Biosimilar infliximab versus originator in Crohn's disease anti-TNF-alpha naive and non-naive patients

Introduction: Data comparing response to originator and biosimilar infliximab in anti-TNF-alpha naive and non-naive Crohn's disease patients is limited. Aim: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-alpha naive and non-naive Crohn's disease patients. Data comparing response in those two groups of patients are limited. Material and methods: This retrospective single-centre study enrolled 168 adult Crohn's disease patients treated for 1 year with infliximab originator or biosimilar. Assessment included achievement of clinical remission (during induction and maintenance therapy and follow-up period - 24 months) and occurrence of adverse events. Results: Forty-seven patients taking infliximab and 68 on biosimilar were anti-TNF-alpha naive. There were no differences in clinical remission rate between naive and non-naive patients after 1 year of treatment (infliximab - 80.9% and 73.1%, respectively; biosimilar - 79.4% and 74.1%, respectively). The relapse rate during the follow-up period was higher in anti-TNF-alpha non-naive patients (p < 0.001) with no significant differences between two groups. Adverse events were more common in anti-TNF-alpha nonnaive patients with no difference between infliximab and biosimilar groups (13.3% vs. 17.6%, respectively). The infliximab group of anti-TNF-alpha naive patients had a higher rate of adverse events compared to the biosimilar (8.1% vs. 1.9%), but it did not reach statistical significance. Conclusions: This is a study comparing anti-TNF-alpha naive and non-naive patients with Crohn's disease. Relapse rate during follow-up was significantly higher in anti-TNF-alpha non-naive patients, but with no significant differences between originator and biosimilar.