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Androutsakos T, Dimitriadis K, Koutsompina ML, Vassilakis KD, Pouliakis A, Fragoulis GE. Hepatitis B reactivation in PsA patients: an SLR and meta-analysis for IL-17, IL-23 and JAK inhibitors. Rheumatology (Oxford) 2025; 64:935-942. [PMID: 39153010 DOI: 10.1093/rheumatology/keae445] [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: 05/29/2024] [Revised: 07/16/2024] [Accepted: 07/29/2024] [Indexed: 08/19/2024] Open
Abstract
OBJECTIVES HBV reactivation (HBVr) constitutes a side effect of the treatment of autoimmune rheumatic diseases. Even though HBVr risk of conventional synthetic DMARDs (csDMARDs) and anti-tumor necrosis factor (anti-TNF) agents has long been established, the risk of targeted synthetic (ts)DMARDs and anti-interleukin (anti-IL) agents remains largely unknown. METHODS We conducted a SLR (PubMed, Scopus and EMBASE) and meta-analysis to examine the HBVr risk for the following: anti-IL17, anti-IL12/23, anti-IL23 and JAK-inhibitors in patients with chronic HBV infection (HBsAg presence or detectable HBV-DNA) and in patients with prior HBV infection (HBcAb-positive and HBsAg-negative). Meta-analysis was performed using both the fixed and random effects method and was conducted using the R computing language. RESULTS Overall, our study revealed a low HBVr risk of <6% in all agents; the risk was significantly higher for people having chronic compared with those with resolved HBV (14.4% vs 5.1%, respectively P < 0.01). There was no difference among different drugs in the HBVr rates [anti-IL-17: 4% (95% CI: 1-9%), anti-IL-12/IL-23: 2% (95% CI: 0-5%), JAK-inhibitors: 4% (95% CI: 1-8%), anti-IL23: 0%]. Of note, HBVr rate reached 28% in patients with chronic HBV who did not receive anti-viral treatment. For patients with resolved hepatitis, the respective percentage was 4.7%. CONCLUSION Overall, our meta-analysis shows that patients with chronic HBV receiving anti-IL-17, anti-IL-12/23, anti-IL-23 and JAK-inhibitors have significant risk for HBVr, especially if they are not under anti-viral treatment. In contrast, resolved HBV seems to offer minor risk for HBVr even without anti-viral treatment.
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Affiliation(s)
- Theodoros Androutsakos
- Department of Pathophysiology, National and Kapodistrian University of Athens, Athens, Greece
| | - Konstantinos Dimitriadis
- Department of Clinical Therapeutics, 'Alexandra' hospital, National and Kapodistrian University of Athens, Athens, Greece
| | | | - Konstantinos D Vassilakis
- First Department of Internal Medicine, Propaedeutic Clinic, "Laiko" Hospital, National and Kapodistrian University of Athens, Athens, Greece
| | - Avraam Pouliakis
- Second Department of Pathology, National and Kapodistrian University of Athens, Athens, Greece
| | - George E Fragoulis
- First Department of Internal Medicine, Propaedeutic Clinic, "Laiko" Hospital, National and Kapodistrian University of Athens, Athens, Greece
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Yanagisawa Y, Imai S, Kizaki H, Hori S. A cross-sectional survey of hepatitis B virus screening in patients who received immunosuppressive therapy for rheumatoid arthritis in Japan. J Pharm Health Care Sci 2024; 10:18. [PMID: 38637884 PMCID: PMC11025209 DOI: 10.1186/s40780-024-00339-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2024] [Accepted: 04/15/2024] [Indexed: 04/20/2024] Open
Abstract
BACKGROUND Patients with a history of hepatitis B virus (HBV) infection who are receiving immunosuppressive therapy are at risk of HBV reactivation and disease. Therefore, HBV screening is required prior to administering antirheumatic drugs with immunosuppressive effects. This study aimed to determine the status of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and hepatitis B surface antibody (HBsAb) screening prior to the initiation of drug therapy, including new antirheumatic drugs, in patients with rheumatoid arthritis. METHODS This retrospective cross-sectional study used data from April 2014 to August 2022 from the Japanese hospital-based administrative claims database. The inclusion criteria were rheumatoid arthritis and first prescription date of antirheumatic drugs. RESULTS A total of 82,282 patients with rheumatoid arthritis who were first prescribed antirheumatic drugs between April 2016 and August 2022 were included. Of the eligible patients, 9.7% (n=7,959) were screened for all HBV (HBsAg, HBsAb, and HbcAb) within 12 months prior to the date of initial prescription. The HBsAg test was performed in 30.0% (n=24,700), HBsAb test in 11.8% (n=9,717), and HBcAb test in 13.1% (n=10,824) of patients. The proportion of patients screened for HBV infection has been increasing since 2018; however, the proportion of patients screened for rheumatoid arthritis remains low. CONCLUSIONS Our findings suggest that HBV screening may be insufficient in patients who received antirheumatic drugs. With the increasing use of new immunosuppressive antirheumatic drugs, including biological agents, healthcare providers should understand the risk of HBV reactivation and conduct appropriate screening.
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Affiliation(s)
- Yuki Yanagisawa
- Division of Drug Informatics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan
| | - Shungo Imai
- Division of Drug Informatics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
| | - Hayato Kizaki
- Division of Drug Informatics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan
| | - Satoko Hori
- Division of Drug Informatics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan
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Al-Homood IA, Al Ghanim N, Fatani MIA, Hussein AH, Alolaiwi AM, Abualiat A, Alqurtas E, Alomari BAA, Khardaly AM, Alenzi KAO, Albarakati RG, Almudaiheem HY, Al-Jedai A, Eshmawi MTY. The Saudi consensus recommendations for the management of psoriatic arthritis (2023). Clin Rheumatol 2024; 43:879-894. [PMID: 38217738 PMCID: PMC10876726 DOI: 10.1007/s10067-024-06867-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2023] [Revised: 12/25/2023] [Accepted: 01/02/2024] [Indexed: 01/15/2024]
Abstract
Psoriatic arthritis (PsA) is a complex inflammatory disease characterized by musculoskeletal and non-musculoskeletal manifestations. It is a distinct disease entity at the interface between rheumatology and dermatology, making it challenging to manage. The diverse clinical presentation and severity of PsA require a multidisciplinary approach for optimal care. Early diagnosis and management are necessary to improving quality of life for patients. In Saudi Arabia, there is currently no unified national consensus on the best practices for managing PsA. This lack of consensus leads to debate and uncertainty in the treatment of the disease, resulting in over or under prescribing of biological agents. To address this issue, a multidisciplinary work group was formed by the Saudi Ministry of Health. This group, consisting of dermatologists, rheumatologists, and pharmacists, aimed to develop evidence-based consensus recommendations for he use and monitoring of biological therapy in PsA management. The work group conducted five consensus workshops between December 2021 to March 2022. Using the nominal group technique, they discussed various aspects of PsA management, including eligibility criteria for biological treatment, monitoring of disease activity, treatment goals, screening, precautions, and management of PsA with biologic therapies. The group also considered special considerations for patients with comorbidities, pregnant and lactating women, as well as pediatric and adolescent populations. The resulting consensus document provides recommendations that are applicable to the Saudi setting, taking into account international guidelines and the specific needs of PsA patients in the country. The consensus document will be regularly updated to incorporate new data and therapeutic agents as they become available. Key Points • In Saudi Arabia, there is a lack of unified national consensus on the optimal management of PsA, therefore, this article aims to provide up-to-date evidence-based consensus recommendations for the optimal use and monitoring of biologic therapy in the management of PsA in Saudi Arabia. • The consensus development process was undertaken by a multidisciplinary work group of 13 experts, including two dermatologists, six rheumatologists, and five pharmacists. • There is more than one disease activity tool used in PsA disease, depending on the disease domain - peripheral arthritis Disease Activity Index in Psoriatic Arthritis (DAPSA) or Minimal Disease Activity (MDA), axial PsA Ankylosing Spondylitis Disease Activity Score (ASDAS), and dactylitis and enthesitis MDA. • The main goal of therapy in all patients with PsA is to achieve the target of remission, or alternatively, low disease activity in all disease domains and improve quality of life (QoL).
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Affiliation(s)
- Ibrahim Abdulrazag Al-Homood
- Medical Specialties Department, Rheumatology Section, King Fahad Medical City, Riyadh, Saudi Arabia.
- College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
| | - Nayef Al Ghanim
- Department of Internal Medicine, Rheumatology Unit, King Saud Medical City, Riyadh, Saudi Arabia
| | | | - Albader Hamza Hussein
- Department of Rheumatology, King Fahad General Hospital, Ministry of Health, Madinah, Saudi Arabia
| | - Abdulaziz Mohammed Alolaiwi
- Department of Rheumatology, King Saud Medical City, Riyadh, Saudi Arabia
- Deputyship of Therapeutic Affairs, Ministry of Health, Riyadh, Saudi Arabia
| | - Abdullah Abualiat
- Department of Dermatology and Venereology, Armed Forces Hospitals-Southern Region (AFHSR), Khamis Mushait, Saudi Arabia
| | - Eman Alqurtas
- Department of Medicine, College of Medicine, Rheumatology Unit, King Saud University, Riyadh, Saudi Arabia
| | | | | | | | - Rayan G Albarakati
- Department of Obstetrics and Gynecology, Majmaah University, Al-Majmaah, 11952, Saudi Arabia
| | | | - Ahmed Al-Jedai
- Deputyship of Therapeutic Affairs, Ministry of Health, Riyadh, Saudi Arabia
- College of Medicine and College of Pharmacy, Alfaisal University, Riyadh, Saudi Arabia
| | - Maysa Tariq Yousef Eshmawi
- Department of Dermatology, King Abdullah Medical Complex, Jeddah, Saudi Arabia
- College of Medicine, Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
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Patel A, Dossaji Z, Gupta K, Roma K, Chandler TM, Minacapelli CD, Catalano K, Gish R, Rustgi V. The Epidemiology, Transmission, Genotypes, Replication, Serologic and Nucleic Acid Testing, Immunotolerance, and Reactivation of Hepatitis B Virus. GASTRO HEP ADVANCES 2023; 3:139-150. [PMID: 39129942 PMCID: PMC11307719 DOI: 10.1016/j.gastha.2023.10.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 03/31/2023] [Accepted: 10/18/2023] [Indexed: 08/13/2024]
Abstract
The epidemiology of Hepatitis B virus (HBV) has drastically changed in recent decades due to public health initiatives, including universal infant vaccination programs,urbanization driving global travel, and migration patterns. Despite screening of pregnant women and newborns significantly reducing the rate of perinatal transmission in certain parts of the world, other, perhaps more uncommon, routes (e.g., parenteral) have led to outbreaks in specific areas affected by the opioid epidemic and injection drug use. Although our current understanding of the effect of genetic variants of HBV is lacking, we review current knowledge and patterns of genetic variants with geographical predominance, pathophysiology, and clinical manifestations. Serologic and molecular markers are used to screen, identify phase and activity of infection, and monitor response to antivirals and/or reactivation. This review will provide the most up-to-date summary of the epidemiology, transmission, genotype, replication, and current methods of screening to follow the various phases of HBV, including immunotolerance and reactivation.
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Affiliation(s)
- Ankoor Patel
- Internal Medicine, Robert Wood Johnson Medical School, Rutgers Biomedical and Health Sciences (RBHS), Rutgers University, New Brunswick, New Jersey
- Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
| | - Zahra Dossaji
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, Nevada
| | - Kapil Gupta
- Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
| | - Katerina Roma
- Internal Medicine, Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas, Nevada
| | - Toni-Marie Chandler
- Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
| | - Carlos D. Minacapelli
- Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
- Center for Liver Diseases and Masses, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
| | - Kaitlyn Catalano
- Center for Liver Diseases and Masses, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
| | - Robert Gish
- Hepatitis B Foundation, Doylestown, Pennsylvania
| | - Vinod Rustgi
- Division of Gastroenterology and Hepatology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
- Center for Liver Diseases and Masses, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
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Katelani S, Fragoulis GE, Bakasis AD, Pouliakis A, Nikiphorou E, Atzeni F, Androutsakos T. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: a systematic review and meta-analysis. Rheumatology (Oxford) 2023; 62:SI252-SI259. [PMID: 37871924 DOI: 10.1093/rheumatology/kead243] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2023] [Accepted: 04/23/2023] [Indexed: 10/25/2023] Open
Abstract
OBJECTIVE The objective of this study was to assess the possibility of HBV reactivation (HBVr) in patients with RA under anti-IL-6 treatment. METHODS Using PubMed, Scopus and EMBASE, we performed a systematic literature search for articles related to HBVr in RA patients under anti-IL-6 treatment. The search was performed with no date limits and was last updated 28 January 2023. The results from all the databases were combined and duplicates were excluded, as were non-English articles, case reports, position articles, comments, and paediatric studies. RESULTS Our initial search led to 427 articles; 28 were duplicates, 46 non-English, 169 reviews, 31 books/letters, 25 case reports, and 88 irrelevant to the meta-analysis aim; 21 were excluded due to inadequate information, leaving 19 articles, with a sum of 372 RA patients with chronic HBV (CHB) or resolved HBV infection, for further analysis. The overall risk for HBVr in RA patients with CHB was 6.7%, increasing to 37% when only RA patients with CHB and no antiviral prophylaxis were included. On the contrary, HBVr was close to 0% in RA patients with resolved HBV infection, irrespective of antiviral prophylaxis. All RA patients experiencing HBVr in these studies were successfully managed with antiviral treatment and/or drug withdrawal. CONCLUSION Overall, anti-IL-6 treatment comes with a significant risk of HBVr in RA patients with CHB; risk is diminished when antiviral prophylaxis is used. In contrast, in RA patients with resolved HBV infection, the risk of HBVr seems to be extremely low. Large, well-designed studies (either controlled trials or multicentre/international observational studies) are warranted to further validate these results.
