Effectiveness and safety of the switch from Remicade to CT-P13 in patients with inflammatory bowel disease.
J Crohns Colitis. 2019 Apr 12;:
Authors: Chaparro M, Garre A, Guerra Veloz MF, Vázquez JM, De Castro ML, Leo E, Rodriguez E, Carbajo AY, Riestra S, Jiménez I, Calvet X, Bujanda L, Rivero M, Gomollón F, Benítez JM, Bermejo F, Alcaide N, Gutiérrez A, Mañosa M, Iborra M, Lorente R, Rojas-Feria M, Barreiro-de Acosta M, Kolle L, Van Domselaar M, Amo V, Argüelles F, Ramírez E, Morell A, Bernardo D, Gisbert JP
AIMS: To evaluate the clinical outcomes in patients with IBD after switching from Remicade to CT-P13 in comparison with patients who maintain Remicade .
METHODS: Patients under Remicade who were in clinical remission with standard dosage at study entry were included. The switch cohort (SC) comprised patients who made the switch from Remicade to CT-P13, and the “non-switch” cohort (NC) patients kept under Remicade .
RESULTS: Four hundred seventy-six patients were included: 199 (42%) in the SC and 277 (58%) in the NC. Median follow-up was 18 months in the SC and 23 months in the NC (p<0.01). Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR=3.5, 95%CI=2-6). Thirteen percent of patients had adverse events in the NC and 6% in the SC (p<0.05).
CONCLUSIONS: Switching from Remicade to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. Nocebo effect might have influenced this result. Switching from Remicade to CT-P13 was safe.
PMID: 30976785 [PubMed – as supplied by publisher]