Published online Dec 26, 2021. doi: 10.12998/wjcc.v9.i36.11285
Peer-review started: April 22, 2021
First decision: May 24, 2021
Revised: June 4, 2021
Accepted: July 2, 2021
Article in press: July 2, 2021
Published online: December 26, 2021
Processing time: 244 Days and 17.3 Hours
Authorization of infliximab biosimilars has revolutionized the treatment of inflammatory bowel disease (IBD), in terms of both clinical practice and cost reduction. Although several studies have evaluated the safety and efficacy of infliximab biosimilar, some have retrospective designs and small study populations.
There is a need to evaluate the effectiveness and safety of these drugs in daily clinical practice in patients with IBD.
The objective of the present study was to evaluate the efficacy and safety of infliximab biosimilar in real-world practice.
The authors performed a multicenter, observational, prospective study in Spanish hospitals based on the real-world clinical practice of the participating physicians.
After 12 mo of treatment, 64.2% (n = 52/81) of patients were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had achieved a clinical response or clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients; of these, nine (26.5%) were serious.
CT-P13 (Remsima®) is an effective and safe infliximab biosimilar for the treatment of Crohn's disease and ulcerative colitis in real-life practice. It is a valid and attractive alternative for the treatment of IBD, as it reduces healthcare costs and facilitates access to biological treatments for more patients.
New studies will be necessary to provide more in-depth information on the man