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Affiliation(s)
- Stamatia Katelani
- Department of Pathophysiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece
| | - George E Fragoulis
- First Department of Internal Medicine, Propedeutic Clinic, "Laiko" Hospital, National and Kapodistrian University of Athens, Athens, Greece
- Institute of Infection, Immunity and Inflammation, University of Glasgow, Scotland, UK
| | | | - Abraham Pouliakis
- 2nd Department of Pathology, National and Kapodistrian University of Athens, Medical School, University General Hospital Attikon, Athens, Greece
| | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King's College London, London, UK
| | - Fabiola Atzeni
- Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Messina, Italy
| | - Theodoros Androutsakos
- Department of Pathophysiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece
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Jahnich N, Arkwright PD. Regional risk of tuberculosis and viral hepatitis with tumor necrosis factor-alpha inhibitor treatment: A systematic review. Front Pharmacol 2023; 14:1046306. [PMID: 36744250 PMCID: PMC9894886 DOI: 10.3389/fphar.2023.1046306] [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: 09/16/2022] [Accepted: 01/05/2023] [Indexed: 01/21/2023] Open
Abstract
Background: TNFα inhibitors are regularly used to treat autoimmune diseases. Tuberculosis (TB) and viral hepatitis B are considered potential infectious complications, and screening and surveillance are therefore recommended. Current guidelines do not take into account regional differences in endemicity of these infections. Methods: A systematic literature review of TB and viral hepatitis in patients receiving TNFα-inhibitors was performed, searching in PubMed, Embase, MEDLINE and Web of Science databases. Studies were selected against predefined eligibility criteria and assessed using the Newcastle-Ottawa scale. The number of TB and viral hepatitis cases/1,000 TNFα-inhibitor patients were evaluated, and regional variation compared. Results: 105 observational studies involving over 140,000 patients were included. Overall, 1% of patients developed TB or viral hepatitis B. TB cases/1,000 TNFα-inhibitor patients were 4-fold higher in Asia, Africa, and South America than in Europe, North America, and Australasia where only 0%-0.4% of patients developed TB. Hepatitis B cases/1,000 patients were over 15-fold higher in countries with high prevalence (China, Taiwan, South Korea, Thailand) compared with low prevalence (p < 0.00001) where only 0.4% of patients developed hepatitis B. Only three of 143 patients developed viral hepatitis C, and there was insufficient data to allow regional sub-analysis. Conclusion: TB and viral hepatitis B infections in patients treated with TNFα inhibitors are largely confined to countries with high prevalence of these infections. As only 1/2,500 patients in low prevalence countries treated with TNFα inhibitors develop TB or viral hepatitis B, we suggest an individualized, risk-based approach, rather than universal screening for all patients.
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Affiliation(s)
| | - Peter D. Arkwright
- Lydia Becker Institute of Immunology and Inflammation, Manchester Incubator Building, University of Manchester, Manchester, United Kingdom
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Fragoulis GE, Nikiphorou E, Dey M, Zhao SS, Courvoisier DS, Arnaud L, Atzeni F, Behrens GM, Bijlsma JW, Böhm P, Constantinou CA, Garcia-Diaz S, Kapetanovic MC, Lauper K, Luís M, Morel J, Nagy G, Polverino E, van Rompay J, Sebastiani M, Strangfeld A, de Thurah A, Galloway J, Hyrich KL. 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2022; 82:742-753. [PMID: 36328476 DOI: 10.1136/ard-2022-223335] [Citation(s) in RCA: 64] [Impact Index Per Article: 21.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2022] [Accepted: 10/11/2022] [Indexed: 11/06/2022]
Abstract
ObjectivesTo develop EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in patients with autoimmune inflammatory rheumatic diseases (AIIRD).MethodsAn international Task Force (TF) (22 members/15 countries) formulated recommendations, supported by systematic literature review findings. Level of evidence and grade of recommendation were assigned for each recommendation. Level of agreement was provided anonymously by each TF member.ResultsFour overarching principles (OAP) and eight recommendations were developed. The OAPs highlight the need for infections to be discussed with patients and with other medical specialties, in accordance with national regulations. In addition to biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for which screening for latent tuberculosis (TB) should be performed, screening could be considered also before conventional synthetic DMARDs, glucocorticoids and immunosuppressants. Interferon gamma release assay should be preferred over tuberculin skin test, where available. Hepatitis B (HBV) antiviral treatment should be guided by HBV status defined prior to starting antirheumatic drugs. All patients positive for hepatitis-C-RNA should be referred for antiviral treatment. Also, patients who are non-immune to varicella zoster virus should be informed about the availability of postexposure prophylaxis should they have contact with this pathogen. Prophylaxis againstPneumocystis jiroveciiseems to be beneficial in patients treated with daily doses >15–30 mg of prednisolone or equivalent for >2–4 weeks.ConclusionsThese recommendations provide guidance on the screening and prevention of chronic and opportunistic infections. Their adoption in clinical practice is recommended to standardise and optimise care to reduce the burden of opportunistic infections in people living with AIIRD.
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Affiliation(s)
- George E Fragoulis
- Joint Academic Rheumatology Program, First Department of Propaedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece
- Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
| | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King's College London, London, UK
- Rheumatology Department, King's College London, London, UK
| | - Mrinalini Dey
- Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK
- Rheumatology Department, Countess of Chester Hospital NHS Foundation Trust, Chester, UK
| | - Sizheng Steven Zhao
- Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Science, The University of Manchester, Manchester, UK
| | | | - Laurent Arnaud
- Department of Rheumatology, National Reference Center for Autoimmune Diseases (RESO), University Hospitals Strasbourg, Strasbourg, France
| | - Fabiola Atzeni
- Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Messina, Italy
| | - Georg Mn Behrens
- Department for Rheumatology and Immunology, Hannover Medical School, Hannover, Germany
| | - Johannes Wj Bijlsma
- Dept of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
| | - Peter Böhm
- Forschungspartner, German League against rheumatism, Bonn, Germany
| | | | - Silvia Garcia-Diaz
- Rheumatology Department, Complex Hospitalari Moises Broggi, Barcelona, Spain
| | | | - Kim Lauper
- Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Science, The University of Manchester, Manchester, UK
- Division of Rheumatology, University of Geneva, Geneva, Switzerland
| | - Mariana Luís
- Rheumatology, Centro Hospitalar e Universitário de Coimbra EPE, Coimbra, Portugal
| | - Jacques Morel
- Department of Rheumatology, Montpellier University Hospital, University of Montpellier, Montpellier, France
| | - György Nagy
- Department of Rheumatology and Clinical Immunology, Department of Internal Medicine and Oncology, Semmelweis University, Budapest, Hungary
- Heart and Vascular Center, Semmelweis University, Budapest, Hungary
- Department of Genetics, Cell- and Immunobiology, Semmelweis University, Budapest, Hungary
| | - Eva Polverino
- Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Ciber de Enfermedades Respiratorias CIBERES, Barcelona, Spain
| | - Jef van Rompay
- Belgium Patient Partner Program, EULAR People with Arthritis/Rheumatism across Europe (PARE), Antwerpen, Belgium
| | - Marco Sebastiani
- Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy
| | - Anja Strangfeld
- Epidemiology and Health Services Research, German Rheumatism Research Centre (DRFZ) Berlin and Charite University Medicine, Berlin, Germany
| | - Annette de Thurah
- Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
- Department of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark
| | - James Galloway
- Centre for Rheumatic Diseases, King's College London, London, UK
- Rheumatology Department, King's College London, London, UK
| | - Kimme L Hyrich
- Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Science, The University of Manchester, Manchester, UK
- National Institute of Health Research Manchester Biomedical Research Centre, Manchester Academic Health Science Centre, Manchester NHS Foundation Trust, Manchester, UK
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Fragoulis GE, Dey M, Zhao S, Schoones J, Courvoisier D, Galloway J, Hyrich KL, Nikiphorou E. Systematic literature review informing the 2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases. RMD Open 2022; 8:rmdopen-2022-002726. [PMID: 36323488 PMCID: PMC9639159 DOI: 10.1136/rmdopen-2022-002726] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2022] [Accepted: 10/12/2022] [Indexed: 11/05/2022] Open
Abstract
OBJECTIVE To conduct a systematic literature review (SLR) on the screening and prophylaxis of opportunistic and chronic infections in autoimmune inflammatory rheumatic diseases (AIIRD). METHODS SLR (inception-12/2021) based on the following search domains: (1) infectious agents, (2) AIIRD, (3) immunosuppressives/immunomodulators used in rheumatology, (4) screening terms and (5) prophylaxis terms. Articles were retrieved having the terms from (1) AND (2) AND (3) plus terms from (4) OR(5). Databases searched: PubMed, Embase and Cochrane Library. EXCLUSION CRITERIA studies on postoperative infections, paediatric AIIRD, COVID-19, vaccinations and non-Εnglish literature. Study quality was assessed with Newcastle-Ottawa scale for non-randomised controlled trials (RCTs), RoB-Cochrane for RCTs, AMSTAR2 for SLRs. RESULTS From 5641 studies were retrieved, 568 full-text articles were assessed for eligibility, with 194 articles finally included. For tuberculosis, tuberculin skin test (TST) is affected by treatment with glucocorticoids and conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) and its performance is inferior to interferon gamma release assay (IGRA). Agreement between TST and IGRA is moderate to low. For hepatitis B virus (HBV): risk of reactivation is increased in patients positive for hepatitis B surface antigen. Anti-HBcore positive patients are at low risk for reactivation but should be monitored periodically with liver function tests and/or HBV-viral load. Risk for Hepatitis C reactivation is existing but low in patients treated with biological DMARDs. For Pneumocystis jirovecii, prophylaxis treatment should be considered in patients treated with prednisolone ≥15-30 mg/day for >2-4 weeks. CONCLUSIONS Different screening and prophylaxis approaches are described in the literature, partly determined by individual patient and disease characteristics.
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Affiliation(s)
- George E Fragoulis
- Joint Academic Rheumatology Program, National and Kapodistrian University of Athens, First Department of Propaedeutic and Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece
- Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
| | - Mrinalini Dey
- Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK
- Department of Rheumatology, Countess of Chester Hospital NHS Foundation Trust, Chester, UK
| | - Sizheng Zhao
- Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, The University of Manchester, Manchester, UK
| | - Jan Schoones
- Directorate of Research Policy, Leiden University Medical Center, Leiden, The Netherlands
| | | | - James Galloway
- Centre for Rheumatic Diseases, King's College London, London, UK
- Rheumatology Department, King's College London, London, UK
| | - Kimme L Hyrich
- Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, The University of Manchester, Manchester, UK
- National Institute of Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK
| | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King's College London, London, UK
- Rheumatology Department, King's College London, London, UK
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El Jamaly H, Eslick GD, Weltman M. Meta-analysis: hepatitis B reactivation in patients receiving biological therapy. Aliment Pharmacol Ther 2022; 56:1104-1118. [PMID: 35975904 DOI: 10.1111/apt.17155] [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: 03/21/2022] [Revised: 04/12/2022] [Accepted: 07/11/2022] [Indexed: 01/30/2023]
Abstract
BACKGROUND The use of biologics poses a moderate to high risk for hepatitis B virus reactivation (HBVr) in chronic carriers. AIM To determine the prevalence of HBVr with TNF alpha inhibitors, ustekinumab and vedolizumab METHOD: We followed the MOOSE guidelines and conducted a comprehensive literature search. We conducted a systematic search of EMBASE (Ovid), MEDLINE (Ovid) and PubMed. The studies included patients who were chronic and occult HBV carriers with various rheumatological, dermatological or gastroenterological conditions. We used a random effects model using pooled estimates (prevalence of HBVr with 95% confidence intervals (CI)). RESULTS We included 29 studies with 1409 patients infected with HBV. The prevalence of HBVr in chronic carriers of HBV was 17.1% (95% CI: 7.0-35.9, n = 5), 16.6% (95% CI: 9.5-27.5%, n = 6), 40.5% (95% CI: 20.3-64.5%, n = 4) and 19.1% (95% CI: 7.3-41.2%, n = 2), respectively, for adalimumab, etanercept, infliximab and ustekinumab. The respective prevalence for reactivation in patients with occult HBV infection was 5.0% (95% CI: 2.8-8.7%, number of studies: n = 18), 2.6% (95% CI: 1.4-4.7%, n = 18), 4.4% (95% CI: 2.2-8.7%, n = 12) and 6.4% (95% CI: 2.2-16.8, n = 5). There were 39 HBVr (26 in chronic HBV and 13 in the occult group) without any hepatic failure or death. In the chronic HBVr group, only three of 24 patients received antiviral prophylaxis. CONCLUSIONS HBVr prevalence rates differ between the chronic carrier state and the occult carrier state. The uptake of prophylactic antiviral therapy in high-risk groups was low, contrary to clinical practice guidelines.
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Affiliation(s)
- Hydar El Jamaly
- Department of Gastroenterology and Hepatology, Nepean Hospital, Penrith, New South Wales, Australia.,Nepean Clinical School, The University of Sydney, Penrith, New South Wales, Australia
| | - Guy D Eslick
- The NHMRC Centre for Research Excellence for Digestive Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia
| | - Martin Weltman
- Department of Gastroenterology and Hepatology, Nepean Hospital, Penrith, New South Wales, Australia.,Nepean Clinical School, The University of Sydney, Penrith, New South Wales, Australia
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10
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Hernandez N, Bessone F. Hepatotoxicity Induced by Biological Agents: Clinical Features and Current Controversies. J Clin Transl Hepatol 2022; 10:486-495. [PMID: 35836762 PMCID: PMC9240255 DOI: 10.14218/jcth.2021.00243] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2021] [Revised: 10/24/2021] [Accepted: 12/15/2021] [Indexed: 12/13/2022] Open
Abstract
Novel biological agents including cytokines and recombinant fusion proteins are increasingly prescribed for cancer, rheumatologic, autoimmune, and inflammatory diseases, and are currently being evaluated in hepatocellular carcinoma (HCC). They are classified by their mechanism of action and include tumor necrosis factor-alpha (TNF-α) antagonists, T cell mediated antitumor inhibitors, interleukin receptor antagonists, and immune checkpoint inhibitors (ICIs). Some ICIs cause frequent hepatotoxicity with a variable clinical, biochemical, and serological presentation, especially in patients receiving another immunomodulatory agent. Half of the cases of liver damage induced by biological agents spontaneously regress after drug withdrawal, but the others require steroid therapy. Unfortunately, there are no widely accepted recommendation for the use of corticosteroids in these patients, even though international cancer societies have their own guidelines. Differentiating drug-induced autoimmune hepatitis (DIAIH) from classic AIH is challenging for pathologists, but liver biopsy is valuable, particularly in cases with unclear clinical presentation. Interesting, novel histological patterns have been described in liver damage induced by these agents (i.e., endothelitis, ring granuloma and secundary sclerosing cholangitis associated with lymphocytic infiltration of cytotoxic CD8+T cells). Here, we describe the clinical and biochemical characteristics of patients with hepatotoxicity induced by TNF-α antagonists and ICIs. Controversial issues involved in the administration of corticosteroid therapy, and hepatitis B virus (HBV) reactivation induced by immunosuppressive therapy are also discussed.
