- Department of Gastroenterology and Gastrointestinal Endoscopy, Porto Alegre Health Science's Federal University, Porto Alegre, Brazil
| | | | | | - Stefano Baraldo
- Department of Endoscopy, Barretos Cancer Hospital, Barretos, Brazil
| | - Federica Furfaro
- Department of Gastroenterology and Gastrointestinal Endoscopy, IRCCS San Raffaele Scientific Institute, Milan, Italy
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Kim KO, Lee SH. [Old and New Biologics and Small Molecules in Inflammatory Bowel Disease: Anti Integrins]. THE KOREAN JOURNAL OF GASTROENTEROLOGY = TAEHAN SOHWAGI HAKHOE CHI 2024; 84:43-50. [PMID: 39176460 DOI: 10.4166/kjg.2024.070] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/06/2024] [Revised: 08/04/2024] [Accepted: 08/12/2024] [Indexed: 08/24/2024]
Abstract
Recently, novel biologics or small molecular drugs have been introduced for overcoming the unmet needs associated with anti-tumor necrosis factor α agents for inflammtory bowel disease (IBD) treatment. Among these novel drugs, anti integrin agents block leukocyte trafficking to the intestine by blocking the interaction between integrin and cell adhesion molecules. Vedolizumab (anti-α4β7) is most widely used anti-integrin approved in both ulcerative colitis and Crohn's disease .It has been shown to be effective in both induction and maintenance therapy with a favorable safety profile due to gut selectivity. Several models incorporating clinical, genetic, immune and gut microbial markers to predict response to vedolizumab in IBD have been developed. Etrolizumab (anti-β7) blocks leukocyte trafficking via α4β7 and cell adhesion via αEβ7 integrins. In addition, the introduction of subcutaneous vedolizumab showed similar efficacy and safety with improved patients' convenience. Other investigational anti-integrin therapies include abrilumab (anti-α4β7 IgG2), PN-943 (orally administered and gut-restricted α4β7 antagonist peptide), AJM300 (orally active small molecule inhibitor of α4), and ontamalimab (anti-MAdCAM-1 IgG).
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Affiliation(s)
- Kyeong Ok Kim
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Si Hyung Lee
- Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
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Faggiani I, Fanizza J, D’Amico F, Allocca M, Zilli A, Parigi TL, Barchi A, Danese S, Furfaro F. Extraintestinal Manifestations in Inflammatory Bowel Disease: From Pathophysiology to Treatment. Biomedicines 2024; 12:1839. [PMID: 39200303 PMCID: PMC11351332 DOI: 10.3390/biomedicines12081839] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2024] [Revised: 08/02/2024] [Accepted: 08/09/2024] [Indexed: 09/02/2024] Open
Abstract
The inflammatory bowel diseases (IBDs) are systemic conditions that affect not only the gastrointestinal tract but also other parts of the body. The presence of extraintestinal manifestations can significantly impact the quality of life in IBD patients. Peripheral arthritis, episcleritis, and erythema nodosum are frequently associated with active intestinal inflammation and often improve with standard treatment targeting intestinal inflammation. In contrast, anterior uveitis, ankylosing spondylitis, and primary sclerosing cholangitis typically occur independently of disease flares. The incidence of these conditions in individuals with IBD can reach up to 50% of patients over the course of their lifetime. In addition, some advanced therapies utilized for the treatment of IBD potentially result in side effects that may resemble extraintestinal manifestations. This review provides a thorough analysis of the pathophysiology and treatment of extraintestinal manifestations associated with Crohn's disease and ulcerative colitis.
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Affiliation(s)
- Ilaria Faggiani
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
- Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, 20132 Milan, Italy
| | - Jacopo Fanizza
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
- Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, 20132 Milan, Italy
| | - Ferdinando D’Amico
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
| | - Mariangela Allocca
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
| | - Alessandra Zilli
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
| | - Tommaso Lorenzo Parigi
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
- Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, 20132 Milan, Italy
| | - Alberto Barchi
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
- Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, 20132 Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
- Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, 20132 Milan, Italy
| | - Federica Furfaro
- Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital, 20132 Milan, Italy; (I.F.); (J.F.); (F.D.); (M.A.); (A.Z.); (T.L.P.); (S.D.); (F.F.)
