Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study

Abstract

Background and aims: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients.

Methods: Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study. Primary endpoint was change in Harvey-Bradshaw Index for Crohn's disease [CD] and Simple Clinical Colitis Activity Index for ulcerative colitis [UC] at week 16. We measured C-reactive protein [CRP], faecal calprotectin [FCP], infliximab trough level [TL] and anti-drug antibodies [ADAs] and documented adverse events.

Results: Our cohort consisted of 83 patients (28 males, 57 CD, 24 UC, 2 IBD-unclassified [IBD-U]). The median age was 36 years, range 18-79. Median change in disease activity was 0 [range -23 to +7] for CD and 0 [range -3 to +6] for UC/IBD-U. Median CRP and FCP levels did not change significantly during follow-up. Median TL increased from 3.5 µg/ml [range 0-18] to 4.2 µg/ml [range 0-21] at week 16 [p = 0.010]. Two patients developed a new detectable ADA response during follow-up and five patients discontinued CT-P13. No serious adverse events occurred.

Conclusions: We demonstrated that switching from Remicade® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes. These results suggest that switching from Remicade® to CT-P13 for the treatment of IBD is feasible.

Keywords: Inflammatory bowel disease; biosimilar; switch.