eISSN: 1897-4317
ISSN: 1895-5770
Gastroenterology Review/Przegląd Gastroenterologiczny
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abstract:
Original paper

Biosimilar infliximab versus originator in Crohn’s disease anti-TNF-α naïve and non-naïve patients

Magdalena Kaniewska
1
,
Mariusz Rosołowski
2
,
Andrzej Moniuszko
1
,
Grazyna Rydzewska
1, 3

1.
Department of Internal Medicine and Gastroenterology with Inflammatory Bowel Diseases Unit, Central Clinical Hospital of the Ministry of the Interior and Administration, Warsaw, Poland
2.
Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland
3.
Faculty of Medicine and Health Science, Jan Kochanowski University, Kielce, Poland
Gastroentereology Rev
Online publish date: 2020/11/12
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Introduction
Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve 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-α naïve and non-naïve 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 one 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-α naïve. There were no differences in clinical remission rate between naïve and non-naïve 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-α non-naïve patients (p < 0.001) with no significant differences between two groups. Adverse events were more common in anti-TNF-α non-naïve patients with no difference between infliximab and biosimilar groups (13.3% vs. 17.6%, respectively). The infliximab group of anti-TNF-α naïve 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-α naïve and non-naïve patients with Crohn’s disease. Relapse rate during follow-up was significantly higher in anti-TNF-α non-naïve patients, but with no significant differences between originator and biosimilar.

keywords:

inflammatory bowel disease, Crohn’s disease, biological treatment, biosimilar, anti-TNF-α naïve, infliximab

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