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Yarur AJ, Bressler B, Brett NR, Bassel M, Adsul S, Kamble P, Mantzaris GJ. Real-world Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-naive Patients With Crohn's Disease: Results From the EVOLVE Study. J Clin Gastroenterol 2024:00004836-990000000-00334. [PMID: 39102457 DOI: 10.1097/mcg.0000000000002056] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2024] [Accepted: 06/21/2024] [Indexed: 08/07/2024]
Abstract
GOALS This study evaluated the real-world effectiveness and safety of vedolizumab versus adalimumab over 12 months of treatment in biologic-naive patients with Crohn's disease (CD), using data from the EVOLVE study. BACKGROUND A comparison of vedolizumab and adalimumab may help to better position them in the therapeutic algorithm for moderate-to-severe CD. STUDY Data were collected from medical records of patients with CD aged ≥18 years initiating treatment with adalimumab or vedolizumab between May 2014 and July 2017. Adjusted analyses were performed using inverse probability weighting to account for differences in baseline characteristics. Cumulative rates for clinical effectiveness outcomes and treatment persistence were estimated using Kaplan-Meier analyses. Disease-related exacerbations, serious adverse events (SAEs), and serious infections (SIs) were also assessed. RESULTS Data from 218 vedolizumab- and 144 adalimumab-treated patients were analyzed. Adjusted cumulative rates of clinical remission were greater with vedolizumab than with adalimumab (66.3% vs. 46.4%; P=0.006). Probability of treatment persistence was higher with vedolizumab (89.3% vs. 77.5%; P=0.024); probabilities of clinical response (68.5% vs. 61.1%; P=0.586) and mucosal healing (67.7% vs. 56.0%; P=0.562) were similar. SAEs were less likely to occur with vedolizumab [hazard ratio, 0.45 (95% confidence interval, 0.22-0.93)]; however, the likelihood of SIs [0.27 (0.06-1.20)], CD exacerbations [0.91 (0.56-1.47)], and CD-related surgeries [1.55 (0.21-11.15)] was comparable between the 2 groups. CONCLUSIONS In a real-world setting, biologic-naive patients with CD treated with vedolizumab demonstrated a greater likelihood of drug persistence and achieving clinical remission, with equivalent rates of response and mucosal healing versus adalimumab-treated patients.
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Affiliation(s)
| | | | - Neil R Brett
- PPD, part of Thermo Fisher Scientific, Montreal, QC, Canada
| | | | - Shashi Adsul
- Takeda Pharmaceuticals International AG, Zurich, Switzerland
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Lim SH, Gros B, Sharma E, Lehmann A, Lindsay JO, Caulfield L, Gaya DR, Taylor J, Limdi J, Kwok J, Shuttleworth E, Dhar A, Burdge G, Selinger C, Cococcia S, Murray C, Balendran K, Raine T, George B, Walker G, Aldridge R, Irving P, Lees CW, Samaan M. Safety, Effectiveness, and Treatment Persistence of Subcutaneous Vedolizumab in IBD: A Multicenter Study From the United Kingdom. Inflamm Bowel Dis 2024; 30:1284-1294. [PMID: 37603730 DOI: 10.1093/ibd/izad166] [Citation(s) in RCA: 8] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2022] [Indexed: 08/23/2023]
Abstract
BACKGROUND AND AIMS Despite intravenous (IV) vedolizumab being established for treatment of inflammatory bowel disease (IBD), the novel subcutaneous (SC) route of administration may provide numerous incentives to switch. However, large-scale real-world data regarding the long-term safety and effectiveness of this strategy are lacking. METHODS IBD patients on IV vedolizumab across 11 UK sites agreed to transition to SC injections or otherwise continued IV treatment. Data regarding clinical disease activity (Simple Clinical Colitis Activity Index, partial Mayo score, and modified Harvey-Bradshaw Index), biochemical markers (C-reactive protein and calprotectin), quality of life (IBD control), adverse events, treatment persistence, and disease-related outcomes (namely corticosteroid use, IBD-related hospitalization, and IBD-related surgery) were retrospectively collected from prospectively maintained clinical records at baseline and weeks 8, 24, and 52. RESULTS Data from 563 patients (187 [33.2%] Crohn's disease, 376 [66.8%] ulcerative colitis; 410 [72.8%] SC, 153 [27.2%] IV) demonstrated no differences in disease activity, remission rates, and quality of life between the SC and IV groups at all time points. Drug persistence at week 52 was similar (81.1% vs 81.2%; P = .98), as were rates of treatment alteration due to either active disease (12.2% vs 8.9%; P = .38) or adverse events (3.3% vs 6.3%; P = .41). At week 52, there were equivalent rates of adverse events (9.8% vs 7.8%; P = .572) and disease-related outcomes. IBD control scores were equivalent in both IV-IV and IV-SC groups. CONCLUSIONS Switching to SC vedolizumab appears as effective, safe, and well tolerated as continued IV treatment and maintains comparable disease control and quality of life as IV treatment at 52 weeks.
