Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

Marieke J Pierik; Andrea E van der Meulen; Klaas Van der Linde; Maurice Lutgens; Johan P Kuijvenhoven; Halil Akol; Ids J Klompmaker; Michelle S G Sikkens; Yvonne J B van Megen; Corinne M Stoop; Joanne P J Bloemsaat-Minekus; Gerard Dijkstra

doi:10.1093/crocol/otab001

Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

Crohns Colitis 360. 2021 Feb 14;4(3):otab001. doi: 10.1093/crocol/otab001. eCollection 2022 Jul.

Affiliations

¹ Division of Gastroenterology and Hepatology, MUMC, Maastricht, The Netherlands.
² Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.
³ Department of Gastroenterology and Hepatology, MCL, Leeuwarden, The Netherlands.
⁴ Department of Gastroenterology and Hepatology, Elisabeth Tweesteden Ziekenhuis, Tilburg, The Netherlands.
⁵ Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Haarlem, The Netherlands.
⁶ Department of Gastroenterology and Hepatology, MC De Veluwe, Apeldoorn, The Netherlands.
⁷ Department of Gastroenterology and Hepatology, Wilhelmina Ziekenhuis Assen, Assen, The Netherlands.
⁸ Department of Gastroenterology-Hepatology, Dijklander Ziekenhuis, Enkhuizen, The Netherlands.
⁹ Medical Department, Mundipharma Pharmaceuticals B.V., Leusden, The Netherlands.
¹⁰ Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

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.

Keywords: biosimilar; inflammatory bowel disease; infliximab; quality of life.