Lay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study... Show moreLay Summary Patients with inflammatory bowel disease were switched from the originator infliximab to the biosimilar CT-P13. Before and after switching they filled in questionnaires. The study showed that switching did not reduce the quality of life and efficacy of the treatment.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. Show less
Pierik, M.J.; Meulen, A.E. van der; Linde, K. van der; Lutgens, M.; Kuijvenhoven, J.P.; Akol, H.; ... ; Dijkstra, G. 2022
BackgroundQuality 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... Show moreBackgroundQuality 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.MethodsOoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions.ResultsOne 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.ConclusionsSwitching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated. Show less