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Affiliation(s)
- Samuel Hsiang Lim
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
| | - Beatriz Gros
- Edinburgh IBD Unit, NHS Lothian, Edinburgh, United Kingdom
| | - Esha Sharma
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
| | - Anouk Lehmann
- Department of Gastroenterology, Royal London Hospital, Bart's Health NHS Trust, London, United Kingdom
| | - James O Lindsay
- Department of Gastroenterology, Royal London Hospital, Bart's Health NHS Trust, London, United Kingdom
| | - Louise Caulfield
- Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, United Kingdom
| | - Daniel R Gaya
- Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, United Kingdom
| | - Jo Taylor
- Department of Gastroenterology, Northern Care Alliance NHS Foundation Trust, Greater Manchester, United Kingdom
| | - Jimmy Limdi
- Department of Gastroenterology, Northern Care Alliance NHS Foundation Trust, Greater Manchester, United Kingdom
| | - Jon Kwok
- Department of Gastroenterology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, United Kingdom
| | - Elinor Shuttleworth
- Department of Gastroenterology, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, United Kingdom
| | - Anjan Dhar
- Department of Gastroenterology, Country Durham and Darlington NHS Foundation Trust, United Kingdom
| | - Gemma Burdge
- Department of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
| | - Christian Selinger
- Department of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
| | - Sara Cococcia
- Department of Gastroenterology, Royal Free London NHS Foundation Trust, London, United Kingdom
| | - Charles Murray
- Department of Gastroenterology, Royal Free London NHS Foundation Trust, London, United Kingdom
| | - Karthiha Balendran
- Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
| | - Tim Raine
- Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
| | - Becky George
- Department of Gastroenterology, Torbay and South Devon NHS Foundation Trust, Torquay, United Kingdom
| | - Gareth Walker
- Department of Gastroenterology, Torbay and South Devon NHS Foundation Trust, Torquay, United Kingdom
| | - Robin Aldridge
- Department of Gastroenterology, Torbay and South Devon NHS Foundation Trust, Torquay, United Kingdom
| | - Peter Irving
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
| | - Charlie W Lees
- Edinburgh IBD Unit, NHS Lothian, Edinburgh, United Kingdom
- Centre for Genomic and Experimental Medicine, University of Edinburgh, Edinburgh, United Kingdom
| | - Mark Samaan
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
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Maeda T, Connolly M, Thevenet-Morrison K, Levy P, Utell M, Munsiff S, Croft D. Tuberculosis screening for patients on biologic Medications: A Single-Center experience and Society guideline Review, Monroe County, New York, 2018-2021. J Clin Tuberc Other Mycobact Dis 2024; 36:100460. [PMID: 39021381 PMCID: PMC11254483 DOI: 10.1016/j.jctube.2024.100460] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/20/2024] Open
Abstract
Rationale Biologic medications for immune-mediated inflammatory diseases may increase the risk of tuberculosis (TB) reactivation, but data on screening for TB in low TB prevalence areas are limited. Objective To assess the real-world practice patterns of TB screening among prescribers of biologic medications. Methods We conducted a retrospective observational study at a single, university-based healthcare facility in a low TB prevalence area. We enrolled adult patients prescribed a biologic medication between October 2018 and December 2021, and collected data on demographics, biologic medications and TB test results. For patients with positive TB tests, further data including prescriber specialty and response to positive tests were obtained. We reviewed pertinent major society guidelines/ consensus statements regarding TB screening among patients treated with biologic medications. Results 4,085 patients were included. 3024 (74.0%) had at least one screening TB test and 42 were positive. Among patients treated with tumor necrosis factor-alpha (TNFα) inhibitors, 1779 of 2129 patients (83.6%) underwent TB testing and 25 (1.4%) were positive. Most with positive TB test results were prescribed biologic medication by gastroenterology (11 patients, 26%), dermatology (12, 29%), or rheumatology (15, 36%) providers. 32 (76%) patients had imaging and roughly half were treated for latent TB infection. Biologic medications were temporarily held for 27 patients (67%). Nine out of 13 society guidelines recommend TB screening for TNFα inhibitors but have differing recommendations for other biologic medications. Conclusions Significant practice pattern differences in TB screening for patients receiving biologic medications exist. Multiple society guidelines continue to recommend TB screening even for drugs with no known increased risk of TB reactivation.
