Journal of Gastrointestinal & Digestive System
Open Access

Abstract

Background: The evidence on efficacy and safety of biosimilars infliximab (IFX) in patients with inflammatory bowel diseases (IBD) is sparse. Methods: One cohort composed of prospectively followed patients who were switched from original to biosimilars IFX. The second cohort included retrospectively assessed anti-TNF���± na���¯ve patients who started therapy. Disease activity was assessed using standard clinical indices, endoscopic evaluation, and laboratory parameters. Trough levels (TL) and anti-drug antibodies (ATI) were also measured. Patients were evaluated 56 weeks (W56) after switch and at weeks 14 (W14) and 46 (W46) in the na���¯ve cohort. Results: 74 IBD patients were switched to biosimilars IFX and 119 na���¯ve patients newly initiated therapy with the preparation. Disease activity remained stable in majority of switched patients (remission at W0 vs. W56: 72.2% vs. 77.8%; median difference of both HBI and SCCAI between W0 and W56 was 0). Comparing W0 and W56, no significant difference in CRP and FC was observed. In total, 92% of CD and 83% of UC patients responded to induction therapy (W14) with biosimilars IFX. At W46 the response rate was 86% in CD and 64% in UC. Moreover, half of UC patients experienced mucosal healing at W14 and improvement of perianal disease occurred in 95% of CD at W46. No increase in immunogenicity was found in switched patients and type and frequency of adverse events were comparable to original preparation. Conclusion: Infliximab CT-P13 is affordable therapy in IBD patients.

Biography

Milan Lukas is a Professor in ISCARE Lighthouse Clinical Center IBD Clinical and Research Centre ISCARE and 1st Medical Faculty in Charles University, Czech Republic.