Evaluation of the effectiveness and safety of <scp>anti‐CGRP</scp> monoclonal antibodies in patients with migraine and autoimmune diseases: <scp>IMMUNO</scp> ‐ <scp>CGRP study</scp>

OBJECTIVE: This study aimed to evaluate demographic characteristics, treatment effectiveness, and safety outcomes in patients with migraine undergoing anti-calcitonin gene-related peptide (CGRP) treatments regarding the presence of autoimmune diseases. BACKGROUND: CGRP has an important role in migraine pathophysiology through neuronal modulation in the trigeminovascular nociceptive system and activation of neuro-inflammatory cascades. We hypothesized that autoimmune diseases may influence treatment response and safety profiles in patients with migraine treated with anti-CGRP treatments. METHODS: This was a retrospective multicenter, age- and sex-matched cohort study in headache units/headache clinics in Spain and United Kingdom between May 2024 and May 2025 including patients treated with CGRP monoclonal antibodies from prospectively collected cohorts. Patients were assessed for demographics, migraine-related characteristics, treatment effectiveness (monthly migraine days [MMD] and/or monthly headache days [MHD]), and safety outcomes. The main outcome was the effectiveness measured by ≥50% response rate in MMD between the two groups. Secondary outcomes included other effectiveness measurements regarding the number of MMD and MHD and treatment emerging adverse events. RESULTS: A total of 388 patients with migraine under anti-CGRP treatments (194 with autoimmune diseases and 194 age- and sex-matched controls without autoimmune diseases) were included. The proportion of patients achieving a ≥50% response rate in MMD was higher in patients without autoimmune diseases at 6 (69% vs. 53%; p = 0.006) and 9 months (74% vs. 52%; p = 0.006). Treatment emerging adverse events were comparable between the two groups (35% vs. 38%; p = 0.575). Patients with autoimmune disease had a significantly lower likelihood of achieving a ≥50% response in MMD compared with those without autoimmune disease (adjusted odds ratio, 0.61; 95% confidence interval, 0.44-0.85; p = 0.006), independent of comorbid depression and medication overuse. CONCLUSIONS: Our study shows that anti-CGRP treatments are effective and safe for patients with migraine regardless the presence of autoimmune diseases, although an increased treatment response in patient without autoimmune disorders compared to patients with autoimmune disorders was observed. These findings highlight the need for early intervention, tailored strategies, and vigilant monitoring in patients with migraine and autoimmune disorders. Further research should explore immunomodulatory approaches to enhance outcomes.

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Publication Details

Journal
Headache The Journal of Head and Face Pain
Published
2026-04-01
DOI
https://doi.org/10.1111/head.70086
Primary Topic
Migraine and Headache Studies
Type
article
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article

Evaluation of the effectiveness and safety of anti‐CGRP monoclonal antibodies in patients with migraine and autoimmune diseases: IMMUNO ‐ CGRP study

Alicia González‐Martínez, Ane Mínguez‐Olaondo, Sarai Urtiaga, Marcos Polanco et al.
Headache The Journal of Head and Face Pain
Migraine and Headache Studies
article

Evaluation of the effectiveness and safety of anti‐CGRP monoclonal antibodies in patients with migraine and autoimmune diseases: IMMUNO ‐ CGRP study

Alicia González‐Martínez, Ane Mínguez‐Olaondo, Sarai Urtiaga, Marcos Polanco, Guillermo Martín-Ávila, J. Porta‐Etessam, Javier Casas‐Limón, Patricia Pozo‐Rosich, Sergio Campoy, Cristina Trevino‐Peinado, Maria Dolores Villar‐Martínez, Alberto Lozano‐Ros, Marta González Salaíces, Elisa Luque‐Buzo, Andrea Gómez García, Jaime Rodríguez‐Vico, Edoardo Caronna, Vince Martin, Andrea Recio García, Stefania Maniataki, Angel Luis Guerrero Peral, Alex Jaimes, Antonio Sánchez‐Soblechero, Julio Pascual, Ana Beatriz Gago‐Veiga, María‐Luz Cuadrado, Javiera Canales Rodríguez, María Clara García‐Castillo, Peter J. Goadsby, Mariano Huerta‐Villanueva, Leonardo Portocarrero Sánchez, Albert Muñoz‐Vendrell, Vicente González‐Quintanilla, Laura Rubio‐Flores, Sonia Santos‐Lasaosa, Javier Díaz‐De‐Terán, Álvaro Sierra‐Mencía, Daniel Toledo‐Alfocea
article en

