Background: Limited data are available on long-term clinical outcomes regarding the switch from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients.
Aims: To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity.
Methods: We performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients.
Results: Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up. Disease activity (Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index) as well as inflammatory markers (CRP, fecal calprotectin) did not change significantly during the 1-year follow-up. In total, 7 out of 83 patients (8%) demonstrated detectable antidrug antibodies during follow-up, and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching. Six patients (7%) discontinued CT-P13 due to adverse events.
Conclusions: Following a switch from Remicade® to CT-P13, 82% of IBD patients continued treatment through 1 year. Disease activity scores and inflammatory markers remained unchanged during follow-up, and no CT-P13-related serious adverse events occurred. These 1-year data suggest that switching to CT-P13 in Remicade®-treated IBD patients is safe and feasible.
Keywords: Biosimilar pharmaceuticals; Disease activity; Immunogenicity; Inflammatory bowel diseases; Infliximab; Switch.