Comparative Efficacy and Immunogenicity of Infliximab and Adalimumab in Crohn’s Disease: A Prospective Cohort Study

<i>Background and Objectives</i>: Crohn's Disease (CD) is a chronic inflammatory condition often treated with anti-TNF agents such as infliximab (IFX) and adalimumab (ADA). This study compares the efficacy, immunogenicity, and pharmacokinetics of IFX and ADA over a 54-week period. <i>Materials and Methods</i>: A prospective, multicentre cohort study was conducted involving 72 patients with active CD (Crohn's disease activity index, CDAI > 150), who received treatment with either IFX (<i>n</i> = 42) or ADA (<i>n</i> = 30). <i>Results</i>: By week 54, treatment discontinuation occurred in 31% of IFX-treated patients (13/42) and 37% of ADA-treated patients (11/30), with no significant difference between groups (<i>p</i> = 0.612). Among those who completed the study, clinical remission (CDAI ≤ 150) was achieved in 65% of the IFX group and 95% of the ADA group (OR = 8.10; 95% CI = 1.10-20.11; <i>p</i> = 0.049). Loss of clinical response was more frequent in the IFX group (31%) than in the ADA group (10%), with an OR of 0.25 (95% CI: 0.06-0.97; <i>p</i> = 0.045). Fibrinogen levels declined in both groups, with a greater reduction observed in ADA-treated patients. The area under the ROC curve (AUC) for fibrinogen in distinguishing remission from active disease was 0.608 for IFX and 0.711 for ADA. Anti-drug antibodies were detected more frequently in IFX-treated patients (16.7%, 7/42) compared to those receiving ADA (6.7%, 2/30). <i>Conclusions</i>: Treatment with ADA demonstrated superior efficacy compared to IFX in maintaining clinical remission in CD, which was paralleled by a more effective normalization of fibrinogen levels (Clinical trial: GET-CRO-2010-01).

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Journal
Medicina
Published
2025-12-04
DOI
https://doi.org/10.3390/medicina61122165
Primary Topic
Inflammatory Bowel Disease
Type
article
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article

Comparative Efficacy and Immunogenicity of Infliximab and Adalimumab in Crohn’s Disease: A Prospective Cohort Study

José Luis Cabriada, Fernando Gomollón, Iván Guerra, Javier P. Gisbert et al.
Medicina
Inflammatory Bowel Disease
article

Comparative Efficacy and Immunogenicity of Infliximab and Adalimumab in Crohn’s Disease: A Prospective Cohort Study

José Luis Cabriada, Fernando Gomollón, Iván Guerra, Javier P. Gisbert, Laura Sempere, Miguel Á. Ortega, Patricia De Castro-Martinez, Joaquín Hinojosa, Marisa Iborra, Francisco Mesonero, María Dolores Martin‐Arranz, Julio Acero, Isabel Vera Mendoza, María Chaparro, Manuel Barreiro‐de Acosta, David A. Leon, Borja Hernández‐Breijo, Melchor Álvarez‐Mon, Luís Bujanda, Cristina Alba, Luis G. Guijarro, Ignacio Marín-Jiménez, Valle García-Sánchez
article en

Abstract

<i>Background and Objectives</i>: Crohn's Disease (CD) is a chronic inflammatory condition often treated with anti-TNF agents such as infliximab (IFX) and adalimumab (ADA). This study compares the efficacy, immunogenicity, and pharmacokinetics of IFX and ADA over a 54-week period. <i>Materials and Methods</i>: A prospective, multicentre cohort study was conducted involving 72 patients with active CD (Crohn's disease activity index, CDAI > 150), who received treatment with either IFX (<i>n</i> = 42) or ADA (<i>n</i> = 30). <i>Results</i>: By week 54, treatment discontinuation occurred in 31% of IFX-treated patients (13/42) and 37% of ADA-treated patients (11/30), with no significant difference between groups (<i>p</i> = 0.612). Among those who completed the study, clinical remission (CDAI ≤ 150) was achieved in 65% of the IFX group and 95% of the ADA group (OR = 8.10; 95% CI = 1.10-20.11; <i>p</i> = 0.049). Loss of clinical response was more frequent in the IFX group (31%) than in the ADA group (10%), with an OR of 0.25 (95% CI: 0.06-0.97; <i>p</i> = 0.045). Fibrinogen levels declined in both groups, with a greater reduction observed in ADA-treated patients. The area under the ROC curve (AUC) for fibrinogen in distinguishing remission from active disease was 0.608 for IFX and 0.711 for ADA. Anti-drug antibodies were detected more frequently in IFX-treated patients (16.7%, 7/42) compared to those receiving ADA (6.7%, 2/30). <i>Conclusions</i>: Treatment with ADA demonstrated superior efficacy compared to IFX in maintaining clinical remission in CD, which was paralleled by a more effective normalization of fibrinogen levels (Clinical trial: GET-CRO-2010-01).

MedicinaVol. 61(12)
Universidad de Alcalá (ES), Instituto Cajal (ES), Hospital Universitario La Paz (ES), Hospital General Universitario Gregorio Marañón (ES), Hospital Clínico San Carlos (ES), Hospital Universitari i Politècnic La Fe (ES), Complejo Hospitalario Universitario de Santiago (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Hospital de Galdakao (ES), Hospital Universitario Reina Sofía (ES), Instituto Ramón y Cajal de Investigación Sanitaria (ES), Hospital Universitario de La Princesa (ES), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES), Hospital Clínico Universitario Lozano Blesa (ES), Hospital General Universitario de Alicante Doctor Balmis (ES), Donostiako Unibertsitate Ospitalea (ES), Hospital Universitario de Fuenlabrada (ES), Hospital Virgen del Camino (ES), Hospital Universitario Ramón y Cajal (ES), Universidad Autónoma de Madrid (ES)
Comunidad de Madrid, Instituto de Salud Carlos III
Openalex Percentile: Top 60%
Inflammatory Bowel Disease
DOIOpen Access PDFOpenAlex
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