Margalida Calafat1,2, Míriam Mañosa1,2, Elena Ricart2,3, Pilar Nos2,4, Eva Iglesias-Flores5, Isabel Vera6, Antonio López-Sanromán7, Jordi Guardiola8, Carlos Taxonera9, Miguel Mínguez10, M Dolores Martín-Arranz11, Luisa de Castro12, Ruth de Francisco13, Montserrat Rivero14, Esther Garcia-Planella15, Xavier Calvet2,16, Santiago García-López17, Lucía Márquez18, Fernando Gomollón2,19, Jesús Barrio20, Maria Esteve2,21, Fernándo Muñoz22, Javier P Gisbert2,23, Ana Gutiérrez2,24, Joaquín Hinojosa25, Federico Argüelles-Arias26, David Busquets27, Luís Bujanda2,28, José L Pérez-Calle29, Beatriz Sicilia30, Olga Merino31, Pilar Martínez32, Fernando Bermejo33, Rufo Lorente34, Manuel Barreiro-de Acosta35, Cristina Rodríguez36, Mariana Fe García-Sepulcre37, David Monfort38, Fiorella Cañete1,2, Eugeni Domènech1,2. 1. H.U. Germans Trias i Pujol, Badalona, Spain. 2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain. 3. H. Clínic Barcelona, Barcelona; IDIBAPS, Barcelona, Spain. 4. H. Universitari La Fe, València, Spain. 5. H. Reina Sofía, Córdoba, Spain. 6. H.U. Puerta de Hierro Majadahonda, Madrid, Spain. 7. H.U. Ramón y Cajal, Madrid, Spain. 8. H.U. Bellvitge (L'Hospitalet de Llobregat), Spain. 9. H.U. Clínico San Carlos, Madrid; Instituto de investigación del Hospital Clínico San Carlos, Madrid, Spain. 10. H.U. Clínico de València, València; Universitat de València, València, Spain. 11. H.U. La Paz, Madrid, Spain. 12. Complexo H.U, de Vigo, Vigo, Spain. 13. H.U. Central de Asturias and Instituto de Investigación Biosanitaria del principado de Asturias (ISPA), Oviedo, Spain. 14. H.U. Marqués de Valdecilla, Santander; IDIVAL, Santander, Spain. 15. H.U. de la Santa Creu i Sant Pau , Barcelona, Spain. 16. H.U. Parc Taulí , Sabadell, Spain. 17. H.U. Miguel Servet , Zaragoza, Spain. 18. Servei de Digestiu, Hospital del Mar, Barcelona and IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. 19. H. Clínico Lozano Blesa, Zaragoza; Instituto de Investigaciones Sanitarias de Aragón. 20. Servicio de Gastroenterología. Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain. 21. H. Universitari Mútua Terrassa, Terrassa, Spain. 22. H.U.Salamanca , Salamanca, Spain. 23. H. U. de la Princesa, Madrid; Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM). 24. H.G.U.Alicante, Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL) , Spain. 25. Hospital Vithas 9 de Octubre, València, Spain. 26. Servicio de Digestivo, Hospital Universitario Virgen Macarena, Sevilla; Profesor Facultad Medicina de la Universidad de Sevilla, Sevilla, Spain. 27. H. U. Girona Dr. J. Trueta, Girona, Spain. 28. Instituto Biodonostia, Universidad del País Vasco (UPV/EHU), San Sebastián, Spain. 29. H.U. Fundación de Alcorcón, Alcorcón, Spain. 30. Hospital Universitario de Burgos, Burgos, Spain. 31. H. de Cruces, Barakaldo, Spain. 32. H. 12 de Octubre, Madrid, Spain. 33. Hospital Universitario de Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz (IdiPAZ), Madrid, Spain. 34. H.General de Ciudad Real, Ciudad Real, Spain. 35. C.H.U. Clínico Santiago, Santiago de Compostela, Spain. 36. C.H. de Navarra, Pamplona, Spain. 37. H.G. Elche, Elche, Spain. 38. Consorci Sanitari de Terrassa, Terrassa, Spain.
Abstract
BACKGROUND AND AIMS: Immunomediated adverse events [IAEs] are the most frequently reported infliximab [IFX]-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. We aimed to compare the rates of IFX-related IAEs and loss of response [LOR] in elderly and younger patients. METHODS: Adult patients in the ENEIDA registry who had received a first course of IFX therapy were identified and grouped into two cohorts regarding age at the beginning of treatment [over 60 years and between 18 and 50 years]. The rates of IAEs and LOR were compared. RESULTS: In total, 939 patients [12%] who started IFX over 60 years of age and 6844 [88%] below 50 years of age were included. Elderly patients presented a higher proportion of AEs related to IFX [23.2% vs 19%; p = 0.002], infections [7.1% vs 4.3%; p < 0.001] and neoplasms [2.2% vs 0.5%; p < 0.001]. In contrast, the rates of IAEs [14.8% vs 14.8%; p = 0.999], infusion reactions [8.1% vs 8.1%; p = 0.989], late hypersensitivity [1.3% vs 1.2%; p = 0.895], paradoxical psoriasis [1% vs 1.5%; p = 0.187] and drug-induced lupus erythematosus [0.6% vs 0.7%; p = 0.947] were similar in elderly and younger patients. LOR rates were also similar between the two groups [20.5% vs 19.3%; p = 0.438]. In the logistic regression analysis, IFX monotherapy, extraintestinal manifestations and female gender were the only risk factors for IAEs, whereas IFX monotherapy, extraintestinal manifestations and Crohn's disease were risk factors for LOR. CONCLUSIONS: Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.
BACKGROUND AND AIMS: Immunomediated adverse events [IAEs] are the most frequently reported infliximab [IFX]-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. We aimed to compare the rates of IFX-related IAEs and loss of response [LOR] in elderly and younger patients. METHODS: Adult patients in the ENEIDA registry who had received a first course of IFX therapy were identified and grouped into two cohorts regarding age at the beginning of treatment [over 60 years and between 18 and 50 years]. The rates of IAEs and LOR were compared. RESULTS: In total, 939 patients [12%] who started IFX over 60 years of age and 6844 [88%] below 50 years of age were included. Elderly patients presented a higher proportion of AEs related to IFX [23.2% vs 19%; p = 0.002], infections [7.1% vs 4.3%; p < 0.001] and neoplasms [2.2% vs 0.5%; p < 0.001]. In contrast, the rates of IAEs [14.8% vs 14.8%; p = 0.999], infusion reactions [8.1% vs 8.1%; p = 0.989], late hypersensitivity [1.3% vs 1.2%; p = 0.895], paradoxical psoriasis [1% vs 1.5%; p = 0.187] and drug-induced lupus erythematosus [0.6% vs 0.7%; p = 0.947] were similar in elderly and younger patients. LOR rates were also similar between the two groups [20.5% vs 19.3%; p = 0.438]. In the logistic regression analysis, IFX monotherapy, extraintestinal manifestations and female gender were the only risk factors for IAEs, whereas IFX monotherapy, extraintestinal manifestations and Crohn's disease were risk factors for LOR. CONCLUSIONS: Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.