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Affiliation(s)
- Nelia Hernandez
- Hospital de Clinicas, Universidad de la Republica, Montevideo, Uruguay
| | - Fernando Bessone
- Hospital Provincial del Centenario, University of Rosario School of Medicine, Rosario, Argentina
- Correspondence to: Fernando Bessone, Facultad de Ciencias Médicas, Hospital Provincial del Centenario, University of Rosario School of Medicine, Rosario, Argentina. ORCID: https://orcid.org/0000-0002-8569-8123. Tel: +54-341-5026969, Fax: +54-341-4387014, E-mail:
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11
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Li L, Jiang X, Fu L, Zhang L, Feng Y. Reactivation rates of hepatitis B or C or HIV in patients with psoriasis using biological therapies: a systematic review and meta-analysis. Clin Exp Med 2022:10.1007/s10238-022-00827-y. [PMID: 35499793 DOI: 10.1007/s10238-022-00827-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] [Received: 01/17/2022] [Accepted: 03/22/2022] [Indexed: 02/05/2023]
Abstract
Some biological therapies for psoriasis can cause the reactivation of viral infections. Although recent studies suggest no increased rate of reactivation with biological therapies, some life-threatening cases have been reported. Therefore, this meta-analysis examined the rate of virus reactivation in patients with psoriasis with biological therapies and concurrent hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. PubMed, Embase, and the Cochrane Library were searched for available papers from inception to December 2021. The outcome was the number of patients with virus reactivation after using biological therapies. The random-effect model was used in all analyses. Fourteen reports (1033 patients) were included. The pooled overall rate of virus reactivation was 0.04 (95%CI 0.01-0.09; I2 = 67.7%, P < 0.001). The pooled rates of HBV, HCV, and HIV reactivation were 0.04 (95%CI 0.00-0.10; I2 = 79.9%, P < 0.001), 0.07 (95%CI 0.02-0.14; I2 = 23.7%, P = 0.24), and 0.12 (95%CI 0.00-0.40), respectively. The pooled rates of HBV and HCV reactivation were 0.10 (95%CI 0.03-0.19) and 0.08 (95%CI 0.03-0.15) in Asia, but 0.00 (95%CI 0.00-0.01) and 0.04 (95%CI 0.00-0.21) in Europe. The publication type also influenced the results. The use of biological therapy in patients with psoriasis and HBV, HCV, or HIV infection might be associated with the rate of viral reactivation, but this meta-analysis had limitations, and the evidence might be weak. Nevertheless, it might suggest that at least a consultation with an infection specialist might be warranted in patients with psoriasis in whom biological therapies are considered.
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Affiliation(s)
- Lin Li
- Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
- Department of Dermatology, Chengdu Second People's Hospital, Chengdu, Sichuan, China
| | - Xian Jiang
- Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
- Laboratory of Dermatology, Clinical Institute of Inflammation and Immunology, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu, 610041, China.
| | - Lixin Fu
- Department of Dermatology, Chengdu Second People's Hospital, Chengdu, Sichuan, China
| | - Liwen Zhang
- Department of Dermatology, Chengdu Second People's Hospital, Chengdu, Sichuan, China
| | - Yanyan Feng
- Department of Dermatology, Chengdu Second People's Hospital, Chengdu, Sichuan, China
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12
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Anti-rheumatic drug-induced hepatitis B virus reactivation and preventive strategies for hepatocellular carcinoma. Pharmacol Res 2022; 178:106181. [PMID: 35301112 DOI: 10.1016/j.phrs.2022.106181] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/21/2022] [Revised: 03/10/2022] [Accepted: 03/11/2022] [Indexed: 12/13/2022]
Abstract
To date, an estimated 3 million people worldwide have been infected with chronic hepatitis B virus (HBV). Although anti-HBV therapies have improved the long-term survival profile of chronic carriers, viral reactivation still poses a significant challenge for preventing HBV-related hepatitis, hepatocellular carcinoma (HCC), and death. Immuno-modulating drugs, which are widely applied in managing rheumatic conditions, are commonly associated with HBV reactivation (HBVr) as a result of drug-induced immune suppression. However, there are few reports on the risk of HBVr and the medication management plan for HBV carriers, especially rheumatic patients. In this review, we summarize immuno-modulating drug-induced HBVr during rheumatoid therapy and its preventive strategies for HBVr-induced liver diseases, especially cirrhosis and HCC. These findings will assist with developing treatments for rheumatic patients, and prevent HBV-related cirrhosis and HCC.
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13
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Chang Y, Jeong SW, Jang JY. Hepatitis B Virus Reactivation Associated With Therapeutic Interventions. Front Med (Lausanne) 2022; 8:770124. [PMID: 35096867 PMCID: PMC8795508 DOI: 10.3389/fmed.2021.770124] [Citation(s) in RCA: 20] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Accepted: 12/20/2021] [Indexed: 12/14/2022] Open
Abstract
Hepatitis B virus (HBV) reactivation associated with various therapeutic interventions is an important cause of morbidity and mortality in patients with current or resolved HBV infection. Because no curative treatment for HBV infection is yet available, there are many individuals at risk for HBV reactivation in the general population. Populations at risk for HBV reactivation include patients who are currently infected with HBV or who have been exposed to HBV in the past. HBV reactivation and its potential consequences is a concern when these populations are exposed to anti-cancer chemotherapy, immunosuppressive or immunomodulatory therapies for the management of various malignancies, rheumatologic diseases, inflammatory bowel disease, or solid-organ or hematologic stem cell transplantation. Accordingly, it has become important to understand the basics of HBV reactivation and the mechanisms by which certain therapies are more susceptible to HBV reactivation. This review aims to raise the awareness of HBV reactivation and to understand the mechanisms and the risks of HBV reactivation in various clinical settings.
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Affiliation(s)
- Young Chang
- Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, South Korea
| | - Soung Won Jeong
- Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, South Korea
| | - Jae Young Jang
- Department of Internal Medicine, Institute for Digestive Research, Digestive Disease Center, Soonchunhyang University College of Medicine, Seoul, South Korea
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14
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Patel S, Kumthekar A. Psoriatic Arthritis: The Influence of Co-morbidities on Drug Choice. Rheumatol Ther 2022; 9:49-71. [PMID: 34797530 PMCID: PMC8814223 DOI: 10.1007/s40744-021-00397-7] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2021] [Accepted: 09/28/2021] [Indexed: 12/20/2022] Open
Abstract
Psoriatic arthritis (PsA) is associated with a higher burden of co-morbidities such as obesity, cardiovascular disease, non-alcoholic fatty liver disease, inflammatory eye disease, inflammatory bowel disease, skin cancer and depression compared to the general population. In the last 20 years, the therapeutic options for PsA have increased exponentially with the availability of tumor necrosis factor-alpha (TNF) inhibitors, interleukin (IL)-17 inhibitors, IL-12/23 inhibitors and Janus kinases/signal transducer and activator of transcription proteins (JAK/STAT) inhibitors. The articular and extra-articular manifestations of PsA usually dictate the treatment choice but important consideration must be given to the corresponding co-morbidities while deciding the drug therapy due to associated safety profile, effect on disease activity, etc. This review provides a comprehensive review of common co-morbidities in PsA and how they can influence treatment choices.
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Affiliation(s)
- Sneha Patel
- Rheumatology, Acclaim Physicians/JPS Hospital, Fort Worth, TX, USA
| | - Anand Kumthekar
- Division of Rheumatology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY, USA.
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15
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Wu YL, Ke J, Zhang BY, Zhao D. Hepatitis B virus reactivation in rheumatoid arthritis. World J Clin Cases 2022; 10:12-22. [PMID: 35071501 PMCID: PMC8727249 DOI: 10.12998/wjcc.v10.i1.12] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/07/2021] [Revised: 09/16/2021] [Accepted: 11/28/2021] [Indexed: 02/06/2023] Open
Abstract
Rheumatoid arthritis (RA) is an autoimmune disease characterized by proliferative synovitis, which can cause cartilage and bone damage as well as functional limitations. Disease-modifying anti-rheumatic drugs have significantly improved the prognosis of RA patients. However, people with RA, when combined with hepatitis B virus (HBV) infection, may experience reactivation of HBV during treatment with anti-rheumatic drugs. The outcome of HBV reactivation (HBVr) varies from liver inflammation to liver failure, while insufficient HBV screening in RA patients has been reported in various countries. Therefore, it is necessary to identify patients at high risk before starting immunosuppressive therapy. The immune response plays an important role in anti-HBV infection. However, most anti-rheumatic drugs exert an inhibitory effect on the body's immune system, resulting in HBVr. Therefore, it is necessary to conduct a comprehensive evaluation based on host factors, viral factors, and drug factors. In this paper, we summarize the mechanism of HBVr, the risk of HBVr caused by anti-rheumatic drugs, and the appropriate diagnosis and treatment process for RA patients so that clinicians can have a more comprehensive understanding of HBVr in RA patients.
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Affiliation(s)
- Ya-Li Wu
- Center for Endocrine Metabolism and Immune Diseases, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China
| | - Jing Ke
- Center for Endocrine Metabolism and Immune Diseases, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China
| | - Bao-Yu Zhang
- Center for Endocrine Metabolism and Immune Diseases, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China
| | - Dong Zhao
- Center for Endocrine Metabolism and Immune Diseases, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China
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16
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Nagy G, Roodenrijs NMT, Welsing PMJ, Kedves M, Hamar A, van der Goes MC, Kent A, Bakkers M, Pchelnikova P, Blaas E, Senolt L, Szekanecz Z, Choy EH, Dougados M, Jacobs JW, Geenen R, Bijlsma JW, Zink A, Aletaha D, Schoneveld L, van Riel P, Dumas S, Prior Y, Nikiphorou E, Ferraccioli G, Schett G, Hyrich KL, Mueller-Ladner U, Buch MH, McInnes IB, van der Heijde D, van Laar JM. EULAR points to consider for the management of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis 2022; 81:20-33. [PMID: 34407926 PMCID: PMC8761998 DOI: 10.1136/annrheumdis-2021-220973] [Citation(s) in RCA: 103] [Impact Index Per Article: 34.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2021] [Accepted: 07/23/2021] [Indexed: 12/17/2022]
Abstract
OBJECTIVE To develop evidence-based European Alliance of Associations for Rheumatology (EULAR) points to consider (PtCs) for the management of difficult-to-treat rheumatoid arthritis (D2T RA). METHODS An EULAR Task Force was established comprising 34 individuals: 26 rheumatologists, patient partners and rheumatology experienced health professionals. Two systematic literature reviews addressed clinical questions around diagnostic challenges, and pharmacological and non-pharmacological therapeutic strategies in D2T RA. PtCs were formulated based on the identified evidence and expert opinion. Strength of recommendations (SoR, scale A-D: A typically consistent level 1 studies and D level 5 evidence or inconsistent studies) and level of agreement (LoA, scale 0-10: 0 completely disagree and 10 completely agree) of the PtCs were determined by the Task Force members. RESULTS Two overarching principles and 11 PtCs were defined concerning diagnostic confirmation of RA, evaluation of inflammatory disease activity, pharmacological and non-pharmacological interventions, treatment adherence, functional disability, pain, fatigue, goal setting and self-efficacy and the impact of comorbidities. The SoR varied from level C to level D. The mean LoA with the overarching principles and PtCs was generally high (8.4-9.6). CONCLUSIONS These PtCs for D2T RA can serve as a clinical roadmap to support healthcare professionals and patients to deliver holistic management and more personalised pharmacological and non-pharmacological therapeutic strategies. High-quality evidence was scarce. A research agenda was created to guide future research.
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Affiliation(s)
- György Nagy
- Department of Rheumatology & Clinical Immunology, Semmelweis University, Budapest, Hungary
- Department of Genetics, Cell and Immunobiology, Semmelweis University, Budapest, Hungary
| | - Nadia M T Roodenrijs
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Paco M J Welsing
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Melinda Kedves
- Bács-Kiskun County Hospital, Rheumatology Department, Kecskemét, Hungary
| | - Attila Hamar
- Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary
| | - Marlies C van der Goes
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
- Department of Rheumatology, Meander Medical Center, Amersfoort, The Netherlands
| | - Alison Kent
- Salisbury Foundation Trust NHS Hospital, Wiltshire, UK
| | - Margot Bakkers
- EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), Zurich, Switzerland
| | - Polina Pchelnikova
- EULAR Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), Zurich, Switzerland
| | - Etienne Blaas
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Ladislav Senolt
- Department of Rheumatology, 1st Faculty of Medicine, Charles University and Institute of Rheumatology, Prague, Czech Republic
| | - Zoltan Szekanecz
- Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary
| | - Ernest H Choy
- CREATE Centre, Section of Rheumatology, School of Medicine, Division of Infection and Immunity, Cardiff University, Cardiff, UK
| | - Maxime Dougados
- Université de Paris Department of Rheumatology - Hôpital Cochin. Assistance Publique - Hôpitaux de Paris INSERM (U1153) Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité, Paris, France
| | - Johannes Wg Jacobs
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Rinie Geenen
- Department of Psychology, Utrecht University, Utrecht, The Netherlands
| | - Johannes Wj Bijlsma
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Angela Zink
- Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany
| | - Daniel Aletaha
- Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
| | - Leonard Schoneveld
- Department of Rheumatology, Bravis Hospital, Roosendaal, The Netherlands
| | - Piet van Riel
- Department of Rheumatic Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
| | - Sophie Dumas
- Department of Pharmacy, Marin Hospital, Asisstance Publique-Hopitaux de Paris, Hendaye, France
| | - Yeliz Prior
- School of Health and Society, Centre for Health Sciences Research, University of Salford, Salford, UK
| | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King's College London, London, UK
- Rheumatology Department, King's College Hospital, London, UK
| | | | - Georg Schett
- Department of Internal Medicine 3, Rheumatology and Immunology, Friedrich-Alexander University of Erlangen-Nuremberg and Universitatsklinikum Erlangen, Erlangen, Germany
| | - Kimme L Hyrich
- NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
- Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK
| | - Ulf Mueller-Ladner
- Department of Rheumatology and Clinical Immunology, Justus-Liebig University Giessen, Campus Kerckhoff, Bad Nauheim, Germany
| | - Maya H Buch
- NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
- Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK
- Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds, Leeds, UK
| | - Iain B McInnes
- Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
| | | | - Jacob M van Laar
- Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
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17
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Kłujszo EH, Zarębska-Michaluk D, Kręcisz B, Witkowska A. Safety of therapies using ustekinumab in patients with psoriasis who have had hepatitis B virus infection. Dermatol Ther 2021; 35:e15274. [PMID: 34921578 DOI: 10.1111/dth.15274] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2021] [Accepted: 12/10/2021] [Indexed: 12/22/2022]
Abstract
Biological therapies used in psoriasis treatment pose a risk of reactivation of hepatitis B virus (HBV) infection. This risk occurs not only in patients with HB surface antigen (HBsAg) (+) but also in patients with past or occult HBV infection (with negative HBsAg, positive HB core antibodies (HBcAb), and positive HBV deoxyribonucleic acid [DNA]). Ustekinumab (UST) is a biologic agent acts by blocking the IL-12/23 pathway. Thus, hindering this response may lead to HBV reactivation. UST therapy is associated with mild HBV-r risk; however, there is insufficient data to confirm that hypothesis. Herein, we present observations on the safety of UST therapy in patients with psoriasis and serologically proved past HBV infection. One-hundred and six consecutive patients with moderate to severe psoriasis treated with biological therapy between May 2013 and January 2020 were retrospectively analyzed. Out of 106 patients, there were five who reported having past HBV. Those five patients were tested for the presence of HBsAg, HBcAb, HBsAb as well as HBV DNA at baseline and at the end of the follow-up period. HBV reactivation was defined as changing of "undetectable" to "detectable" viremia. All five patients were treated with UST. Five patients in our cohort group were found to have resolved HBV infection: HBsAg (-), HBcAb (+), and HBV DNA (-); 4/5 were HBsAb (+) and 1/5 HBsAb (-). None of the patients experienced an increase in their liver function tests values and no signs of hepatitis or HBV reactivation were observed at any point during the study. All the patients were HBsAg and HBV DNA negative at the end of the follow-up period. The average treatment time was 82.4 (28, 96) weeks. The average follow-up time was 75.2 (31, 176) weeks. Based on the available literature and the results from our observations, UST therapy seems to be a safe option for patients with resolved HBV infection.
