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

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dc.contributor.authorGarcía Castillo, María
dc.contributor.authorSierra-Mencía, Álvaro
dc.contributor.authorCaronna, Edoardo
dc.contributor.authorToledo-Alfocea, Daniel
dc.contributor.authorJaimes, Alex
dc.contributor.authorUrtiaga, Sarai
dc.contributor.authorCasas-Limón, Javier
dc.contributor.authorMuñoz-Vendrell, Albert
dc.contributor.authorSantos Lasaosa, Sonia
dc.contributor.authorGarcía Martín, Valvanuz
dc.contributor.authorMartín Ávila, Guillermo
dc.contributor.authorPolanco, Marcos
dc.contributor.authorVillar-Martínez, María Dolores
dc.contributor.authorTrevino-Peinado, Cristina
dc.contributor.authorRubio-Flores, Laura
dc.contributor.authorSánchez Soblechero, A
dc.contributor.authorPortocarrero Sánchez, Leonardo
dc.contributor.authorLuque-Buzo, Elisa
dc.contributor.authorLozano Ros, Alberto
dc.contributor.authorGago Veiga, Ana Beatriz
dc.contributor.authorDíaz de Terán, Javier
dc.contributor.authorRecio García, Andrea
dc.contributor.authorCanales Rodríguez, Javiera
dc.contributor.authorGómez García, Andrea
dc.contributor.authorGonzález Salaices, Marta
dc.contributor.authorCampoy, Sergio
dc.contributor.authorMínguez Olaondo, Ane
dc.contributor.authorManiataki, Stefania
dc.contributor.authorGonzález-Quintanilla, Vicente
dc.contributor.authorPorta-Etessam, Jesús
dc.contributor.authorCuadrado, María Luz
dc.contributor.authorGuerrero Peral, Ángel Luis
dc.contributor.authorPozo Rosich, Patricia
dc.contributor.authorRodríguez Vico, Jaime
dc.contributor.authorHuerta Villanueva, Mariano
dc.contributor.authorPascual, Julio
dc.contributor.authorGoadsby, Peter J.
dc.contributor.authorGonzález Martínez, Alicia
dc.date.accessioned2026-08-19T06:22:19Z
dc.date.available2026-08-19T06:22:19Z
dc.date.issued2026-06
dc.date.updated2026-08-19T06:22:19Z
dc.description.abstractObjective: 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. (Figure presented.).en
dc.description.sponsorshipInstituto de Salud Carlos III, Grant/AwardNumber: CM21/00178, JR23/00005 and PI24/01085; European Union (FEDER/European Regional Development Fund-“Away to make Europe”)en
dc.identifier.citationGarcía-Castillo, M. C., Sierra-Mencía, Á., Caronna, E., Toledo-Alfocea, D., Jaimes, A., Urtiaga, S., Casas-Limón, J., Muñoz-Vendrell, A., Santos-Lasaosa, S., García Martín, V., Martín Ávila, G., Polanco, M., Villar-Martínez, M. D., Trevino-Peinado, C., Rubio-Flores, L., Sánchez-Soblechero, A., Portocarrero Sánchez, L., Luque-Buzo, E., Lozano-Ros, A., et al. (2026). Evaluation of the effectiveness and safety of anti-CGRP monoclonal antibodies in patients with migraine and autoimmune diseases: IMMUNO-CGRP study. Headache, 66(6), 1330-1341. https://doi.org/10.1111/HEAD.70086
dc.identifier.doi10.1111/HEAD.70086
dc.identifier.eissn1526-4610
dc.identifier.issn0017-8748
dc.identifier.urihttps://hdl.handle.net/20.500.14454/6511
dc.language.isoeng
dc.publisherJohn Wiley and Sons Inc
dc.rights© 2026 The Author(s)
dc.subject.otherAnti-CGRP
dc.subject.otherAutoimmunity
dc.subject.otherImmunomodulatory
dc.subject.otherMigraine
dc.subject.otherNeuroinflammation
dc.subject.otherSafety
dc.titleEvaluation of the effectiveness and safety of anti-CGRP monoclonal antibodies in patients with migraine and autoimmune diseases: IMMUNO-CGRP studyen
dc.typejournal article
dcterms.accessRightsopen access
oaire.citation.endPage1341
oaire.citation.issue6
oaire.citation.startPage1330
oaire.citation.titleHeadache
oaire.citation.volume66
oaire.licenseConditionhttps://creativecommons.org/licenses/by-nc/4.0/
oaire.versionVoR
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