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
ARTICLE HIGHLIGHTS
Research background

Authorization of infliximab biosimilars has revolutionized the treatment of inflammatory bowel disease (IBD), in terms of both clinical practice and cost reduction. Although several studies have evaluated the safety and efficacy of infliximab biosimilar, some have retrospective designs and small study populations.

Research motivation

There is a need to evaluate the effectiveness and safety of these drugs in daily clinical practice in patients with IBD.

Research objectives

The objective of the present study was to evaluate the efficacy and safety of infliximab biosimilar in real-world practice.

Research methods

The authors performed a multicenter, observational, prospective study in Spanish hospitals based on the real-world clinical practice of the participating physicians.

Research results

After 12 mo of treatment, 64.2% (n = 52/81) of patients were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had achieved a clinical response or 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; of these, nine (26.5%) were serious.

Research conclusions

CT-P13 (Remsima®) is an effective and safe infliximab biosimilar for the treatment of Crohn's disease and ulcerative colitis in real-life practice. It is a valid and attractive alternative for the treatment of IBD, as it reduces healthcare costs and facilitates access to biological treatments for more patients.

Research perspectives

New studies will be necessary to provide more in-depth information on the management of IBD with infliximab biosimilar in clinical practice.