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Affiliation(s)
| | | | - Beata Kręcisz
- Faculty of Medicine and Health Science, Jan Kochanowski University in Kielce, Kielce, Poland
| | - Anna Witkowska
- Department of Rheumatology, Mater Misericordiae University Hospital, Dublin, Ireland
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18
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Onorato L, Pisaturo M, Camaioni C, Grimaldi P, Codella AV, Calò F, Coppola N. Risk and Prevention of Hepatitis B Virus Reactivation during Immunosuppression for Non-Oncological Diseases. J Clin Med 2021; 10:5201. [PMID: 34768721 PMCID: PMC8584565 DOI: 10.3390/jcm10215201] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2021] [Revised: 10/30/2021] [Accepted: 11/03/2021] [Indexed: 12/31/2022] Open
Abstract
Reactivation of overt or occult HBV infection (HBVr) is a well-known, potentially life-threatening event which can occur during the course of immunosuppressive treatments. Although it has been described mainly in subjects receiving therapy for oncological or hematological diseases, the increasing use of immunosuppressant agents in non-oncological patients observed in recent years has raised concerns about the risk of reactivation in several other settings. However, few data can be found in the literature on the occurrence of HBVr in these populations, and few clear recommendations on its management have been defined. The present paper was written to provide an overview of the risk of HBV reactivation in non-neoplastic patients treated with immunosuppressive drugs, particularly for rheumatological, gastrointestinal, dermatological and neurological diseases, and for COVID-19 patients receiving immunomodulating agents; and to discuss the potential strategies for prevention and treatment of HBVr in these settings.
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Affiliation(s)
- Lorenzo Onorato
- Department of Mental Health and Public Medicine, Faculty of Medicine, University of Campania Luigi Vanvitelli, Via L. Armanni 5, 80138 Naples, Italy; (L.O.); (M.P.); (C.C.); (P.G.)
- Infectious Diseases Unit, Azienda Ospedaliera Universitaria Luigi Vanvitelli, Via Pansini 5, 80138 Naples, Italy; (A.V.C.); (F.C.)
| | - Mariantonietta Pisaturo
- Department of Mental Health and Public Medicine, Faculty of Medicine, University of Campania Luigi Vanvitelli, Via L. Armanni 5, 80138 Naples, Italy; (L.O.); (M.P.); (C.C.); (P.G.)
| | - Clarissa Camaioni
- Department of Mental Health and Public Medicine, Faculty of Medicine, University of Campania Luigi Vanvitelli, Via L. Armanni 5, 80138 Naples, Italy; (L.O.); (M.P.); (C.C.); (P.G.)
| | - Pierantonio Grimaldi
- Department of Mental Health and Public Medicine, Faculty of Medicine, University of Campania Luigi Vanvitelli, Via L. Armanni 5, 80138 Naples, Italy; (L.O.); (M.P.); (C.C.); (P.G.)
| | - Alessio Vinicio Codella
- Infectious Diseases Unit, Azienda Ospedaliera Universitaria Luigi Vanvitelli, Via Pansini 5, 80138 Naples, Italy; (A.V.C.); (F.C.)
| | - Federica Calò
- Infectious Diseases Unit, Azienda Ospedaliera Universitaria Luigi Vanvitelli, Via Pansini 5, 80138 Naples, Italy; (A.V.C.); (F.C.)
| | - Nicola Coppola
- Department of Mental Health and Public Medicine, Faculty of Medicine, University of Campania Luigi Vanvitelli, Via L. Armanni 5, 80138 Naples, Italy; (L.O.); (M.P.); (C.C.); (P.G.)
- Infectious Diseases Unit, Azienda Ospedaliera Universitaria Luigi Vanvitelli, Via Pansini 5, 80138 Naples, Italy; (A.V.C.); (F.C.)
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19
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Akiyama S, Cotter TG, Sakuraba A. Risk of hepatitis B virus reactivation in patients with autoimmune diseases undergoing non-tumor necrosis factor-targeted biologics. World J Gastroenterol 2021; 27:2312-2324. [PMID: 34040324 PMCID: PMC8130042 DOI: 10.3748/wjg.v27.i19.2312] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2021] [Revised: 02/27/2021] [Accepted: 04/22/2021] [Indexed: 02/06/2023] Open
Abstract
Hepatitis B virus reactivation (HBVr) can occur in patients treated with immunosuppressive medications. Risk stratification for HBVr based on hepatitis B virus (HBV) serology and viral load is an important strategy to determine appropriate HBV monitoring and antiviral prophylaxis use. Recent advances in the understanding of pathophysiology of autoimmune diseases have led the development of cytokine-targeted therapies. Tumor necrosis factor (TNF)-α inhibitors have been widely used for patients with inflammatory bowel disease, psoriasis, and rheumatic diseases. Further, the clinical benefits of interleukin (IL)-12/23, IL-17, or Janus kinases inhibitors have been demonstrated in these patients. It is well known that TNF-α inhibitor use can lead to HBVr, however, the risk of HBVr in patients undergoing non-TNF-targeted biologics have not been fully understood. In this review, we discuss the risk of HBVr in patients treated with non-TNF-targeted biologics, and immunological mechanisms of these medications causing HBVr.
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Affiliation(s)
- Shintaro Akiyama
- Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL 60637, United States
| | - Thomas G Cotter
- Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL 60637, United States
| | - Atsushi Sakuraba
- Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL 60637, United States
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20
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Roodenrijs NMT, Hamar A, Kedves M, Nagy G, van Laar JM, van der Heijde D, Welsing PMJ. Pharmacological and non-pharmacological therapeutic strategies in difficult-to-treat rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of difficult-to-treat rheumatoid arthritis. RMD Open 2021; 7:e001512. [PMID: 33419871 PMCID: PMC7798678 DOI: 10.1136/rmdopen-2020-001512] [Citation(s) in RCA: 28] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Revised: 12/16/2020] [Accepted: 12/21/2020] [Indexed: 12/14/2022] Open
Abstract
OBJECTIVES To summarise, by a systematic literature review (SLR), the evidence regarding pharmacological and non-pharmacological therapeutic strategies in difficult-to-treat rheumatoid arthritis (D2T RA), informing the EULAR recommendations for the management of D2T RA. METHODS PubMed, Embase and Cochrane databases were searched up to December 2019. Relevant papers were selected and appraised. RESULTS Two hundred seven (207) papers studied therapeutic strategies. Limited evidence was found on effective and safe disease-modifying antirheumatic drugs (DMARDs) in patients with comorbidities and other contraindications that limit DMARD options (patients with obesity, hepatitis B and C, risk of venous thromboembolisms, pregnancy and lactation). In patients who previously failed biological (b-)DMARDs, all currently used b/targeted synthetic (ts-)DMARDs were found to be more effective than placebo. In patients who previously failed a tumour necrosis factor inhibitor (TNFi), there was a tendency of non-TNFi bDMARDs to be more effective than TNFis. Generally, effectiveness decreased in patients who previously failed a higher number of bDMARDs. Additionally, exercise, psychological, educational and self-management interventions were found to improve non-inflammatory complaints (mainly functional disability, pain, fatigue), education to improve goal setting, and self-management programmes, educational and psychological interventions to improve self-management.The identified evidence had several limitations: (1) no studies were found in patients with D2T RA specifically, (2) heterogeneous outcome criteria were used and (3) most studies had a moderate or high risk of bias. CONCLUSIONS This SLR underscores the scarcity of high-quality evidence on the pharmacological and non-pharmacological treatment of patients with D2T RA. Effectiveness of b/tsDMARDs decreased in RA patients who had failed a higher number of bDMARDs and a subsequent b/tsDMARD of a previously not targeted mechanism of action was somewhat more effective. Additionally, a beneficial effect of non-pharmacological interventions was found for improvement of non-inflammatory complaints, goal setting and self-management.
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Affiliation(s)
- Nadia M T Roodenrijs
- Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
| | - Attila Hamar
- Rheumatology, University of Debrecen, Debrecen, Hungary
| | - Melinda Kedves
- Rheumatology, Bacs-Kiskun Megyei Korhaz, Kecskemet, Hungary
| | - György Nagy
- Genetics, Cell- and Immunobiology & Rheumatology & Clinical Rheumatology, Semmelweis University, Budapest, Hungary
| | - Jacob M van Laar
- Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
| | | | - Paco M J Welsing
- Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
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21
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Ekpanyapong S, Reddy KR. Hepatitis B Virus Reactivation: What Is the Issue, and How Should It Be Managed? Clin Liver Dis 2020; 24:317-333. [PMID: 32620274 DOI: 10.1016/j.cld.2020.04.002] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Hepatitis B virus (HBV) reactivation, in the background of cleared and overt chronic HBV infection, can be seen in patients receiving immunosuppressive agents. Risk of reactivation is variably associated with HBV serologic status and types of immunosuppressive therapy. Prevention of HBV reactivation by antiviral prophylaxis is an effective strategy to reduce morbidity and mortality in those with immunocompromised states. This article defines HBV reactivation, discusses risk stratification and common medications that can induce HBV reactivation as well as guideline recommendations for prevention of HBV reactivation, and describes the prognosis and management of patients who experience HBV reactivation.
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Affiliation(s)
- Sirina Ekpanyapong
- Department of Medicine, Division of Gastroenterology and Hepatology, Vejthani Hospital, 1 Soi Lat Phrao 111, Khlong Chan, Bang Kapi District, Bangkok 10240, Thailand
| | - K Rajender Reddy
- Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, 3400 Spruce Street, 2 Dulles HUP, Philadelphia, PA 19104, USA.
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Abstract
INTRODUCTION Hepatitis B virus (HBV) reactivation can be induced by treatments that attenuate the immunological control over HBV, leading to increased morbidity and mortality. The risk of HBV reactivation is determined by host immunity, viral factors, and the type and dose of treatments. Nevertheless, the risk of HBV reactivation for a growing number of novel therapies remains uncertain and needs to be carefully examined. Identification of patients at risk and administration of prophylactic antiviral agents are critical to prevent HBV reactivation. Early diagnosis and initiation of antiviral treatment are the keys to avoid devastating outcomes. AREA COVERED We summarized the latest evidence and recommendations for risk stratification, early diagnosis, prophylaxis, and management of HBV reactivation. EXPERT OPINION Universal screening, adequate prophylaxis, and close monitoring are essential for the prevention of HBV reactivation. Risk stratification of patients at risk with appropriate antiviral prophylaxis can prevent HBV reactivation effectively. Several emerging biomarkers have been proved to help determine the risk precisely. Early detection and timely administration of antiviral agents are crucial for management. Further studies on the precision of risk stratification as well as the optimal duration of prophylaxis and treatment are needed to establish an individualized strategy.
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Affiliation(s)
- Shang-Chin Huang
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital , Taipei, Taiwan
| | - Hung-Chih Yang
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital , Taipei, Taiwan.,Hepatitis Research Center, National Taiwan University Hospital , Taipei, Taiwan.,Department of Microbiology, National Taiwan University College of Medicine Taipei , Taiwan
| | - Jia-Horng Kao
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital , Taipei, Taiwan.,Hepatitis Research Center, National Taiwan University Hospital , Taipei, Taiwan.,Department of Medical Research, National Taiwan University Hospital , Taipei, Taiwan.,Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine , Taipei, Taiwan
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Abstract
Hepatitis B virus (HBV) reactivation can be a serious complication for patients with chronic or resolved HBV infection when treated with biologics. For HBsAg-positive patients receiving biologics, the risk of HBV reactivation is moderate to high. HBsAg-negative/anti-HBc positive patients are at lower risk of HBV reactivation than HBsAg-positive patients. However, patients taking anti-CD20 agents, such as rituximab, have high risk of HBV reactivation (>10%), so antiviral prophylactic therapies are required. This review provides the different classes of biologics associated with HBV reactivation, stratifies the various reactivation risk levels by HBV status and biologic agent, and discusses management strategies.
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Affiliation(s)
- Eiichi Ogawa
- Department of General Internal Medicine, Kyushu University Hospital, 3-1-1 Maidashi Higashi-ku, Fukuoka 8128582, Japan
| | - Mike T Wei
- Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, 750 Welch Road, Suite 210, Palo Alto, CA 94304, USA
| | - Mindie H Nguyen
- Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, 750 Welch Road, Suite 210, Palo Alto, CA 94304, USA.
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24
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Kuo MH, Tseng CW, Lee CH, Tung CH, Tseng KC, Lai NS. Moderate Risk of Hepatitis B Virus Reactivation in HBsAg -/HBcAb + Carriers Receiving Rituximab for Rheumatoid Arthritis. Sci Rep 2020; 10:2456. [PMID: 32051458 PMCID: PMC7016116 DOI: 10.1038/s41598-020-59406-4] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2019] [Accepted: 01/28/2020] [Indexed: 12/26/2022] Open
Abstract
To investigate the incidence and risk factors of hepatitis B virus (HBV) reactivation in HBV surface antigen (HBsAg)-/ HBV core antibody (HBcAb)+ patients who underwent rituximab (RTX) therapy for rheumatoid arthritis (RA). From January 2000 through December 2017, a total of 134 RA patients with various HBV serostatuses who received RTX at Dalin Tzu Chi Hospital were screened. Finally, 50 HBsAg-/HBcAb+ patients were enrolled in this retrospective study. Baseline characteristics, comedications, and the occurrence of HBV reactivation were recorded. Four HBsAg-/HBcAb+ RA patients (8%; 4/50) experienced HBV reactivation after treatment with RTX. Hepatitis flare-up occurred in 2 of these 4 patients, with a fatal outcome in one. HBV reactivation occurred approximately 1-4 years after the first dose of RTX and 0.5-1.5 years after the last one. In HBsAg-/HBcAb+ patients, HBV reactivation was significantly more common in those who were HBV surface antibody (HBsAb)- at baseline than in those who were HBsAb+ (30% vs 4%; p = 0.02). A history of adalimumab use was associated with HBV reactivation (100% vs 39%; p = 0.02). A moderate risk of HBV reactivation was observed in HBsAg-/HBcAb+ RA patients receiving RTX therapy. The reactivation may induce acute hepatitis and even death. To reduce the risk of HBV reactivation, regular monitoring of liver function is insufficient; monitoring of viral load and HBsAg or prophylaxis with antiviral therapy should be considered.
