BackgroundLimited 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.AimsTo investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity.MethodsWe performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients.ResultsEighty-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.ConclusionsFollowing 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.
Endoscopic screening in HDGC families without a pathogenic CDH1 mutation may be reasonable, as we detected signet ring cell carcinomas in 6% of persons screened. However, the criteria and frequency of screening may have to be reconsidered.
Background:The infliximab biosimilar CT-P13 is EMA and FDA approved, based on data extrapolated from phase III studies in rheumatoid arthritis and ankylosing spondylitis patients. Anti-tumor necrosis factor (TNF) naive IBD patients frequently start CT-P13 in current daily practice but the switch from Remicade ® to CT-P13 is less
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