Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Dec 26, 2021; 9(36): 11285-11299
Published online Dec 26, 2021. doi: 10.12998/wjcc.v9.i36.11285
Real-world data on the infliximab biosimilar CT-P13 (Remsima®) in inflammatory bowel disease
Jose María Huguet, Xavier Cortés, Marta Maia Bosca-Watts, Marian Aguas, Nuria Maroto, Lidia Martí, Cirilo Amorós, Jose María Paredes
Jose María Huguet, Department of Gastroenterology, General University Hospital of Valencia, Valencia 46014, Spain
Xavier Cortés, Department of Gastroenterology, Hospital de Sagunto, Sagunto 46520, Spain
Marta Maia Bosca-Watts, Department of Gastroenterology, Hospital Clinico Universitario de Valencia, Valencia 46010, Spain
Marian Aguas, Department of Gastroenterology, Hospital Universitario y Politecnico la Fe de Valencia, Valencia 46026, Spain
Nuria Maroto, Department of Gastroenterology, Hospital de Manises, Manises 46940, Spain
Lidia Martí, Department of Gastroenterology, Hospital Comarcal Francesc de Borja, Gandia 46702, Spain
Cirilo Amorós, Department of Gastroenterology, Hospital Arnau de Vilanova de Valencia, Valencia 46015, Spain
Jose María Paredes, Department of Gastroenterology, Hospital Universitario Doctor Peset de Valencia, Valencia 46017, Spain
Author contributions: Huguet JM contributed to conceptualization, data curation, formal analysis, methodology, visualization, and writing of the original draft; all authors shared the responsibility for acquiring funding, as well as writing, reviewing, editing, and approval of the final manuscript.
Institutional review board statement: The study was approved by the Hospital General Universitario de Valencia Ethics Committee.
Informed consent statement: Informed consents were obtained from all individual participants included in the study.
Conflict-of-interest statement: Jose M Huguet declares educational activities, research projects, scientific meetings, and advisory boards sponsored by MSD, Ferring, AbbVie, Janssen, Biogen, Sandoz, Kern Pharma, and Takeda. Marta Maia Bosca-Watts declares educational activities, research projects, scientific meetings, and advisory boards sponsored by MSD, Ferring, AbbVie, Janssen, Biogen and Takeda. Marian Aguas has received speaker's honoraria from MSD and Pfizer. Nuria Maroto declares educational activities, research projects, scientific meetings, and advisory boards sponsored by MSD, AbbVie, Takeda, and Ferring. Jose María Paredes declares educational activities, research projects, scientific meetings, and advisory boards sponsored by Takeda, AbbVie, MSD, and Janssen. Xavier Cortés, Lidia Martí, and Cirilo Amorós declare that they have no conflicts of interest.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement–checklist of items, and the manuscript was prepared and revised according to the STROBE Statement–checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jose María Huguet, MD, Reader (Associate Professor), Department of Gastroenterology, General University Hospital of Valencia, Av Tres cruces, Valencia 46014, Spain. josemahuguet@gmail.com
Received: April 22, 2021
Peer-review started: April 22, 2021
First decision: May 24, 2021
Revised: June 4, 2021
Accepted: July 2, 2021
Article in press: July 2, 2021
Published online: December 26, 2021
Processing time: 244 Days and 17.3 Hours
Abstract
BACKGROUND

In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients’ access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD.

AIM

To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.

METHODS

An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naïve to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo.

RESULTS

A total of 220 IBD patients treated with CT-P13 (Remsima®) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn’s disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naïve to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious.

CONCLUSION

CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.

Keywords: Crohn’s disease; Ulcerative colitis; Inflammatory bowel disease; Infliximab; Biosimilar; CT-P13

Core Tip: In this study, the effectiveness and safety of the infliximab biosimilar CT-P13 in the treatment of inflammatory bowel disease (IBD) in real-life practice were analyzed. Our results show that CT-P13 is an effective and safe biosimilar of infliximab, and is a valid and attractive alternative for the treatment of IBD as it allows for a reduction of healthcare costs and facilitates access to biological treatments for more patients.