Abstract

OBJECTIVE: This study aimed to evaluate demographic characteristics, treatment effectiveness, and safety outcomes in patients with migraine undergoing anti-calcitonin gene-related peptide (CGRP) treatments regarding the presence of autoimmune diseases. BACKGROUND: CGRP has an important role in migraine pathophysiology through neuronal modulation in the trigeminovascular nociceptive system and activation of neuro-inflammatory cascades. We hypothesized that autoimmune diseases may influence treatment response and safety profiles in patients with migraine treated with anti-CGRP treatments. METHODS: This was a retrospective multicenter, age- and sex-matched cohort study in headache units/headache clinics in Spain and United Kingdom between May 2024 and May 2025 including patients treated with CGRP monoclonal antibodies from prospectively collected cohorts. Patients were assessed for demographics, migraine-related characteristics, treatment effectiveness (monthly migraine days [MMD] and/or monthly headache days [MHD]), and safety outcomes. The main outcome was the effectiveness measured by ≥50% response rate in MMD between the two groups. Secondary outcomes included other effectiveness measurements regarding the number of MMD and MHD and treatment emerging adverse events. RESULTS: A total of 388 patients with migraine under anti-CGRP treatments (194 with autoimmune diseases and 194 age- and sex-matched controls without autoimmune diseases) were included. The proportion of patients achieving a ≥50% response rate in MMD was higher in patients without autoimmune diseases at 6 (69% vs. 53%; p = 0.006) and 9 months (74% vs. 52%; p = 0.006). Treatment emerging adverse events were comparable between the two groups (35% vs. 38%; p = 0.575). Patients with autoimmune disease had a significantly lower likelihood of achieving a ≥50% response in MMD compared with those without autoimmune disease (adjusted odds ratio, 0.61; 95% confidence interval, 0.44-0.85; p = 0.006), independent of comorbid depression and medication overuse. CONCLUSIONS: Our study shows that anti-CGRP treatments are effective and safe for patients with migraine regardless the presence of autoimmune diseases, although an increased treatment response in patient without autoimmune disorders compared to patients with autoimmune disorders was observed. These findings highlight the need for early intervention, tailored strategies, and vigilant monitoring in patients with migraine and autoimmune disorders. Further research should explore immunomodulatory approaches to enhance outcomes.

Headache The Journal of Head and Face Pain
Universidad de Valladolid (ES), Universidad de Cantabria (ES), Universidad de Deusto (ES), Pontificia Universidad Católica de Chile (CL), King's College London (GB), Neurosciences Institute (US), Hospital Universitario La Paz (ES), Bellvitge University Hospital (ES), Hospital General Universitario Gregorio Marañón (ES), Hospital Clínico San Carlos (ES), Research Institute Hospital 12 de Octubre (ES), Institut d'Investigació Biomédica de Bellvitge (ES), Hospital Universitario de Torrejón (ES), Marqués de Valdecilla University Hospital (ES), Biogipuzkoa Health Research Institute (ES), Hospital Universitario Fundación Alcorcón (ES), Hospital Universitario 12 De Octubre (ES), Vall d'Hebron Institut de Recerca (ES), Hospital Universitario de Getafe (ES), Instituto de Investigación Marqués de Valdecilla (ES), Vall d'Hebron Hospital Universitari (ES), Hospital Universitario Fundación Jiménez Díaz (ES), Hospital Universitario de La Princesa (ES), Hospital Clínico Universitario Lozano Blesa (ES), Donostiako Unibertsitate Ospitalea (ES), Instituto de Biomedicina y Genética Molecular de Valladolid (ES), Onkologikoa (ES), Universidad Alfonso X el Sabio (ES), Hospital Clínico Universitario de Valladolid (ES), Hospital Universitario Severo Ochoa (ES), Universidad Autónoma de Madrid (ES), King Abdullah University of Science and Technology (SA)
European Commission, Instituto de Salud Carlos III, European Regional Development Fund
Good health and well-being
Openalex Percentile: Top 31%
Migraine and Headache Studies
DOIOpen Access PDFOpenAlex
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