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Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease

2019; Oxford University Press; Volume: 13; Issue: 11 Linguagem: Inglês

10.1093/ecco-jcc/jjz070

1876-4479

María Chaparro, Ana Garre, María Fernanda Guerra Veloz, Juan María Vázquez Morón, M L De Castro, E Leo, Esther Rodríguez, A Y Carbajo, Sabino Riestra, I Jiménez, Xavier Calvet, Luís Bujanda, Montserrat Rivero, Fernando Gomollón, J M Benítez, Fernando Bermejo, Noelia Alcaide, Ana Gutiérrez, Míriam Mañosa, Marisa Iborra, R Lorente, M Rojas-Feria, Manuel Barreiro‐de Acosta, Lilyan Kolle, Manuel Van Domselaar, V Amo, Federico Argüelles‐Arias, Esmitt Ramírez, Alberto Morell, David Bernardo, Javier P. Gisbert,

Health Systems, Economic Evaluations, Quality of Life

To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®.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 remained under Remicade®.A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The 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% confidence interval [CI] = 2-6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05].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. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.