Retrospective Cohort Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2024; 30(46): 4904-4913
Published online Dec 14, 2024. doi: 10.3748/wjg.v30.i46.4904
Real-world experience and long-term outcomes of a mandatory non-medical switch of adalimumab originator to biosimilars in inflammatory bowel disease
Jeremy Liu Chen Kiow, Thomas Hoang, Harjot K Bedi, Zhina Majdzadeh Ardekani, Daniel Rosenfeld, Marica Reise-Filteau, Brian Bressler, Yvette Leung, Greg Rosenfeld
Jeremy Liu Chen Kiow, Department of Medicine, Division of Gastroenterology, Montreal University Hospital Centre (CHUM), Montreal H2X 3E4, Quebec, Canada
Jeremy Liu Chen Kiow, Harjot K Bedi, Marica Reise-Filteau, Brian Bressler, Yvette Leung, Greg Rosenfeld, Department of Gastroenterology, St. Paul’s Hospital, Vancouver V6Z 1Y6, British Columbia, Canada
Jeremy Liu Chen Kiow, Thomas Hoang, Harjot K Bedi, Zhina Majdzadeh Ardekani, Marica Reise-Filteau, Brian Bressler, Yvette Leung, Greg Rosenfeld, Department of Medicine, University of British Columbia, Vancouver V6T 1Z4, British Columbia, Canada
Jeremy Liu Chen Kiow, Marica Reise-Filteau, Brian Bressler, Yvette Leung, Greg Rosenfeld, Department of Gastroenterology, IBD Centre of BC, Vancouver V6Z 2L2, British Columbia, Canada
Daniel Rosenfeld, Department of Medicine, University of Western Ontario, London N6A 3K7, Ontario, Canada
Co-corresponding authors: Jeremy Liu Chen Kiow and Greg Rosenfeld.
Author contributions: Liu Chen Kiow J and Rosenfeld G contribute equally to this study as co-corresponding authors. Study concept and design were conducted by Liu Chen Kiow J, Hoang T, Bedi HK, and Rosenfeld G; acquisition of data was conducted by Liu Chen Kiow J, Hoang T, Majdzadeh Ardekani Z, Rosenfeld D; analysis, interpretation of data and statistical analysis were conducted by Liu Chen Kiow J and Hoang T; drafting of the manuscript was conducted by Liu Chen Kiow J, Hoang T, and Majdzadeh Ardekani Z; critical revision of the manuscript for important intellectual content and final approval were conducted by Liu Chen Kiow J, Hoang T, Bedi HK, Majdzadeh Ardekani Z, Rosenfeld D, Reise-Filteau M, Bressler B, Leung Y, Rosenfeld G.
Institutional review board statement: This study was approved by the University of British Columbia Providence Health Care Research Ethics Board.
Informed consent statement: Although a waiver of consent was granted, informed consent was obtained from most participants to include their data in our IBD database for research purposes.
Conflict-of-interest statement: Liu Chen Kiow J, Hoang T, Bedi HK, Majdzadeh Ardekani Z, Rosenfeld D, Reise-Filteau M have no relevant conflicts of interest to disclose. Bressler B has served on advisory boards and received speaker fees from Ferring, Janssen, Abbvie, Takeda, Pfizer, BMS, Merck, Sandoz, Organon, Lifelabs, Celltrion, Alimentiv, Gilead, Iterative Health, Celgene, Merck, Amgen, Pendopharm, Eli Lilly, Fresenius Kabi, Mylan, Viatris, Bausch Health, BioJamp Pharma, and Eupraxia. BB has received research support, though not directly for this project, from Janssen, Abbvie, GSK, BMS, Amgen, Genentech, and Merck. Bressler B has Qu Biologic stock options. Leung Y has served on advisory boards and received speaker fees from Janssen, Abbvie, Organon, Pfizer, Takeda, BMS, Amgen, Celltrion, and Eli Lilly. Rosenfeld G has received honoraria from Abbvie, Frensius-Kabi, Janssen, Pfizer, Takeda, Merck, Amgen, Viatris, Organon and Ferring as a speaker, adviser, and consultant. GR has research grant support, though not directly for this study, from Abbvie, Pfizer, Ferring and Crohn’s and Colitis Canada.
Data sharing statement: The data underlying this article are available in the article.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jeremy Liu Chen Kiow, MD, Department of Medicine, Division of Gastroenterology, Montreal University Hospital Centre (CHUM), 1051 Rue Sanguinet, Montreal H2X 3E4, Quebec, Canada. jeremy.liu.chen.kiow@umontreal.ca
Received: September 2, 2024
Revised: October 10, 2024
Accepted: November 4, 2024
Published online: December 14, 2024
Processing time: 79 Days and 8 Hours
Abstract
BACKGROUND

Over the last decade, the treatment options for inflammatory bowel disease (IBD) have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation. Adalimumab (ADA) is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD. In April 2021, the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira® to ADA biosimilars. Biosimilars offer a potential cost-effective, safe, and efficacious alternative to the originator, yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.

AIM

To assess the long-term outcomes of non-medical switching from the ADA originator Humira® to an ADA biosimilar among IBD patients.

METHODS

A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar. The primary outcome was treatment persistence at 30 months post-switch. Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation, loss of response (LOR) rates, adverse events (AE), and clinical and biochemical remission status. Patients who remained on the originator throughout the switch period, through compassionate support or private pay, constituted the comparison group.

RESULTS

Patients in the originator (n = 43) and biosimilar switch (n = 228) groups displayed similar demographics and baseline disease characteristics. By the study endpoint of 30 months, there was no difference in the rate of treatment persistence in either group (n = 36, 83.7% originator group vs n = 201, 88.2% biosimilar group, P = 0.451). Treatment persistence demonstrated similar rates of discontinuation between both study groups (log-rank P = 0.543). There was a numerical but not statistically significant difference in rates of adverse outcomes between either group (39.5% originator vs 28.9% biosimilars, P = 0.206). This included comparable rates of LOR (27.9% vs 17.5%) or AE (11.6% vs 11.4%) between the originator and biosimilar cohorts, respectively. C-reactive protein and fecal calprotectin levels were similar one year pre- and post-switch.

CONCLUSION

These data support the long-term efficacy and safety of non-medical ADA switching in IBD and will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching.

Keywords: Inflammatory bowel disease; Ulcerative colitis; Crohn’s disease; Biologics; Adalimumab; Biosimilar switch

Core Tip: Although there have been several studies evaluating the short-term clinical outcomes of adalimumab (ADA) biosimilar switching, there has been a lack of data assessing the long-term outcomes, especially in Canada. Non-medical switching of the ADA originator to biosimilars did not result in significant differences in treatment persistence, loss of response, or adverse events compared to ADA originator continuation in inflammatory bowel disease (IBD). The findings from this real-world evidence study support the long-term efficacy and safety of non-medical ADA switching in IBD. These data will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching and guide future biosimilar adoption and practice guidelines.