Switching from reference infliximab to biosimilar CT-P13 did not change quality of life in stable inflammatory bowel disease patients

Author(s):
Pierik, M.J.; Meulen, A.E. van der (0000-0001-9353-5431); Linde, K. van der; Lutgens, M.; Kuijvenhoven, J.P.; Akol, H.; Klompmaker, I.J.; Sikkens, M.S.G.; Megen, Y.J.B. van; Stoop, C.M.; Bloemsaat-Minekus, J.P.J.; Dijkstra, G.
Published
2022
Publication type
Article / Letter to editor

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.

quality of lifeinfliximabbiosimilarinflammatory bowel disease
Date issued
2022-07-01
Language
English
Publisher
Oxford University Press
Is part of
Crohn's & Colitis 360 (2022), No. 3
hdl
1887/3769261
doi
10.1093/crocol/otab001
URL
https://academic.oup.com/crohnscolitis360/article/4/3/otab001/6134810