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Affiliation(s)
- Meng Hsuan Kuo
- Department of Pharmacy, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan
- School of Medicine, Tzuchi University, Hualien, Taiwan
| | - Chih-Wei Tseng
- School of Medicine, Tzuchi University, Hualien, Taiwan.
- Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan.
| | - Chi-Hui Lee
- Department of Pharmacy, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan
- School of Medicine, Tzuchi University, Hualien, Taiwan
| | - Chien-Hsueh Tung
- School of Medicine, Tzuchi University, Hualien, Taiwan
- Division of Rheumatology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan
| | - Kuo-Chih Tseng
- School of Medicine, Tzuchi University, Hualien, Taiwan
- Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan
| | - Ning-Sheng Lai
- School of Medicine, Tzuchi University, Hualien, Taiwan
- Division of Rheumatology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chia-Yi, Taiwan
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25
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Chiu YM, Chen DY. Infection risk in patients undergoing treatment for inflammatory arthritis: non-biologics versus biologics. Expert Rev Clin Immunol 2020; 16:207-228. [PMID: 31852268 DOI: 10.1080/1744666x.2019.1705785] [Citation(s) in RCA: 48] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
Introduction: Despite the therapeutic effectiveness of biologics targeting immune cells or cytokines in patients with inflammatory arthritis, which reflects their pathogenic roles, an increased infection risk is observed in those undergoing biological treatment. However, there are limited data regarding the comparison of infection risks in inflammatory arthritis patients treated with non-biologics (csDMARDs), biologics (bDMARDs), including tumor necrosis factor (TNF) inhibitors and non-TNF inhibitors, or targeted synthetic (ts)DMARDs.Areas covered: Through a review of English-language literature as of 30 June 2019, we focus on the existing evidence on the risk of infections caused by bacteria, Mycobacterium tuberculosis, and hepatitis virus in inflammatory arthritis patients undergoing treatment with csDMARDs, bDMARDs, or tsDMARDs.Expert opinion: While the risks of bacterial and mycobacterial infection are increased in arthritis patients treated with csDMARDs, the risks are further higher in those receiving bDMARDs therapy, particularly TNF inhibitors. Regarding HBV infection, antiviral therapy may effectively prevent HBV reactivation in patients receiving bDMARDs, especially rituximab. However, more data are needed to establish effective preventive strategies for HBsAg-negative/HBcAb-positive patients. It seems safe to use cyclosporine and TNF inhibitors in patients with HCV infection, while those undergoing rituximab therapies should be frequently monitored for HCV activity.Abbreviations: ABT: abatacept; ADA: adalimumab; AS: ankylosing spondylitis; bDMARDs: biologic disease-modifying anti-rheumatic drugs; CKD: chronic kidney disease; COPD: chronic obstructive pulmonary disease; CS: corticosteroids; CsA: cyclosporine A; csDMARDs: conventional synthetic disease-modifying anti-rheumatic drugs; CZP: certolizumab; DAAs: direct-acting antiviral agents; DM: diabetes mellitus; DOT: directly observed therapy; EIN: Emerging Infections Network; ETN: etanercept; GOL: golimumab; GPRD: General Practice Research Database; HBV: hepatitis B virus; HBVr: HBV reactivation; HBsAg+: HBsAg-positive; HBsAg-/anti-HBc+: HBsAg-negative anti-HBc antibodies-positive; HCV: hepatitis C virus; HCQ: hydroxychloroquine: IFX: infliximab; IL-6: interleukin-6; JAK: Janus kinase; LEF: leflunomide; LTBI: latent tuberculosis infection; mAb: monoclonal antibody; MTX: methotrexate; OR: odds ratio; PsA: psoriatic arthritis; PMS: post-marketing surveillance; RA: rheumatoid arthritis; TNF: tumor necrosis factor; TNFi: tumor necrosis factor inhibitor; SCK: secukinumab; SSZ: sulfasalazine; TOZ: tocilizumab; RCT: randomized controlled trial; RR: relative risk; RTX: rituximab; 3HP: 3-month once-weekly isoniazid plus rifapentine; TB: tuberculosis; tsDMARDs: targeted synthetic disease-modifying anti-rheumatic drugs; UTK: ustekinumab; WHO: World Health Organization.
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Affiliation(s)
- Ying-Ming Chiu
- Rheumatology and Immunology Center, China Medical University Hospital, Taichung, Taiwan.,College of Medicine, China Medical University, Taichung, Taiwan
| | - Der-Yuan Chen
- Rheumatology and Immunology Center, China Medical University Hospital, Taichung, Taiwan.,College of Medicine, China Medical University, Taichung, Taiwan.,Translational Medicine Laboratory, Rheumatic Diseases Research Center, China Medical University Hospital, Taichung, Taiwan.,Program in Translational Medicine and Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung, Taiwan.,Institute of Biochemistry, Microbiology and Immunology, Chung Shan Medical University, Taichung, Taiwan
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26
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Managing Psoriasis in Patients with HBV or HCV Infection: Practical Considerations. Am J Clin Dermatol 2019; 20:829-845. [PMID: 31222626 DOI: 10.1007/s40257-019-00457-3] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Considered more efficacious and safer than traditional systemic drugs, biologic therapies have dramatically improved the quality of life of patients with psoriasis. Recently, there has been a proliferation of new targeted treatment options, including anti-interleukin-17, anti-interleukin-12/23, as well as small-molecule drugs such as apremilast. There are nevertheless some concerns regarding their use, especially in patients with chronic infections such as hepatitis B virus (HBV) and hepatitis C virus (HCV). It has been estimated that two billion individuals are infected with HBV worldwide and approximately 240 million have chronic HBV infection. Moreover, there are approximately 71 million individuals with chronic HCV infection worldwide, with a high percentage of them unaware of being infected. As patients with HBV and HCV infections are excluded from controlled clinical trials investigating new drugs, data regarding their safety in patients with psoriasis are based almost exclusively on case reports and small retrospective cohort studies and need to be constantly updated. The risk of HBV reactivation can be defined as: high risk (≥ 10%), moderate risk (1-10%), and low risk (< 1%) depending on the type of immunosuppressive therapy stratified by the presence or absence of hepatitis B surface antigen but positivity to anti-hepatitis B core antigen. Hepatitis B surface antigen-positive patients treated with tumor necrosis factor-α inhibitors, ustekinumab, or cyclosporine carry a high or moderate risk of HBV reactivation and should be considered candidates for prophylactic anti-HBV therapy. Once therapy is commenced, it is important to check HBV DNA levels every 3 months. Hepatitis B virus reactivation typically occurs with immune reconstitution and therefore antiviral therapy should continue for 6-12 months after stopping immunosuppression. Hepatitis B surface antigen-positive patients who are prescribed methotrexate, acitretin, or apremilast have a low risk and need to be monitored for viral reactivation by determining alanine aminotransferase and HBV DNA levels every 3 months. No conclusive data are available for interleukin-17 and interleukin-23 inhibitors. Anti-hepatitis B core antigen-positive patients treated with tumor necrosis factor-α inhibitors, ustekinumab, and cyclosporine are linked to a moderate risk of reactivation, and they should preferably undergo HBV DNA or hepatitis B surface antigen and alanine aminotransferase testing rather than be subjected to routine pre-emptive therapy. Anti-hepatitis B core antigen-positive patients receiving methotrexate, acitretin, or apremilast have a low risk of reactivation and do not require anti-HBV therapy, nor should monitoring be considered mandatory. No conclusive data are available for interleukin-17 and interleukin-23 inhibitors.
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27
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Sasadeusz J, Grigg A, Hughes PD, Lee Lim S, Lucas M, McColl G, McLachlan SA, Peters MG, Shackel N, Slavin M, Sundararajan V, Thompson A, Doyle J, Rickard J, De Cruz P, Gish RG, Visvanathan K. Screening and Prophylaxis to Prevent Hepatitis B Reactivation: Other Populations and Newer Agents. Clin Liver Dis 2019; 23:521-534. [PMID: 31266625 DOI: 10.1016/j.cld.2019.04.012] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Because of the relatively high prevalence of both hepatitis B infection and various forms of autoimmune inflammatory diseases treated with aggressive immunotherapy, reactivation of hepatitis B occurs in a substantial number of patients. The risk of reactivation depends on the degree and duration of immunosuppression. A large number of drug treatments have resulted in reactivation of hepatitis B virus infection and, based on the mechanisms and extent of immunosuppression, recommendations for some of the newer classes of immunosuppressive drugs are provided.
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Affiliation(s)
- Joe Sasadeusz
- Peter Doherty Institute for Infection and Immunity, Elizabeth Street, Melbourne, Victoria 3000, Australia; University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia.
| | - Andrew Grigg
- Olivia Newton John Cancer Research Institute, Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084, Australia
| | - Peter D Hughes
- University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia; Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia
| | - Seng Lee Lim
- National University of Singapore, 21 Lower Kent Ridge Road, Singapore 119077, Singapore
| | - Michaela Lucas
- University of Western Australia, 35 Stirling Highway, Crawley, Western Australia 6009, Australia
| | - Geoff McColl
- University of Queensland Oral Health Centre, 288 Herston Road, Queensland 4006, Australia
| | - Sue Anne McLachlan
- St Vincent's Hospital, 41 Victoria Street, Fitzroy, Victoria 3065, Australia
| | - Marion G Peters
- University of California, San Francisco, S357 Parnassus Avenue, San Francisco, CA 94143, USA
| | - Nicholas Shackel
- Ingham Institute, 1 Campbell Street, Liverpool, Sydney, North South Wales 2170, Australia
| | - Monica Slavin
- Royal Melbourne Hospital, 300 Grattan Street, Parkville, Victoria 3050, Australia; Victorian Comprehensive Cancer Centre, 305 Grattan Street, Melbourne, Victoria 3000, Australia
| | - Vijaya Sundararajan
- University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia; St Vincent's Hospital, 41 Victoria Street, Fitzroy, Victoria 3065, Australia; Department of Public Health, La Trobe University, Plenty Road, Bundoora, Victoria 3086, Australia
| | - Alexander Thompson
- University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia; St Vincent's Hospital, 41 Victoria Street, Fitzroy, Victoria 3065, Australia
| | - Joseph Doyle
- The Alfred and Monash University, 85 Commercial Road, Melbourne, Victoria 3004, Australia; Burnet Institute, 85 Commercial Road, Melbourne, Victoria 3004, Australia
| | - James Rickard
- Olivia Newton John Cancer Research Institute, Austin Hospital, 145 Studley Road, Heidelberg, Victoria 3084, Australia
| | - Peter De Cruz
- University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia
| | - Robert G Gish
- Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University, Stanford University Medical Center, 300 Pasteur Drive, Stanford, CA 94305, USA
| | - Kumar Visvanathan
- University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia; St Vincent's Hospital, 41 Victoria Street, Fitzroy, Victoria 3065, Australia
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28
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Zhang Z, Deng W, Wu Q, Sun L. Tuberculosis, hepatitis B and herpes zoster in tofacitinib-treated patients with rheumatoid arthritis. Immunotherapy 2019; 11:321-333. [PMID: 30630365 DOI: 10.2217/imt-2018-0113] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023] Open
Abstract
There is currently interest in the risk of infections during treatment with new targeted synthetic disease-modifying antirheumatic drugs (DMARDs), specifically the Janus kinase inhibitor tofacitinib. Tofacitinib has been studied extensively in patients with rheumatoid arthritis and has been shown to be effective and generally safe. East Asian countries have a high background rate of tuberculosis (TB) and hepatitis B virus (HBV) infection and the risk of recurrence or reactivation of infections such as TB, HBV and herpes zoster during DMARD therapy is of particular interest in the region. This paper reviews available data on the risk of TB, HBV and herpes zoster infections, including recurrence/reactivation of infections, during treatment with tofacitinib, with a focus on east Asia.
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Affiliation(s)
- Zhuoya Zhang
- Department of Rheumatology & Immunology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China, 210008
| | - Wei Deng
- Pfizer Inc., Beijing, China, 100010
| | - Qizhe Wu
- Pfizer Inc., Beijing, China, 100010
| | - Lingyun Sun
- Department of Rheumatology & Immunology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China, 210008
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29
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Lau CS, Chia F, Dans L, Harrison A, Hsieh TY, Jain R, Jung SM, Kishimoto M, Kumar A, Leong KP, Li Z, Lichauco JJ, Louthrenoo W, Luo SF, Mu R, Nash P, Ng CT, Suryana B, Wijaya LK, Yeap SS. 2018 update of the APLAR recommendations for treatment of rheumatoid arthritis. Int J Rheum Dis 2019; 22:357-375. [PMID: 30809944 DOI: 10.1111/1756-185x.13513] [Citation(s) in RCA: 116] [Impact Index Per Article: 19.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2019] [Accepted: 01/21/2019] [Indexed: 12/11/2022]
Abstract
AIM To update recommendations based on current best evidence concerning the treatment of rheumatoid arthritis (RA), focusing particularly on the role of targeted therapies, to inform clinicians on new developments that will impact their current practice. MATERIALS AND METHODS A search of relevant literature from 2014 to 2016 concerning targeted therapies in RA was conducted. The RA Update Working Group evaluated the evidence and proposed updated recommendations using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach, to describe the quality of evidence and strength of recommendations. Recommendations were finalized through consensus using the Delphi technique. RESULTS This update provides 16 RA treatment recommendations based on current best evidence and expert clinical opinion. Recommendations 1-3 deal with the use of conventional synthetic disease-modifying antirheumatic drugs. The next three recommendations (4-6) cover the need for screening and management of infections and comorbid conditions prior to starting targeted therapy, while the following seven recommendations focus on use of these agents. We address choice of targeted therapy, switch, tapering and discontinuation. The last three recommendations elaborate on targeted therapy for RA in special situations such as pregnancy, cancer, and major surgery. CONCLUSION Rheumatoid arthritis remains a significant health problem in the Asia-Pacific region. Patients with RA can benefit from the availability of effective targeted therapies, and these updated recommendations provide clinicians with guidance on their use.
