M Chaparro1, A Garre1, M F Guerra Veloz2, J M Vázquez Morón3, M L De Castro4, E Leo5, E Rodriguez6, A Y Carbajo7, S Riestra8, I Jiménez9, X Calvet10, L Bujanda11, M Rivero12, F Gomollón13, J M Benítez14, F Bermejo15, N Alcaide16, A Gutiérrez17, M Mañosa18, M Iborra19, R Lorente20, M Rojas-Feria21, M Barreiro-de Acosta22, L Kolle23, M Van Domselaar24, V Amo25, F Argüelles2, E Ramírez26, A Morell26, D Bernardo1, J P Gisbert1. 1. Gastroenterology Units from Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP] and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBERehd], Madrid, Spain. 2. Gastroenterology Units from Hospital Universitario Virgen Macarena, Sevilla, Spain. 3. Gastroenterology Units from Hospital Juan Ramón Jiménez, Huelva, Spain. 4. Gastroenterology Units from Complejo Hospitalario Universitario de Vigo, Vigo, Spain. 5. Gastroenterology Units from Hospital Universitario Virgen del Rocío, Sevilla, Spain. 6. Gastroenterology Units from Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain. 7. Gastroenterology Units from Hospital Universitario Río Hortega, Valladolid, Spain. 8. Gastroenterology Units from Hospital Universitario Central de Asturias and ISPA, Asturias, Spain. 9. Gastroenterology Units from Hospital de Galdakao-Usansolo, Vizcaya, Spain. 10. Gastroenterology Units from Consorcí Corporació Sanitària Parc Tauli de Sabadell and CIBERehd, Barcelona, Spain. 11. Gastroenterology Units from Instituto Biodonostia, Universidad del País Vasco [UPV/EHU] and CIBERehd, San Sebastián, Spain. 12. Gastroenterology Units from Hospital Universitario Marqués de Valdecilla and IDIVAL, Santander, Spain. 13. Gastroenterology Units from Hospital Clínico Universitario Lozano Blesa, IIS Aragón and CIBERehd, Zaragoza, Spain. 14. Gastroenterology Units from Hospital Universitario Reina Sofía, Córdoba, Spain. 15. Gastroenterology Units from Hospital Universitario de Fuenlabrada and Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain. 16. Gastroenterology Units from Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 17. Gastroenterology Units from Hospital General Universitario de Alicante and CIBERehd, Alicante, Spain. 18. Gastroenterology Units from Hospital Germans Trials i Pujol and CIBERehd, Barcelona, Spain. 19. Gastroenterology Units from Hospital Universitario y Politécnico de La Fe and CIBERehd, Valencia, Spain. 20. Gastroenterology Units from Hospital General Universitario de Ciudad Real, Ciudad Real, Spain. 21. Gastroenterology Units from Hospital Universitario Nuestra Señora de Valme, Sevilla, Spain. 22. Gastroenterology Units from Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain. 23. Gastroenterology Units from Hospital General de La Palma, La Palma, Spain. 24. Gastroenterology Units from Hospital Universitario de Torrejón, Madrid, Spain. 25. Gastroenterology Units from Hospital Regional Universitario de Málaga, Málaga, Spain. 26. Gastroenterology Units from Pharmacy Unit, Hospital Universitario de La Princesa, IIS-IP, Madrid, Spain.
Abstract
BACKGROUND AND 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 remained under Remicade®. 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® 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.
BACKGROUND AND 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 remained under Remicade®. 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® 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.
Authors: Jurij Hanzel; Jeroen M Jansen; Rinze W F Ter Steege; Krisztina B Gecse; Geert R D'Haens Journal: Inflamm Bowel Dis Date: 2022-03-30 Impact factor: 5.325