Infliximab discontinuation in patients with originator retransition vs biosimilar continuation

Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(3):107
DOI: 10.5639/gabij.2023.1203.017

Published in: Volume 12 / Year 2023 / Issue 3
Category: Research News
Page: 107
Visits: 391 total, 7 today

Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023

A study by Meijboom et al. aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar [1].

When the market exclusivity of the originator infliximab (Remicade) expired in 2014, many patients with inflammatory bowel disease (IBD) transitioned from the originator infliximab to an infliximab biosimilar, driven by cost containment reasons. Transitioning has been proven safe and effective in several double-blind studies, with numerous patients successfully making the switch in clinical practice.

However, approximately 7% of these patients subsequently retransitioned to the originator infliximab (i.e. they stopped the biosimilar and reinitiated the originator), mainly due to a (perceived) increase in disease activity or adverse events after transitioning to the biosimilar. It is unclear whether this sign of potential unsatisfactory treatment response is specifically related to the infliximab biosimilar, the patient, and/or the disease, including patients’ beliefs about the biosimilar.

Therefore, Meijboom et al. conducted a study with the aim of comparing the risk and reasons for infliximab discontinuation between two groups of patients: those who retransitioned to the originator and those who remained on biosimilar. The study included patients with IBD who had initially transitioned from infliximab originator to the corresponding biosimilar.

The risk and reason for retransitioning were assessed in all IBD patients who transitioned from infliximab originator to biosimilar between January 2015 and September 2019 in two Dutch hospitals. Retransitioned patients were matched with patients remaining on biosimilar (biosimilar remainder patients). The authors categorized patients’ reasons for discontinuing as either an unwanted response (i.e. loss of effect and/or adverse events) or as disease remission. A comparison of the risk of discontinuation due to an unwanted response was conducted between the two cohorts using a Cox proportional hazards model.

The study findings revealed that 22.7% of patients in the retransitioning cohort vs 13.4% in the biosimilar remainder cohort discontinued infliximab due to an unwanted response, and 2.3% vs 9.4% of patients, respectively, discontinued because their disease was in remission. The authors noted that retransitioned patients had more than threefold increased risk of discontinuing due to an unwanted response compared with biosimilar remainder patients (adjusted HR 3.7, 95% CI: 1.0–13.9).

Meijboom et al. further zoomed in on the retransitioned patients. About one in six retransitioned patients retransitioned due to objectively measured increased disease activity, e.g. elevated calprotectin and/or active disease seen on endoscopy, the other patients due to (subjective) symptoms only. Patients who retransitioned due to objectively increased disease activity discontinued their infliximab treatment more often than patients who retransitioned due to symptoms only (66.7% versus 23.7%).

In conclusion, the study demonstrated that patients who retransitioned were more likely to discontinue infliximab treatment due to an unwanted response compared to patients who remained on biosimilar. On the other hand, patients who remained on the biosimilar were more likely to discontinue infliximab due to remission. Patients who retransitioned had more than a threefold increased risk of discontinuing infliximab due to an unwanted response compared to patients who remained on the biosimilar. These findings indicate that retransitioning is mainly related to the patient and/or their disease, including the patients’ beliefs about the biosimilar. It is less likely to be related to the infliximab biosimilar itself.

The reason for retransitioning, which might have an impact on the course of infliximab originator treatment, is objectively measured disease activity or symptoms only, and it could be of importance in clinical decision-making. Clinicians could consider patients who opt for retransitioning to another treatment option.

Competing interests: The authors of the research paper [1] declared that there were no conflicts of interest.

Provenance and peer review: Commissioned; internally peer reviewed.

Reference
1. Meijboom RW, Gardarsdottir H, Becker ML, Movig KLL, Kuijvenhoven J, Egberts TCG, et al. 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.

Author: Rosanne Meijboom, Trainee Researcher, Pharmacy Foundation of Haarlem Hospitals (SAHZ), Boerhaavelaan 24, 2035 RC, Haarlem, The Netherlands

Disclosure of Conflict of Interest Statement is available upon request.

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