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Affiliation(s)
- Chak Sing Lau
- Division of Rheumatology and Clinical Immunology, Department of Medicine, The University of Hong Kong, Pokfulam, Hong Kong
| | - Faith Chia
- Department of Rheumatology, Allergy and Immunology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Leonila Dans
- Department of Pediatrics, University of the Philippines Manila, Manila, Philippines.,Department of Clinical Epidemiology, University of the Philippines Manila, Manila, Philippines
| | - Andrew Harrison
- Department of Medicine, University of Otago Wellington, Wellington, New Zealand
| | - Tsu Yi Hsieh
- Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung, Taiwan
| | | | - Seung Min Jung
- Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Mitsumasa Kishimoto
- Immuno-Rheumatology Center, St Luke's International Hospital, St Luke's International University, Tokyo, Japan
| | - Ashok Kumar
- Department of Rheumatology, Fortis Flt. Lt. Rajan Dhall Hospital, New Delhi, India
| | - Khai Pang Leong
- Department of Rheumatology, Allergy and Immunology, Tan Tock Seng Hospital, Singapore, Singapore
| | - Zhanguo Li
- Department of Rheumatology and Immunology, Beijing University People's Hospital, Beijing, China
| | - Juan Javier Lichauco
- Rheumatology, Allergy and Immunology Center, St. Luke's Medical Center, Quezon City, Philippines
| | - Worawit Louthrenoo
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
| | - Shue Fen Luo
- Department of Rheumatology, Allergy, Immunology, Chang Gung Memorial Hospital, Taipei, Taiwan
| | - Rong Mu
- Department of Rheumatology and Immunology, Beijing University People's Hospital, Beijing, China
| | - Peter Nash
- Department of Medicine, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia
| | - Chin Teck Ng
- Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore.,Duke-NUS Medical School, Singapore, Singapore
| | - Bagus Suryana
- Department of Internal Medicine, Faculty of Medicine, Brawijaya University, Malang, Indonesia
| | | | - Swan Sim Yeap
- Department of Medicine, Subang Jaya Medical Centre, Subang Jaya, Malaysia
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Pisaturo M, Di Caprio G, Calò F, Portunato F, Martini S, Coppola N. Management of HBV reactivation in non-oncological patients. Expert Rev Anti Infect Ther 2019; 16:611-624. [PMID: 30058401 DOI: 10.1080/14787210.2018.1505501] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
INTRODUCTION HBV reactivation (HBVr) in patients undergoing immunosuppressive therapy is a well-known event. While there are clear directives on the management of current or resolved HBV infection in onco-hematological diseases, there are few data regarding patients with non-oncological diseases. Thus, the aim of the present review is to evaluate HBVr in patients with non-oncological diseases, and identify the management of these patients to prevent HBVr. Areas covered: Original papers, case reports and meta-analyses reporting data on HBVr of current or resolved infection in gastrointestinal, dermatological, rheumatologic and neurological diseases were evaluated. Expert commentary: In HBsAg-positive subjects, those with HBV-related hepatitis (both HBeAg-positive or negative) should be treated with a high genetic barrier nucleos(t)ide analog. The patients with HBV-infection (both HBeAg-positive and negative) an antiviral prophylaxis should be used, with lamivudine in those HBeAg-negative without signs of advanced liver disease, and with ETV, TDF or TAF in all the HBeAg-positive or in those HBeAg-negative with signs of advanced liver disease. In HBsAg-negative/anti-HBc positive subjects, when the risk of HBV reactivation is moderate (use of B-cell depleting agents), a prophylaxis-strategy may be considered; instead, in those with low risk of HBVr, a pre-emptive therapy strategy may be used.
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Affiliation(s)
- Mariantonietta Pisaturo
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy
| | - Giovanni Di Caprio
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy
| | - Federica Calò
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy
| | - Federica Portunato
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy
| | - Salvatore Martini
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy.,b Section of Infectio us Diseases , A.O.R.N. Dei Colli, Cotugno Hospital , Napoli , Italy
| | - Nicola Coppola
- a Department of Mental Health and Public Medicine, Section of Infectious Diseases , University of Campania , Naples , Italy.,c Section of Infectious Diseases , A.O.R.N S.Anna S. Sebastiano Caserta , Caserta , Italy
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Arora A, Anand AC, Kumar A, Singh SP, Aggarwal R, Dhiman RK, Aggarwal S, Alam S, Bhaumik P, Dixit VK, Goel A, Goswami B, Kumar A, Kumar M, Madan K, Murugan N, Nagral A, Puri AS, Rao PN, Saraf N, Saraswat VA, Sehgal S, Sharma P, Shenoy KT, Wadhawan M. INASL Guidelines on Management of Hepatitis B Virus Infection in Patients receiving Chemotherapy, Biologicals, Immunosupressants, or Corticosteroids. J Clin Exp Hepatol 2018; 8:403-431. [PMID: 30568345 PMCID: PMC6286881 DOI: 10.1016/j.jceh.2018.06.010] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/26/2018] [Accepted: 06/10/2018] [Indexed: 02/09/2023] Open
Abstract
Hepatitis B Virus (HBV) reactivation in patients receiving chemotherapy, biologicals, immunosupressants, or corticosteroids is emerging to be an important cause of morbidity and mortality in patients with current or prior exposure to HBV infection. These patients suffer a dual onslaught of illness: one from the primary disease for which they are receiving the culprit drug that led to HBV reactivation, and the other from HBV reactivation itself. The HBV reactivation not only leads to a compromised liver function, which may culminate into hepatic failure; it also adversely impacts the treatment outcome of the primary illness. Hence, identification of patients at risk of reactivation before starting these drugs, and starting treatment aimed at prevention of HBV reactivation is the best strategy of managing these patients. There are no Indian guidelines on management of HBV infection in patients receiving chemotherapy, biologicals, immunosupressants, or corticosteroids for the treatment of rheumatologic conditions, malignancies, inflammatory bowel disease, dermatologic conditions, or solid-organ or bone marrow transplantation. The Indian National Association for Study of the Liver (INASL) had set up a taskforce on HBV in 2016, with a mandate to develop consensus guidelines for management of various aspects of HBV infection, relevant to India. In 2017 the taskforce had published the first INASL guidelines on management of HBV infection in India. In the present guidelines, which are in continuation with the previous guidelines, the issues on management of HBV infection in patients receiving chemotherapy, biologicals, immunosupressants, or corticosteroids are addressed.
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Key Words
- ACLF, Acute-on-Chronic Liver Failure
- AFP, Alphafetoprotein
- ALT, Alanine Aminotransferase
- Anti-HBc, Antibodies to Hepatitis B Core Antigen
- Anti-HBs, Antibodies to Hepatitis B Surface Antigen
- CHB, Chronic Hepatitis B
- CHOP, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
- CKD, Chronic Kidney Disease
- DILI, Drug-Induced Liver Injury
- DNA, Deoxyribonucleic Acid
- ETV, Entecavir
- GRADE, Grading of Recommendations, Assessment, Development and Evaluation
- HAV, Hepatitis A Virus
- HBIG, Hepatitis B Immune Globulin
- HBV DNA, Hepatitis B Virus Deoxyribonucleic Acid
- HBV, Hepatitis B Virus
- HBcAg, Hepatitis B Core Antigen
- HBeAg, Hepatitis B Envelope Antigen
- HBsAg, Hepatitis B Surface Antigen
- HDV, Hepatitis D Virus
- HEV, Hepatitis E Virus
- HLA, Human Leukocyte Antigen Class I
- INASL, Indian National Association for Study of the Liver
- LAM, Lamivudine
- NAs, Nucleos(t)ide Analogs
- NHL, Non-Hodgkin’s Lymphoma
- NK, Natural Killer
- PegIFN-α, Pegylated Interferon Alpha
- RA, Rheumatoid Arthritis
- SLE, Systemic Lupus Erythematosus
- TAF, Tenofovir Alafenamide
- TDF, Tenofovir Disoproxil Fumarate
- TLC, Total Leucocyte Count
- ULN, Upper Limit of Normal
- cancer
- cccDNA, Covalently Closed Circular Deoxyribonucleic Acid
- chemotherapy
- hepatitis B
- immunosupressants
- liver failure
- rcDNA, Relaxed-Circular Deoxyribonucleic Acid
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Affiliation(s)
- Anil Arora
- Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, New Delhi, India
| | | | - Ashish Kumar
- Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, New Delhi, India
| | - Shivaram P. Singh
- Department of Gastroenterology, S.C.B. Medical College, Cuttack, India
| | - Rakesh Aggarwal
- Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Radha K. Dhiman
- Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Shyam Aggarwal
- Department of Medical Oncology, Sir Ganga Ram Hospital, New Delhi, India
| | - Seema Alam
- Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Pradeep Bhaumik
- Department of Medicine, Agartala Govt. Medical College (AGMC), Agartala, India
| | - Vinod K. Dixit
- Department of Gastroenterology, Institute of Medical Sciences Banaras Hindu University, Varanasi, India
| | - Ashish Goel
- Department of Hepatology, Christian Medical College, Vellore, India
| | - Bhabadev Goswami
- Department of Gastoenterology, Gauhati Medical College, Guwahati, India
| | - Ashok Kumar
- Department of Rheumatology, Fortis Flt Lt Rajan Dhall Hospital, New Delhi, India
| | - Manoj Kumar
- Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Kaushal Madan
- Gastroenterology & Hepatology, Max Smart Super Speciality Hospital, New Delhi, India
| | | | - Aabha Nagral
- Department of Gastroenterology, Jaslok and Apollo Hospitals, Mumbai, India
| | - Amarender S. Puri
- Department of Gastroenterology, G.B. Pant Hospital, New Delhi, India
| | - Padaki N. Rao
- Hepatology, Asian Institute Of Gastroenterology, Hyderabad, India
| | - Neeraj Saraf
- Hepatology, Medanta - The Medicity, Gurugram, India
| | - Vivek A. Saraswat
- Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
| | - Sanjeev Sehgal
- Institute of Liver Transplantation and Regenerative Medicine, Medanta - The Medicity, Gurugram, India
| | - Praveen Sharma
- Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, New Delhi, India
| | | | - Manav Wadhawan
- Hepatology & Liver Transplant (Medicine), Fortis Escorts Liver & Digestive Diseases Institute (FELDI), Fortis Escorts Hospital, Delhi, India
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Su J, Long L, Zou K. Antiviral prophylaxis for preventing reactivation of hepatitis B virus in rheumatic patients: a systematic review and meta-analysis. Clin Rheumatol 2018; 37:3201-3214. [PMID: 29637482 DOI: 10.1007/s10067-018-4096-0] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2017] [Revised: 02/26/2018] [Accepted: 04/02/2018] [Indexed: 02/06/2023]
Abstract
To estimate the risk of reactivation of hepatitis B virus (HBV) and evaluate the effectiveness of antiviral prophylaxis (AVP) in patients with different status of HBV infection undergoing antirheumatic therapies. We searched Cochrane Library, Medline, and EMBASE for randomized controlled trials (RCTs), quasi-RCTs, non-RCTs, cohort studies, or case series studies examining reactivation of HBV in patients undergoing antirheumatic therapy with or without AVP. We estimated the HBV reactivation rate (HRR) and its 95% confidence interval (CI) among different patient groups (indirect comparison). We also calculated rate ratio (RR), rate difference (RD) with their 95% CIs, and the number needed to treat (NNT) of AVP (direct comparison). Fifty-three case series studies with 2162 patients were included. The RD of AVP was - 0.13 (95% CI - 0.21 to - 0.05) for all patients, - 0.16 (95% CI - 0.26 to - 0.06) for rheumatic patients with chronic HBV infection, but not statistically significant for patients with other status of HBV infection. Lamivudine (RD - 0.10, 95% CI - 0.25 to 0.05) was less effective than other prophylactic antiviral drugs (RD - 0.31, 95% CI - 0.52 to - 0.11). The HHR varied from 55 to 5% by HBV status and treatment. There is limited evidence that AVP was effective for preventing reactivation of HBV in patients undergoing antirheumatic therapy. The effectiveness varies by patient HBV status and antiviral regimens. Rheumatic HBV carriers may be more beneficial from AVP, and lamivudine may be inferior to other AVP regimens. Findings in this study warrant further investigation in rigorous RCTs.
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Affiliation(s)
- Jiang Su
- Department of Rheumatology and Immunology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Affiliated Hospital of the University of Electronic Science and Technology, Chengdu, China
| | - Li Long
- Department of Rheumatology and Immunology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Affiliated Hospital of the University of Electronic Science and Technology, Chengdu, China
| | - Kun Zou
- Department of Medical Records and Statistics, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Affiliated Hospital of the University of Electronic Science and Technology, No. 32, West Second Section, First Ring Road, Chengdu, China.
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Pauly MP, Tucker LY, Szpakowski JL, Ready JB, Baer D, Hwang J, Lok ASF. Incidence of Hepatitis B Virus Reactivation and Hepatotoxicity in Patients Receiving Long-term Treatment With Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol 2018; 16:1964-1973.e1. [PMID: 29702293 DOI: 10.1016/j.cgh.2018.04.033] [Citation(s) in RCA: 45] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2017] [Revised: 03/13/2018] [Accepted: 04/13/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Tumor necrosis factor (TNF) antagonists are the first-line treatment for many autoimmune diseases. However, they have been associated with reactivation of hepatitis B virus (HBV). We determined the rate of HBV reactivation and hepatotoxicity grade 3 or 4 (HT ≥3) in patients treated with an anti-TNF agent for an autoimmune disease. METHODS We collected data from 8887 adult patients in the Kaiser Permanente Northern California database who began treatment with TNF antagonists for autoimmune diseases (dermatologic, rheumatologic, or gastrointestinal) from 2001 through 2010, followed through December 2012. We obtained data on HBV infection (52% of patients were screened for HBV before treatment), demographic features, comorbidities, and use of immunosuppressive agents. HBV reactivation was defined as 1 of the following: >1 log increase in HBV DNA, HBV DNA-positive when previously negative, HBV DNA >2000 IU/mL if no baseline level was available, or reverse seroconversion. HT ≥3 was defined according to the National Cancer Institute Common Toxicity Criteria. We performed multivariable logistic regression to identify factors associated with HT ≥3. RESULTS Twenty-three patients tested positive for HB surface antigen (HBsAg) at baseline and 9 of these had HBV reactivation; of the 4267 patients with unknown HBV status at baseline, 2 had HBV reactivation. None of the 178 patients who were HBsAg negative and positive for the hepatitis B core antibody (anti-HBc+) had HBV reactivation. HBV reactivation occurred in 1/5 HBsAg+ patients who received prophylactic antiviral therapy and 8/18 who did not (P = .61). No one with HBV reactivation had liver failure. HT ≥3 occurred in 273 patients (2.7%), but only 3 cases were attributed to HBV. Cirrhosis was significantly associated with HT ≥3 (P < .001). CONCLUSION In a retrospective analysis of patients treated with TNF antagonists for autoimmune diseases, we found HBV reactivation in 39% of patients who were HBsAg+ before therapy, but not in any patients who were HBsAg-negative and anti-HBc+ before therapy. Patients should be screened for HBV infection before anti-TNF therapy; HBsAg+ patients should receive prophylactic antiviral therapy, but not HBsAg-negative, anti-HBc+ patients.
