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.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802295 | PMC |
| http://dx.doi.org/10.1093/crocol/otab001 | DOI Listing |
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