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Oxford University Press, Crohn's & Colitis 360, 3(4), 2021

DOI: 10.1093/crocol/otab001

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Switching from Reference Infliximab to Biosimilar CT-P13 did not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

Journal article published in 2021 by Marieke J. Pierik, Andrea E. van der Meulen ORCID, Klaas Van der Linde, Maurice Lutgens, Johan P. Kuijvenhoven ORCID, Halil Akol, Ids J. Klompmaker, Michelle S. G. Sikkens, Yvonne J. B. van Megen, Corinne M. Stoop, Joanne P. J. Bloemsaat-Minekus ORCID, Gerard Dijkstra
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Abstract

Abstract Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. Results One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference −0.02 (95% confidence interval −0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. Conclusions Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.