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Affiliation(s)
- Mary Patricia Pauly
- Department of Gastroenterology, Kaiser Permanente Northern California, Sacramento, California.
| | - Lue-Yen Tucker
- Division of Research, Kaiser Permanente Northern California, Sacramento, California
| | - Jean-Luc Szpakowski
- Department of Gastroenterology, Kaiser Permanente Northern California, Sacramento, California
| | - Joanna B Ready
- Department of Gastroenterology, Kaiser Permanente Northern California, Sacramento, California
| | - David Baer
- Department of Hematology and Oncology, Kaiser Permanente Northern California, Sacramento, California
| | - Jessica Hwang
- Department of General Internal Medicine, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Anna S-F Lok
- Department of Internal Medicine and Gastroenterology, University of Michigan, Ann Arbor, Michigan
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Niccoli L, Nannini C, Blandizzi C, Mantarro S, Mosca M, Di Munno O, Goletti D, Benucci M, Gobbi FL, Cassarà E, Kaloudi O, Cantini F. Personalization of biologic therapy in patients with rheumatoid arthritis: less frequently accounted choice-driving variables. Ther Clin Risk Manag 2018; 14:2097-2111. [PMID: 30498353 PMCID: PMC6207089 DOI: 10.2147/tcrm.s175772] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023] Open
Abstract
Objective To propose appropriate statements that drive the choice of biologic therapies in patients with rheumatoid arthritis (RA), factoring in their impact on the following issues: anti-drug antibody (ADAb) formation, suspicion and management of infections, lupus-like syndrome (LLS), effects on bone mass and sexual sphere, and relationship between RA and periodontal disease (PD). Methods An overview of existing evidence was undertaken by an expert panel on behalf of the Italian board for the TAilored BIOlogic therapy (ITABIO). Data were extracted from controlled trials, national registries, national health care databases, post-marketing surveys, and, when required by the paucity of controlled studies, from open-label clinical series. Anti-tumor necrosis factor (anti-TNF) and non-anti-TNF-targeted biologics approved for RA were investigated. Results ADAb formation is chiefly associated with anti-TNFs, and it is reduced by combination therapy with methotrexate. To date, ADAb titration is not advisable for clinical practice, and, in case of anti-TNF secondary failure, a non-anti-TNF biologic is indicated. LLS is observed in anti-TNF receivers and, in most cases, resolves without anti-TNF withdrawal. A non-anti-TNF biologic is advisable in patients experiencing LLS. Non-anti-TNFs demonstrated a low or absent infection risk and are preferable in patients with comorbidities. Due to their positive effects on bone mass, anti-TNFs are indicated in women at osteoporosis risk, whereas non-anti-TNF have been poorly investigated. The emerging evidence of the relationship between RA and PD and the effects on anti-TNF efficacy should lead clinicians to consider the periodontal status in RA patients. Anti-TNFs may exert a positive effect on fertility and sexuality, and clinicians should explore these aspects in RA patients. Conclusion The optimization of biologic therapies by taking into proper account the above issues would improve patient outcomes.
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Affiliation(s)
- Laura Niccoli
- Department of Rheumatology, Hospital of Prato, Prato, Italy,
| | | | - Corrado Blandizzi
- Section of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Stefania Mantarro
- Section of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Marta Mosca
- Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Ombretta Di Munno
- Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
| | - Delia Goletti
- Translational Research Unit, Department of Epidemiology and Preclinical Research, National Institute for Infectious Diseases, Rome, Italy
| | | | | | | | - Olga Kaloudi
- Department of Rheumatology, Hospital of Prato, Prato, Italy,
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Holroyd CR, Seth R, Bukhari M, Malaviya A, Holmes C, Curtis E, Chan C, Yusuf MA, Litwic A, Smolen S, Topliffe J, Bennett S, Humphreys J, Green M, Ledingham J. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis. Rheumatology (Oxford) 2018; 58:e3-e42. [DOI: 10.1093/rheumatology/key208] [Citation(s) in RCA: 64] [Impact Index Per Article: 9.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2018] [Indexed: 12/31/2022] Open
Affiliation(s)
- Christopher R Holroyd
- Rheumatology Department, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Rakhi Seth
- Rheumatology Department, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Marwan Bukhari
- Rheumatology Department, University Hospitals of Morecombe Bay NHS Foundation Trust, Lancaster, UK
| | - Anshuman Malaviya
- Rheumatology Department, Mid Essex hospitals NHS Trust, Chelmsford, UK
| | - Claire Holmes
- Rheumatology Department, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Elizabeth Curtis
- MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK
| | - Christopher Chan
- Rheumatology Department, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Mohammed A Yusuf
- Rheumatology Department, Mid Essex hospitals NHS Trust, Chelmsford, UK
| | - Anna Litwic
- MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK
- Rheumatology Department, Salisbury District Hospital, Salisbury, UK
| | - Susan Smolen
- Rheumatology Department, Mid Essex hospitals NHS Trust, Chelmsford, UK
| | - Joanne Topliffe
- Rheumatology Department, Mid Essex hospitals NHS Trust, Chelmsford, UK
| | - Sarah Bennett
- Rheumatology Department, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Jennifer Humphreys
- Arthritis Research UK Centre for Epidemiology, University of Manchester, Manchester, UK
| | - Muriel Green
- National Rheumatoid Arthritis Society, Queen Alexandra Hospital, Portsmouth, UK
| | - Jo Ledingham
- Rheumatology Department, Queen Alexandra Hospital, Portsmouth, UK
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Lin TC, Yoshida K, Tedeschi SK, de Abreu MM, Hashemi N, Solomon DH. Risk of Hepatitis B Virus Reactivation in Patients With Inflammatory Arthritis Receiving Disease-Modifying Antirheumatic Drugs: A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken) 2018; 70:724-731. [PMID: 28834412 DOI: 10.1002/acr.23346] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2017] [Accepted: 08/15/2017] [Indexed: 12/13/2022]
Abstract
OBJECTIVE To assess hepatitis B virus (HBV) reactivation rates in patients with resolved or chronic HBV infection, receiving disease-modifying antirheumatic drugs (DMARDs) and with or without antiviral prophylaxis. METHODS We conducted a systematic review and meta-analysis. Electronic searches were conducted in PubMed, Medline, and Embase using Ovid through December 31, 2015. A search strategy was developed for each database using the following inclusion criteria: for participants, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and resolved or chronic HBV infection; for intervention, tumor necrosis factor (TNF) inhibitors or non-TNF biologic or nonbiologic DMARDs; and for outcome, HBV reactivation. Four reviewers independently extracted study data and assessed study quality using the Newcastle-Ottawa Scale. To determine the pooled HBV reactivation rate, the variances of the raw proportions were stabilized using a Freeman-Tukey-type arcsine square root transformation, using a random-effects model. RESULTS Twenty-five studies met the inclusion criteria. The overall pooled rate of HBV reactivation was 1.6% (95% confidence interval [95% CI] 0.8-2.6) in patients with resolved HBV. Similar rates were observed in resolved patients taking TNF inhibitors (1.4% [95% CI 0.5-2.6]), non-TNF biologics (6.1% [95% CI 0.0-16.6]), and nonbiologic DMARDs (1.7% [95% CI 0.2-4.2]). We also found that the reactivation rate was lower in patients with chronic HBV infection who received antiviral prophylaxis (9.0% [95% CI 4.1-15.5]) than in those who did not (14.6% [95% CI 4.3-29.0]). CONCLUSION We found that the HBV reactivation rate in inflammatory arthritis patients receiving DMARDs was low in resolved patients and moderate in patients with chronic HBV infection. Further, lower rates were observed in patients with chronic HBV infection who were using antiviral prophylaxis.
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Affiliation(s)
- Tzu-Chieh Lin
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Kazuki Yoshida
- Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, Massachusetts
| | - Sara K Tedeschi
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Mirhelen Mendes de Abreu
- Universidade Federal do Rio de Janeiro and Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil
| | - Nikroo Hashemi
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Daniel H Solomon
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
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Pereira R, Raposo I, Nery F, Torres T. Risk of hepatitis B virus reactivation in patients treated with anti-TNFα agents for immune-mediated inflammatory diseases. ACTAS DERMO-SIFILIOGRAFICAS 2018. [DOI: 10.1016/j.adengl.2017.07.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
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Pereira R, Raposo I, Nery F, Torres T. Risk of hepatitis B virus reactivation in patients treated with anti-TNFα agents for immune-mediated inflammatory diseases. ACTAS DERMO-SIFILIOGRAFICAS 2018; 109:285-287. [DOI: 10.1016/j.ad.2017.07.011] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2017] [Revised: 06/06/2017] [Accepted: 07/16/2017] [Indexed: 10/18/2022] Open
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Sebastiani M, Atzeni F, Milazzo L, Quartuccio L, Scirè C, Gaeta GB, Lapadula G, Armignacco O, Tavio M, Olivieri I, Meroni P, Bazzichi L, Grassi W, Mathieu A, Mastroianni C, Sagnelli E, Santantonio T, Uberti Foppa C, Puoti M, Sarmati L, Airò P, Epis OM, Scrivo R, Gargiulo M, Riva A, Manfredi A, Ciancio G, Zehender G, Taliani G, Meroni L, Sollima S, Sarzi-Puttini P, Galli M. Prise en charge de l’infection par le virus de l’hépatite B chez les patients atteints de polyarthrite rhumatoïde : conférence de consensus italienne. REVUE DU RHUMATISME 2018; 85:115-120. [DOI: 10.1016/j.rhum.2017.09.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/05/2025]
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Lin TC, Hashemi N, Kim SC, Yang YHK, Yoshida K, Tedeschi S, Desai R, Solomon DH. Practice Pattern of Hepatitis B Testing in Rheumatoid Arthritis Patients: A Cross-National Comparison Between the US and Taiwan. Arthritis Care Res (Hoboken) 2017; 70:30-38. [PMID: 28320050 DOI: 10.1002/acr.23241] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2016] [Accepted: 03/14/2017] [Indexed: 12/19/2022]
Abstract
OBJECTIVE The hepatitis B virus (HBV) testing rates and patterns in rheumatoid arthritis (RA) patients starting disease-modifying antirheumatic drugs (DMARDs) have not been well studied. We describe and compare the practice patterns of HBV testing among RA patients in the US and Taiwan. METHODS We conducted a retrospective cohort study, including RA patients starting a first DMARD in the US or Taiwan. The first date patients newly received any DMARD was defined as the index date, and the 1-year period before the index date was the baseline period. HBV testing was defined as any of the following tests 1 year before or after the index date: hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody, hepatitis B envelope antigen, hepatitis B envelope antibody, or HBV DNA. We calculated the HBV testing rate by year and used Poisson regression to calculate the testing rate ratio. RESULTS We identified 14,568 RA patients in the US and 46,265 in Taiwan. The overall testing rate was 20.3% in the US and 24.5% in Taiwan, and gradually increased over the study period from 13.1-23.0% in the US and 16.8-30.0% in Taiwan. More than one type of HBV test was used in 43.4% of patients in the US and 16.3% of patients in Taiwan receiving tests. Results of Poisson regression found Taiwan had a 17% higher testing rate over the US during the followup period (crude rate ratio 1.17 [95% confidence interval 1.12-1.22]). CONCLUSION We found small differences in the HBV testing rates across the US and Taiwan. Although the rate gradually increased in the past decade, it remained low in both countries.
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Affiliation(s)
- Tzu-Chieh Lin
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, and National Cheng Kung UniversityTainan City, Taiwan
| | - Nikroo Hashemi
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Seoyoung C Kim
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Yea-Huei Kao Yang
- National Cheng Kung University College of Medicine, Tainan City, Taiwan
| | - Kazuki Yoshida
- Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, Massachusetts
| | - Sara Tedeschi
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Rishi Desai
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
| | - Daniel H Solomon
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
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Sebastiani M, Atzeni F, Milazzo L, Quartuccio L, Scirè C, Gaeta GB, Lapadula G, Armignacco O, Tavio M, Olivieri I, Meroni P, Bazzichi L, Grassi W, Mathieu A, Mastroianni C, Sagnelli E, Santantonio T, Uberti Foppa C, Puoti M, Sarmati L, Airò P, Epis OM, Scrivo R, Gargiulo M, Riva A, Manfredi A, Ciancio G, Zehender G, Taliani G, Meroni L, Sollima S, Sarzi-Puttini P, Galli M. Italian consensus Guidelines for the management of hepatitis B virus infections in patients with rheumatoid arthritis. Joint Bone Spine 2017; 84:525-530. [PMID: 28529116 DOI: 10.1016/j.jbspin.2017.05.013] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2017] [Accepted: 05/04/2017] [Indexed: 01/05/2023]
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Padovan M, Filippini M, Tincani A, Lanciano E, Bruschi E, Epis O, Garau P, Mathieu A, Celletti E, Giani L, Tomietto P, Atzeni F, Sarzi Puttini P, Zuliani F, De Vita S, Trotta F, Grilli A, Puoti M, Govoni M. Safety of Abatacept in Rheumatoid Arthritis With Serologic Evidence of Past or Present Hepatitis B Virus Infection. Arthritis Care Res (Hoboken) 2017; 68:738-43. [PMID: 26555747 DOI: 10.1002/acr.22786] [Citation(s) in RCA: 38] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2015] [Revised: 09/08/2015] [Accepted: 11/03/2015] [Indexed: 12/19/2022]
Abstract
OBJECTIVE Rheumatoid arthritis (RA) with concomitant hepatitis B virus (HBV) infection represents a therapeutic challenge due to the risk of HBV reactivation under immunosuppressive treatment. To date there are few data coming from anecdotal case reports that concern HBV reactivation following treatment with abatacept. This observational retrospective study was aimed to assess the safety profile of abatacept in this particular clinical setting. METHODS Eleven Italian rheumatologic centers provided data from patients with RA and positive HBV serology treated with intravenous abatacept. HBV markers and clinical and laboratory data were checked at followup visits every 3 months. RESULTS In total, 72 patients were included in the study: 47 inactive carriers, 21 occult carriers, and 4 chronic active carriers for HBV. At baseline all of the patients had normal liver function tests and low or undetectable HBV DNA levels, except for those with chronic active hepatitis. Thirteen patients received prophylaxis with lamivudine, and 4 received treatment with adefovir or tenofovir. At the end of the 24-month followup period, 49 patients were being treated. Data from 316 followup visits showed that abatacept was safe. No patients experienced reactivation of hepatitis B. Treatment withdrawals (23 patients) were due to lack of efficacy, subject decision/lost at followup, or adverse events not related to HBV infection. CONCLUSION Our study provides reassuring data about the safety profile of abatacept in RA with concomitant HBV infection without universal antiviral prophylaxis. Further prospective studies are needed to confirm these preliminary results.
