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.


Journal

Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676

Informations de publication

Date de publication:
14 Jul 2022
Historique:
received: 17 08 2021
revised: 19 10 2021
accepted: 01 12 2021
pubmed: 6 12 2021
medline: 19 7 2022
entrez: 5 12 2021
Statut: ppublish

Résumé

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. 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. 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. Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
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 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 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 CONCLUSIONS
Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients.

Identifiants

pubmed: 34864947
pii: 6448705
doi: 10.1093/ecco-jcc/jjab213
doi:

Substances chimiques

Gastrointestinal Agents 0
Infliximab B72HH48FLU

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

946-953

Subventions

Organisme : AbbVie
Organisme : Galápagos
Organisme : Janssen
Organisme : Biogen
Organisme : Takeda Foundation
Organisme : Pfizer

Investigateurs

Margalida Calafat (M)
Míriam Mañosa (M)
Elena Ricart (E)
Pilar Nos (P)
Eva Iglesias (E)
Isabel Vera (I)
Antonio López-Sanromán (A)
Jordi Guardiola (J)
Carlos Taxonera (C)
Miguel Mínguez (M)
M Dolores Martín-Arranz (MD)
Luisa de Castro (L)
Ruth de Francisco (R)
Montserrat Rivero (M)
Esther Garcia-Planella (E)
Xavier Calvet (X)
Santiago García-López (S)
Lucía Márquez (L)
Fernando Gomollón (F)
Jesús Barrio (J)
Maria Esteve (M)
Fernando Muñoz (F)
Javier P Gisbert (JP)
Ana Gutiérrez (A)
Joaquín Hinojosa (J)
Federico Argüelles-Arias (F)
David Busquets (D)
Luís Bujanda (L)
JoséL Pérez-Calle (J)
Beatriz Sicilia (B)
Olga Merino (O)
Pilar Martínez (P)
Fernando Bermejo (F)
Rufo Lorente (R)
Manuel Barreiro-de Acosta (M)
Cristina Rodríguez (C)
Mariana Fe García-Sepulcre (M)
David Monfort (D)
Patricia Romero (P)
Carlos Tardillo (C)
Óscar Roncero (Ó)
Jordina Llaó (J)
Guillermo Alcaín (G)
Núria Rull (N)
Mónica Sierra-Ausín (M)
Luís Fernández-Salazar (L)
Jair Morales-Alvarado (J)
Mercè Navarro-Llavat (M)
Miguel A Montoro (MA)
Carmen Muñoz-Villafranca (C)
Alfredo J Lucendo (AJ)
Manuel Van Domselaar (M)
Ainhoa Rodríguez-Pescador (A)
Laura Ramos (L)
Sandra Estrecha (S)
Pedro Almela (P)
Ramón Pajares (R)
Sam Khorrami (S)
Rosa Eva Madrigal (R)
Eva Sesé (E)
Ana Mª Trapero (AM)
Jesús Legido (J)
Pau Gilabert (P)
Fiorella Cañete (F)
Eugeni Domènech (E)

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Auteurs

Margalida Calafat (M)

H.U. Germans Trias i Pujol, Badalona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.

Míriam Mañosa (M)

H.U. Germans Trias i Pujol, Badalona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.

Elena Ricart (E)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H. Clínic Barcelona, Barcelona; IDIBAPS, Barcelona, Spain.

Pilar Nos (P)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H. Universitari La Fe, València, Spain.

Eva Iglesias-Flores (E)

H. Reina Sofía, Córdoba, Spain.

Isabel Vera (I)

H.U. Puerta de Hierro Majadahonda, Madrid, Spain.

Antonio López-Sanromán (A)

H.U. Ramón y Cajal, Madrid, Spain.

Jordi Guardiola (J)

H.U. Bellvitge (L'Hospitalet de Llobregat), Spain.

Carlos Taxonera (C)

H.U. Clínico San Carlos, Madrid; Instituto de investigación del Hospital Clínico San Carlos, Madrid, Spain.

Miguel Mínguez (M)

H.U. Clínico de València, València; Universitat de València, València, Spain.

M Dolores Martín-Arranz (MD)

H.U. La Paz, Madrid, Spain.

Luisa de Castro (L)

Complexo H.U, de Vigo, Vigo, Spain.

Ruth de Francisco (R)

H.U. Central de Asturias and Instituto de Investigación Biosanitaria del principado de Asturias (ISPA), Oviedo, Spain.

Montserrat Rivero (M)

H.U. Marqués de Valdecilla, Santander; IDIVAL, Santander, Spain.

Esther Garcia-Planella (E)

H.U. de la Santa Creu i Sant Pau , Barcelona, Spain.

Xavier Calvet (X)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H.U. Parc Taulí , Sabadell, Spain.

Santiago García-López (S)

H.U. Miguel Servet , Zaragoza, Spain.

Lucía Márquez (L)

Servei de Digestiu, Hospital del Mar, Barcelona and IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Fernando Gomollón (F)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H. Clínico Lozano Blesa, Zaragoza; Instituto de Investigaciones Sanitarias de Aragón.

Jesús Barrio (J)

Servicio de Gastroenterología. Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain.

Maria Esteve (M)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H. Universitari Mútua Terrassa, Terrassa, Spain.

Fernándo Muñoz (F)

H.U.Salamanca , Salamanca, Spain.

Javier P Gisbert (JP)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H. U. de la Princesa, Madrid; Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM).

Ana Gutiérrez (A)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
H.G.U.Alicante, Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL) , Spain.

Joaquín Hinojosa (J)

Hospital Vithas 9 de Octubre, València, Spain.

Federico Argüelles-Arias (F)

Servicio de Digestivo, Hospital Universitario Virgen Macarena, Sevilla; Profesor Facultad Medicina de la Universidad de Sevilla, Sevilla, Spain.

David Busquets (D)

H. U. Girona Dr. J. Trueta, Girona, Spain.

Luís Bujanda (L)

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.
Instituto Biodonostia, Universidad del País Vasco (UPV/EHU), San Sebastián, Spain.

José L Pérez-Calle (JL)

H.U. Fundación de Alcorcón, Alcorcón, Spain.

Beatriz Sicilia (B)

Hospital Universitario de Burgos, Burgos, Spain.

Olga Merino (O)

H. de Cruces, Barakaldo, Spain.

Pilar Martínez (P)

H. 12 de Octubre, Madrid, Spain.

Fernando Bermejo (F)

Hospital Universitario de Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz (IdiPAZ), Madrid, Spain.

Rufo Lorente (R)

H.General de Ciudad Real, Ciudad Real, Spain.

Manuel Barreiro-de Acosta (M)

C.H.U. Clínico Santiago, Santiago de Compostela, Spain.

Cristina Rodríguez (C)

C.H. de Navarra, Pamplona, Spain.

Mariana Fe García-Sepulcre (M)

H.G. Elche, Elche, Spain.

David Monfort (D)

Consorci Sanitari de Terrassa, Terrassa, Spain.

Fiorella Cañete (F)

H.U. Germans Trias i Pujol, Badalona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.

Eugeni Domènech (E)

H.U. Germans Trias i Pujol, Badalona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.

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