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Affiliation(s)
- Tetsuro Maeda
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
| | - Margaret Connolly
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
| | - Kelly Thevenet-Morrison
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
| | - Paul Levy
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
| | - Mark Utell
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
| | - Sonal Munsiff
- Division of Infectious Diseases, University of Rochester Medical Center, United States
| | - Daniel Croft
- Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, United States
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50
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Kajikawa G, Sawada T, Nakamura M, Yamamura T, Maeda K, Ishikawa E, Uetsuki K, Hirose T, Iida T, Mizutani Y, Yamao K, Ishikawa T, Furukawa K, Kawashima H. Predictors of the efficacy of vedolizumab in patients with ulcerative colitis. NAGOYA JOURNAL OF MEDICAL SCIENCE 2024; 86:407-421. [PMID: 39355361 PMCID: PMC11439607 DOI: 10.18999/nagjms.86.3.407] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/15/2023] [Accepted: 12/08/2023] [Indexed: 10/03/2024]
Abstract
Vedolizumab is a treatment option for ulcerative colitis but data on predictors of treatment response remain insufficient to establish personalized treatment strategies. We aimed to investigate the real-world effectiveness of vedolizumab in adult patients with ulcerative colitis and explore factors involved in predicting treatment response. This single-center, single-arm, prospective observational study included 26 patients with clinically active ulcerative colitis patients' characteristics at baseline, epidemiological information, existing treatment, clinical activity index score, endoscopic score, and blood test data were collected. Serum levels of tumor necrosis factors alpha, interferon gamma, interleukin-4, interleukin-6, interleukin-10, interleukin-17, soluble mucosal addressin cell adhesion molecule 1, and soluble vascular cell adhesion molecule 1 were measured. Patient characteristics in the remission and non-remission groups were compared based on these parameters. Clinical remission at 6 weeks of treatment occurred in 9 (35%) of the 26 patients. At 14 weeks, clinical remission was observed in 11 patients (42%). There were no significant differences pertaining to age, sex, duration of disease, extent of disease, steroid resistance, or prior treatment with biological agents among the two groups after 14 weeks of treatment. Hemoglobin ≥ 11.5 g/dL (odds ratio, 15.0; 95% confidence interval, 1.50-149; P=0.014) and soluble mucosal addressin cell adhesion molecule 1 ≥ 765 pg/mL (odds ratio, 17.3; 95% confidence interval, 2.36-127; P=0.004) were significant factors. In conclusion, hemoglobin and serum soluble mucosal addressin cell adhesion molecule 1 levels are factors correlated with the therapeutic efficacy of vedolizumab.
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Affiliation(s)
- Go Kajikawa
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Tsunaki Sawada
- Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan
| | - Masanao Nakamura
- Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan
| | - Takeshi Yamamura
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Keiko Maeda
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Eri Ishikawa
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Kota Uetsuki
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Takashi Hirose
- Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan
| | - Tadashi Iida
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Yasuyuki Mizutani
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Kentaro Yamao
- Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan
| | - Takuya Ishikawa
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Kazuhiro Furukawa
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
| | - Hiroki Kawashima
- Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
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