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Affiliation(s)
- Melissa Padovan
- Università degli studi di Ferrara and Azienda Ospedaliero Universitaria S. Anna di Ferrara, Ferrara, Italy
| | | | | | | | | | - Oscar Epis
- A. O. Ospedale Niguarda Cà Granda, Milano, Italy
| | - Pietro Garau
- Policlinico Universitario Monserrato, Cagliari, Italy
| | | | | | | | - Paola Tomietto
- Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste, Trieste, Italy
| | | | | | | | | | - Francesco Trotta
- Università degli studi di Ferrara and Azienda Ospedaliero Universitaria S. Anna di Ferrara, Ferrara, Italy
| | - Anastasio Grilli
- Università degli studi di Ferrara and Azienda Ospedaliero Universitaria S. Anna di Ferrara, Ferrara, Italy
| | | | - Marcello Govoni
- Università degli studi di Ferrara and Azienda Ospedaliero Universitaria S. Anna di Ferrara, Ferrara, Italy
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Cannizzaro MV, Franceschini C, Esposito M, Bianchi L, Giunta A. Hepatitis B reactivation in psoriasis patients treated with anti-TNF agents: prevention and management. PSORIASIS-TARGETS AND THERAPY 2017; 7:35-40. [PMID: 29387606 PMCID: PMC5774605 DOI: 10.2147/ptt.s108209] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
The risk of hepatitis B virus (HBV) reactivation (HBVr) in chronic HBV carriers, in occult HBV patients or in acute HBV patients affected by psoriasis and treated with anti-tumor necrosis factor (TNF)-α agents is a clinical practice issue to face with, particularly if the treatment has a long-term maintenance finality. The aims of this review are to examine the current knowledge on HBVr incidence in chronic HBV carriers and potential occult carriers undergoing therapy with biologics for the treatment of psoriasis and psoriatic arthritis; analyze the prophylactic measure to prevent HBV reactivation and define how to manage HBVr in patients treated with biologics. We searched through PubMed, Google Scholar and Scopus databases and evaluated all published manuscripts concerning HBVr in psoriatic patients, both plaque-type and psoriatic arthritis, in treatment with any indicated anti-TNF-α. Although anti-TNFs are considered moderate immunosuppressive drugs, the incidence of HBVr in psoriatic patients is lower compared to patients affected by other immune-mediated diseases treated with TNF inhibitors. HBV prophylaxis should be probably reserved to anti-HBs+/anti-HBc+ patients with a viral load <2000 IU/mL and alterations in serum liver enzymes, in order to prevent HBVr.
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Affiliation(s)
| | | | - Maria Esposito
- Department of Dermatology, University of Rome Tor Vergata, Rome, Italy
| | - Luca Bianchi
- Department of Dermatology, University of Rome Tor Vergata, Rome, Italy
| | - Alessandro Giunta
- Department of Dermatology, University of Rome Tor Vergata, Rome, Italy
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Braun J, Kay J. The safety of emerging biosimilar drugs for the treatment of rheumatoid arthritis. Expert Opin Drug Saf 2017; 16:289-302. [PMID: 28068848 DOI: 10.1080/14740338.2017.1273899] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
INTRODUCTION Biological disease-modifying anti-rheumatic drugs (bDMARDs), often administered in combination with methotrexate, target specific inflammatory mediators and have transformed the treatment of rheumatic diseases, especially rheumatoid arthritis (RA) but also the spondyloarthritides. However, the high cost of these drugs in many countries restricts patient access. As many bDMARDs have reached or are near to patent expiration, numerous biosimilar drugs are in development and some have already been approved. Biosimilars are generally priced lower than their reference products (RPs), or bio-originators, and as prices come down it is hoped that patient access to these drugs will increase, making the safety of these drugs an area of major interest. Areas covered: This article reviews publicly available safety data on biosimilars in RA. Expert opinion: Most available data for biosimilars in RA relate to tumor necrosis factor inhibitors (TNFi) and rituximab (an anti-CD20 monoclonal antibody). As biosimilar use around the world increases, evidence supporting the clinical safety of the biosimilars compared with their RPs also grows. To date, no new safety concerns have been raised in studies with TNFi or rituximab biosimilars for the treatment of RA; safety profiles have been consistent with those of their RPs. However, careful post-marketing pharmacovigilance remains necessary.
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Affiliation(s)
- J Braun
- a Rheumazentrum Ruhrgebiet , Herne , Germany
| | - J Kay
- b Division of Rheumatology, Department of Medicine , UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester , MA , USA
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Krasselt M, Ivanov JP, Baerwald C, Seifert O. Low vaccination rates among patients with rheumatoid arthritis in a German outpatient clinic. Rheumatol Int 2016; 37:229-237. [DOI: 10.1007/s00296-016-3608-y] [Citation(s) in RCA: 32] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2016] [Accepted: 11/15/2016] [Indexed: 12/22/2022]
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Bonifati C, Lora V, Graceffa D, Nosotti L. Management of psoriasis patients with hepatitis B or hepatitis C virus infection. World J Gastroenterol 2016; 22:6444-6455. [PMID: 27605880 PMCID: PMC5006156 DOI: 10.3748/wjg.v22.i28.6444] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2016] [Revised: 05/25/2016] [Accepted: 06/15/2016] [Indexed: 02/06/2023] Open
Abstract
The systemic therapies available for the management of Psoriasis (PsO) patients who cannot be treated with more conservative options, such as topical agents and/or phototherapy, with the exception of acitretin, can worsen or reactivate a chronic infection. Therefore, before administering immunosuppressive therapies with either conventional disease-modifying drugs (cDMARDs) or biological ones (bDMARDs) it is mandatory to screen patients for some infections, including hepatitis B virus (HBV) and hepatitis C virus (HCV). In particular, the patients eligible to receive an immunosuppressive drug must be screened for the following markers: antibody to hepatitis B core, antibody to hepatitis B surface antigen (anti-HBsAg), HBsAg, and antibody to HCV (anti-HCV). In case HBV or HCV infection is diagnosed, a close collaboration with a consultant hepatologist is needed before and during an immunosuppressive therapy. Concerning therapy with immunosuppressive drugs in PsO patients with HBV or HCV infection, data exist mainly for cyclosporine a (CyA) or bDMARDs (etanercept, adalimumab, infliximab, ustekinumab). The natural history of HBV and HCV infection differs significantly as well as the effect of immunosuppression on the aforementioned infectious diseases. As a rule, in the case of active HBV infection, systemic immunosuppressive antipsoriatic therapies must be deferred until the infection is controlled with an adequate antiviral treatment. Inactive carriers need to receive antiviral prophylaxis 2-4 wk before starting immunosuppressive therapy, to be continued after 6-12 mo from its suspension. Due to the risk of HBV reactivation, these patients should be monitored monthly for the first 3 mo and then every 3 mo for HBV DNA load together with transaminases levels. Concerning the patients who are occult HBV carriers, the risk of HBV reactivation is very low. Therefore, these patients generally do not need antiviral prophylaxis and the sera HBsAg and transaminases dosing can be monitored every 3 mo. Concerning PsO patients with chronic HCV infection their management with immunosuppressive drugs is less problematic as compared to those infected by HBV. In fact, HCV reactivation is an extremely rare event after administration of drugs such as CyA or tumor necrosis factor-α inhibitors. As a rule, these patients can be monitored measuring HCV RNA load, and ALT, aspartate transaminase, gamma-glutamyl-transferase, bilirubin, alkaline phosphatase, albumin and platelet every 3-6 mo. The present article provides an updated overview based on more recently reported data on monitoring and managing PsO patients who need systemic antipsoriatic treatment and have HBV or HCV infection as comorbidity.
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Viganò M, Serra G, Casella G, Grossi G, Lampertico P. Reactivation of hepatitis B virus during targeted therapies for cancer and immune-mediated disorders. Expert Opin Biol Ther 2016; 16:917-26. [PMID: 27088278 DOI: 10.1080/14712598.2016.1177017] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
INTRODUCTION Targeted therapies have gained popularity in the treatment of several oncologic and immune-mediated diseases. Immunosuppression caused by these drugs has been associated to reactivation of hepatitis B virus (HBV) in both hepatitis B surface antigen (HBsAg) positive patients (overt infection) and HBsAg negative/anti-hepatitis B core antigen (anti-HBc) positive carriers (resolved infection), leading to premature discontinuation of therapy and potentially fatal hepatitis. AREAS COVERED This review summarizes the evidence of HBV reactivation in patients with overt or resolved HBV infection undergoing targeted therapies for cancer or immune-mediated disorders, providing recommendations for the management of these patients. EXPERT OPINION The risk of HBV reactivation relies on the immunosuppressive potency and duration of these therapies, the underlying disease and the virological patient's profile. However, HBV reactivation is preventable by screening for HBV markers in all patients scheduled to receive targeted therapies, assessing the virological profile and patient's clinical state, followed by appropriate antiviral treatment or prophylaxis in those patients at high risk of HBV reactivation. Close monitoring of HBV carriers at low risk of reactivation is warranted with the aim to start antiviral therapy as soon as HBV reactivates.
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Affiliation(s)
- Mauro Viganò
- a Hepatology Unit, Ospedale San Giuseppe , Università di Milano , Milan , Italy
| | | | | | - Glenda Grossi
- c A.M. and A. Migliavacca" Center for Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico , Università di Milano , Milan , Italy
| | - Pietro Lampertico
- c A.M. and A. Migliavacca" Center for Liver Disease, Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico , Università di Milano , Milan , Italy
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Mallet V, van Bömmel F, Doerig C, Pischke S, Hermine O, Locasciulli A, Cordonnier C, Berg T, Moradpour D, Wedemeyer H, Ljungman P. Management of viral hepatitis in patients with haematological malignancy and in patients undergoing haemopoietic stem cell transplantation: recommendations of the 5th European Conference on Infections in Leukaemia (ECIL-5). THE LANCET. INFECTIOUS DISEASES 2016; 16:606-617. [PMID: 27599653 DOI: 10.1016/s1473-3099(16)00118-3] [Citation(s) in RCA: 103] [Impact Index Per Article: 11.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/07/2015] [Revised: 02/11/2016] [Accepted: 02/12/2016] [Indexed: 12/24/2022]
Abstract
Viral hepatitis affects millions of people worldwide, and host immunity is the key determinant of patient outcome. Viral hepatitis can be life threatening in patients with haematological malignancy, including haemopoietic stem cell transplant recipients, because of the virus itself, or through a need to decrease the dose of chemotherapy. A past or currently infected haemopoietic stem cell donor could also transmit viral hepatitis. The burden of viral hepatitis in patients with haematological malignancies and the weak evidence on which previous guidelines are based has prompted the European Conference on Infection in Leukaemia (ECIL-5) to convene a group of experts in the fields of viral hepatitis and of haematological malignancy to specifically address previously unconsidered issues and grade the available quality of evidence according to the Infectious Diseases Society of America grading system. The group recommends that all patients should be screened for hepatotropic viruses before haematological treatment and that patients or haemopoietic stem cell donors with markers of past or current viral hepatitis should be assessed by an expert. Screening, vaccination, and treatment rules are reported in this Review.
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Affiliation(s)
- Vincent Mallet
- Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Institut Pasteur, Institut National de la Santé et de la Recherche Médicale Unité 1223, Paris, France; Hepatology Service, Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Cochin Port-Royal, Paris, France.
| | | | - Christopher Doerig
- Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland
| | - Sven Pischke
- University Medical Center Hamburg-Eppendorf, First Department of Medicine, Hamburg, Germany
| | - Olivier Hermine
- Department of Haematology, Paris Descartes University, Imagine Institute, Necker Hospital, Paris, France
| | - Anna Locasciulli
- Ematologia e Trapianto di Midollo, Ospedale SanCamillo, Roma, Italia
| | - Catherine Cordonnier
- Haematology Department, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, and Paris-Est Créteil University, Créteil, France
| | - Thomas Berg
- Hepatology Section, University Hospital Leipzig, Leipzig, Germany
| | - Darius Moradpour
- Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland
| | | | - Per Ljungman
- Karolinska University Hospital, Department of Haematology and Karolinska Institutet, Department of Medicine, Huddinge, Stockholm, Sweden
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North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol 2016; 226:24-34. [PMID: 27015977 DOI: 10.1016/j.jbiotec.2016.03.032] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2015] [Revised: 03/15/2016] [Accepted: 03/21/2016] [Indexed: 01/08/2023]
Abstract
Innate Defense Regulators (IDRs) are short synthetic peptides that target the host innate immune system via an intracellular adaptor protein which functions at key signaling nodes. In this work, further details of the mechanism of action of IDRs have been discovered. The studies reported here show that the lead clinical IDR, SGX94, has broad-spectrum activity against Gram-negative and Gram-positive bacterial infections caused by intracellular or extracellular bacteria and also complements the actions of standard of care antibiotics. Based on in vivo and primary cell culture studies, this activity is shown to result from the primary action of SGX94 on tissue-resident cells and subsequent secondary signaling to activate myeloid-derived cells, resulting in enhanced bacterial clearance and increased survival. Data from non-clinical and clinical studies also show that SGX94 treatment modulates pro-inflammatory and anti-inflammatory cytokine levels, thereby mitigating the deleterious inflammatory consequences of innate immune activation. Since they act through host pathways to provide both broad-spectrum anti-infective capability as well as control of inflammation, IDRs are unlikely to be impacted by resistance mechanisms and offer potential clinical advantages in the fight against emerging and antibiotic resistant bacterial infections.
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Affiliation(s)
- John R North
- Inimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada
| | - Shunsuke Takenaka
- Inimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada
| | - Annett Rozek
- Inimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada
| | | | - Steven Opal
- The Warren Alpert Medical School of Brown University, Pawtucket, RI 02912, United States
| | - Lisa A Morici
- Tulane University School of Medicine, 1430 Tulane Avenue #8010, New Orleans, LA 70112, United States
| | - B Brett Finlay
- University of British Columbia, Vancouver, BC V6T 1Z4, Canada
| | | | - Richard Straube
- Soligenix Inc., 29 Emmons Drive, Suite C-10, Princeton, NJ, 08540, United States
| | - Oreola Donini
- Inimex Pharmaceuticals Inc., 8540 Baxter Place, Burnaby, BC V5A 4T8, Canada; Soligenix Inc., 29 Emmons Drive, Suite C-10, Princeton, NJ, 08540, United States.
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Colitis ulcerosa asociada a pancreatitis autoinmune, sialoadenitis y vasculitis leucocitoclástica. GASTROENTEROLOGIA Y HEPATOLOGIA 2016; 39:214-6. [DOI: 10.1016/j.gastrohep.2015.02.004] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/27/2014] [Revised: 01/27/2015] [Accepted: 02/13/2015] [Indexed: 12/16/2022]
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