Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar

People with Crohn disease (CD) or ulcerative colitis (UC) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.

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A large, French observational study (ReFLECT) investigated treatment persistence with the infliximab biosimilar CT-P13 (Inflectra) in patients with inflammatory bowel disease (IBD) who were either infliximab-naive or were switching from the reference product (Remicade) or biosimilar SB2. Overall, treatment persistence was 72% in patients with Crohn disease and 64% in ulcerative colitis at 2 years, and the rate of persistence was higher in switched patients compared to infliximab-naive patients. No new safety signals were observed.

CT-P13 was the first biosimilar monoclonal antibody approved by the European Medicines Agency in 2013, and the first biosimilar to Remicade, an inhibitor of tumor necrosis factor (TNF)- α. Its approval in Europe and extrapolation to all the indications of the reference product were based on randomized controlled trials in patients with rheumatoid arthritis and ankylosing spondylitis. More recently, large randomized controlled trials have established efficacy and safety of switching to CT-P13 from the originator in IBD. Although the safety and efficacy of CT-P13 has been demonstrated by these randomized controlled trials, the authors said, few real-world studies have reported CT-P13 persistence in IBD with follow-up duration longer than 1 year.

The ReFLECT study was a prospective, observational cohort study conducted across multiple centers in France to evaluate real-world effectiveness and safety of intravenous CT-P13. The adult population with IBD included 530 patients with CD (71%), including 327 with no prior infliximab exposure, and 221 patients with UC (29%), including 152 who were infliximab-naive. The primary outcome of the study was persistence on CT-P13 after a 2-year follow-up period. Secondary outcomes included biochemical parameters, disease activity, and safety.

In patients with CD, the estimated persistence rate was 81.5% (95% CI, 76.7-86.6) at 1 year and 71.7% (95% CI, 66.7-77.0) at 2 years. Treatment persistence was higher in switched patients (83.7%; 95 % CI, 78.0-89.9) compared to infliximab-naive patients (65.7%; 95% CI, 58.6-73.7) with CD. In UC, the estimated CT-P13 persistence rate was 73.4 % (95% CI, 64.8-83.0) after 1 year and 63.7 % (95% CI, 55.3-73.3) after 2 years. Treatment persistence was also higher in switched patients with UC (91.2%; 95% CI, 81.7-100.0) compared to infliximab-naive patients with UC (53.4%; 95% CI, 43.0-66.2). The most common reasons for discontinuing CT-P13 treatment were treatment failure and intolerance in CD, and treatment failure, intolerance, and remission in UC.

Disease activity, indicated by Harvey Bradshaw Index, in CD, decreased over the follow-up period for infliximab-naive patients and remained stable for switched patients. In UC, Mayo score decreased over time in infliximab-naive patients, and decreased following the first CT-P13 administration, then remained stable in switched patients. In both CD and UC, C-reactive protein decreased over the follow-up period in infliximab-naive patients and remained stable in switched patients.

About half of patients (49.5%) reported at least 1 adverse event (AE). Serious AEs occurred in 13% of patients, and AEs with a possible relationship to CT-P13 treatment occurred in 18% of patients. Adverse events were “consistent with those from other prospective observational studies of CT-P13 in patients with IBD,” the authors wrote.

The authors said that their findings, consistent with previous observational studies, demonstrated maintained effectiveness of CT-P13 in more than 80% of switched patients over 2 years and “improved disease activity with sustained clinical benefit” in infliximab-naive patients.

Reference

Laharie D, Bouhnik Y, Vuitton L, et al. Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study). Clin Res Hepatol Gastroenterol. 2024;48(10):102483. doi:10.1016/j.clinre.2024.102483