Effectiveness and Safety of the Switch from Remicade (R) to CT-P13 in Patients with Inflammatory Bowel Disease
Por:
Chaparro, M, Garre, A, Veloz, M, Moron, J, De Castro, M, Leo, E, Rodriguez, E, Carbajo, A, Riestra, S, Jimenez, I, Calvet, X, Bujanda, L, Rivero, M, Gomollon, F, Benitez, J, Bermejo, F, Alcaide, N, Gutierrez A, Manosa, M, Iborra, M, Lorente, R, Rojas-Feria, M, Barreiro-de Acosta, M, Kolle, L, Van Domselaar, M, Amo, V, Arguelles, F, Ramirez, E, Morell, A, Bernardo, D and Gisbert, J
Publicada:
1 nov 2019
Resumen:
Background and Aims: To evaluate the clinical outcomes in patients with IBD after switching from Remicade (R) to CT-P13 in comparison with patients who maintain Remicade (R).
Methods: Patients under Remicade (R) 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 (R) to CT-P13, and the 'non-switch' cohort [NC] patients remained under Remicade (R).
Results: 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].
Conclusions: Switching from Remicade (R) 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 (R) to CT-P13 was safe.
Filiaciones:
Chaparro, M:
Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Gastroenterol Unit, Madrid, Spain
CIBEREHD, Gastroenterol Unit, Madrid, Spain
Garre, A:
Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Gastroenterol Unit, Madrid, Spain
CIBEREHD, Gastroenterol Unit, Madrid, Spain
Veloz, M:
Hosp Univ Virgen Macarena, Gastroenterol Unit, Seville, Spain
Moron, J:
Hosp Juan Ramon Jimenez, Gastroenterol Unit, Huelva, Spain
De Castro, M:
Complejo Hosp Univ Vigo, Gastroenterol Unit, Vigo, Spain
Leo, E:
Hosp Univ Virgen del Rocio, Gastroenterol Unit, Seville, Spain
Rodriguez, E:
Hosp Univ Nuestra Senora de Candelaria, Gastroenterol Unit, Santa Cruz De Tenerife, Spain
Carbajo, A:
Hosp Univ Rio Hortega, Gastroenterol Unit, Valladolid, Spain
Riestra, S:
Hosp Univ Cent Asturias, Gastroenterol Unit, Asturias, Spain
ISPA, Gastroenterol Unit, Asturias, Spain
Jimenez, I:
Hosp Galdakao Usansolo, Gastroenterol Unit, Vizcaya, Spain
Calvet, X:
Consorci Corp Sanitaria Parc Tauli Sabadell, Gastroenterol Unit, Barcelona, Spain
CIBERehd, Gastroenterol Unit, Barcelona, Spain
Bujanda, L:
Univ Pais Vasco UPV EHU, Gastroenterol Unit, Inst Biodonostia, San Sebastian, Spain
CIBEREHD, Gastroenterol Unit, San Sebastian, Spain
Rivero, M:
Hosp Univ Marques de Valdecilla, Gastroenterol Unit, Santander, Spain
IDIVAL, Gastroenterol Unit, Santander, Spain
Gomollon, F:
Hosp Clin Univ Lozano Blesa, Gastroenterol Unit, IIS Aragon, Zaragoza, Spain
CIBEREHD, Gastroenterol Unit, Zaragoza, Spain
Benitez, J:
Hosp Univ Reina Sofia, Gastroenterol Unit, Cordoba, Spain
Bermejo, F:
Hosp Univ Fuenlabrada, Gastroenterol Unit, Madrid, Spain
Hosp Univ La Paz IdiPAZ, Gastroenterol Unit, Inst Invest Sanitaria, Madrid, Spain
Alcaide, N:
Hosp Clin Univ Valladolid, Gastroenterol Unit, Valladolid, Spain
Gutierrez A:
Hosp Gen Univ Alicante, Gastroenterol Unit, Alicante, Spain
CIBEREHD, Gastroenterol Unit, Alicante, Spain
Manosa, M:
CIBERehd, Gastroenterol Unit, Barcelona, Spain
Hosp Germans Trials & Pujol, Gastroenterol Unit, Barcelona, Spain
Iborra, M:
Hosp Univ & Politecn La Fe, Gastroenterol Unit, Valencia, Spain
CIBEREHD, Gastroenterol Unit, Valencia, Spain
Lorente, R:
Hosp Gen Univ Ciudad Real, Gastroenterol Unit, Ciudad Real, Spain
Rojas-Feria, M:
Hosp Univ Nuestra Senora Valme, Gastroenterol Unit, Seville, Spain
Barreiro-de Acosta, M:
Hosp Clin Univ Santiago, Gastroenterol Unit, Santiago De Compostela, Spain
Kolle, L:
Hosp Gen La Palma, Gastroenterol Unit, La Palma, Spain
Van Domselaar, M:
Hosp Univ Torrejon, Gastroenterol Unit, Madrid, Spain
Amo, V:
Hosp Reg Univ Malaga, Gastroenterol Unit, Malaga, Spain
Arguelles, F:
Hosp Univ Virgen Macarena, Gastroenterol Unit, Seville, Spain
Ramirez, E:
Hosp Univ La Princesa, Gastroenterol Unit, IIS IP, Pharm Unit, Madrid, Spain
Morell, A:
Hosp Univ La Princesa, Gastroenterol Unit, IIS IP, Pharm Unit, Madrid, Spain
Bernardo, D:
Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Gastroenterol Unit, Madrid, Spain
CIBEREHD, Gastroenterol Unit, Madrid, Spain
Gisbert, J:
Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Gastroenterol Unit, Madrid, Spain
CIBEREHD, Gastroenterol Unit, Madrid, Spain
Open Access
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