Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar

Rosanne W Meijboom; Helga Gardarsdottir; Matthijs L Becker; Kris L L Movig; Johan Kuijvenhoven; Toine C G Egberts; Thijs J Giezen

doi:10.1177/17562848231197923

Discontinuation of infliximab treatment in patients with inflammatory bowel disease who retransitioned to originator and those who remained on biosimilar

Therap Adv Gastroenterol. 2023 Sep 11:16:17562848231197923. doi: 10.1177/17562848231197923. eCollection 2023.

Authors

Rosanne W Meijboom^{1

2}, Helga Gardarsdottir^{2

3

4}, Matthijs L Becker^{1

5}, Kris L L Movig⁶, Johan Kuijvenhoven⁷, Toine C G Egberts^{2

3}, Thijs J Giezen^{8

2

5}

Affiliations

¹ Pharmacy Foundation of Haarlem Hospitals, Haarlem, the Netherlands.
² Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
³ Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands.
⁴ Department of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland.
⁵ Department of Clinical Pharmacy, Spaarne Gasthuis, Haarlem, the Netherlands.
⁶ Department of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, the Netherlands.
⁷ Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Haarlem, the Netherlands.
⁸ Pharmacy Foundation of Haarlem Hospitals, Boerhaavelaan 24, Haarlem 2035 RC, the Netherlands.

Abstract

Background: Many patients with inflammatory bowel disease (IBD) have transitioned from an infliximab originator to a biosimilar. However, some patients retransition to the originator (i.e. stop biosimilar and reinitiate the originator). Whether this sign of potential unsatisfactory treatment response is specifically related to the infliximab biosimilar or the patient and/or the disease including patients' beliefs on the biosimilar is unclear.

Objectives: We aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar.

Design: Non-interventional, multicentre cohort study.

Methods: IBD patients who transitioned from infliximab originator to biosimilar between January 2015 and September 2019 in two Dutch hospitals were eligible for this study. Retransitioned patients (retransitioning cohort) were matched with patients remaining on biosimilar (biosimilar remainder cohort). Reasons for discontinuation were categorised as the unwanted response (i.e. loss of effect or adverse events) or remission. Risk of unwanted discontinuation was compared using Cox proportional hazards models.

Results: Patients in the retransitioning cohort (n = 44) were younger (median age 39.9 versus 44.0 years), more often female (65.9% versus 48.9%) and had shorter dosing intervals (median 48.5 versus 56.0 days) than in the biosimilar remainder cohort (n = 127). Infliximab discontinuation due to unwanted response was 22.7% in the retransitioning and 13.4% in the biosimilar remainder cohort, and due to remission was 2.3% and 9.4%, respectively. Retransitioned patients are at increased risk of discontinuing due to unwanted response compared with biosimilar remainder patients (adjusted HR 3.7, 95% CI: 1.0-13.9). Patients who retransitioned due to an increase in objective disease markers had higher discontinuation rates than patients who retransitioned due to symptoms only (66.7% versus 23.7%).

Conclusion: Retransitioned patients are at increased risk of infliximab discontinuation due to unwanted response. Retransitioning appeared related to the patient and/or disease and not the product. Clinicians might switch patients opting for retransitioning to other treatment regimens.

Keywords: biosimilar; inflammatory bowel disease; infliximab.