Risk of Immunomediated Adverse Events and Loss of Response to Infliximab in Elderly Patients with Inflammatory Bowel Disease: A Cohort Study of the ENEIDA Registry
Authors: Calafat Margalida , Mañosa Míriam , Ricart Elena , Nos Pilar , Iglesias-Flores Eva , Vera Isabel , López-Sanromán Antonio , Guardiola Jordi , Taxonera Carlos , Mínguez Miguel , Martín-Arranz M Dolores , de Castro Luisa , de Francisco Ruth , Rivero Montserrat , Garcia-Planella Esther , Calvet Xavier , García-López Santiago , Márquez Lucía , Gomollón Fernando , Barrio Jesús , Esteve Maria , Muñoz Fernándo , Gisbert Javier P , Gutiérrez Ana , Hinojosa Joaquín , Argüelles-Arias Federico , Busquets David , Bujanda Luís , Pérez-Calle José L , Sicilia Beatriz , Merino Olga , Martínez Pilar , Bermejo Fernando , Lorente Rufo , Barreiro-de Acosta Manuel , Rodríguez Cristina , Fe García-Sepulcre Mariana , Monfort David , Cañete Fiorella , Domènech Eugeni ,   ENEIDA Study Group of GETECCU, Calafat Margalida , Mañosa Míriam , Ricart Elena , Nos Pilar , Iglesias Eva , Vera Isabel , López-Sanromán Antonio , Guardiola Jordi , Taxonera Carlos , Mínguez Miguel , Martín-Arranz M Dolores , de Castro Luisa , de Francisco Ruth , Rivero Montserrat , Garcia-Planella Esther , Calvet Xavier , García-López Santiago , Márquez Lucía , Gomollón Fernando , Barrio Jesús , Esteve Maria , Muñoz Fernando , Gisbert Javier P , Gutiérrez Ana , Hinojosa Joaquín , Argüelles-Arias Federico , Busquets David , Bujanda Luís , Pérez-Calle JoséL , Sicilia Beatriz , Merino Olga , Martínez Pilar , Bermejo Fernando , Lorente Rufo , Barreiro-de Acosta Manuel , Rodríguez Cristina , Fe García-Sepulcre Mariana , Monfort David , Romero Patricia , Tardillo Carlos , Roncero Óscar , Llaó Jordina , Alcaín Guillermo , Rull Núria , Sierra-Ausín Mónica , Fernández-Salazar Luís , Morales-Alvarado Jair , Navarro-Llavat Mercè , Montoro Miguel A , Muñoz-Villafranca Carmen , Lucendo Alfredo J , Van Domselaar Manuel , Rodríguez-Pescador Ainhoa , Ramos Laura , Estrecha Sandra , Almela Pedro , Pajares Ramón , Khorrami Sam , Eva Madrigal Rosa , Sesé Eva , Trapero Ana Mª , Legido Jesús , Gilabert Pau , Cañete Fiorella , Domènech Eugeni 
Published: December 2021

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 &lt; 0.001] and neoplasms [2.2% vs 0.5%; p &lt; 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.