Long-Term Clinical Outcomes After Switching from Remicade^sup ®^ to Biosimilar CT-P13 in Inflammatory Bowel Disease

• Published in: Digestive diseases and sciences 2017-11, Vol.62 (11), p.3117
• Main Authors: Smits, Lisa J, T, Grelack, Anna, Derikx, Lauranne A, A, P, de Jong, Dirk J, van Esch, Aura A, J, Boshuizen, Ronald S, Drenth, Joost P, H, Hoentjen, Frank
• Format: Article
• Language: English
• Subjects: Clinical outcomes; Colon; Crohn's disease; Immunotherapy; Inflammatory bowel disease; Monoclonal antibodies; TNF inhibitors
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-017-4661-4

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. To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity. We performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients. 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. 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.