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Background <p>Preclinical evidence supports the immunoregulatory role of calcitonin gene-related peptide (CGRP) in migraine pathophysiology. The increasing use of anti-CGRP therapies in patients with migraine and other comorbidities raises the question whether the potential use of anti-CGRP monoclonal antibodies (CGRP-mAbs) therapies in combination with other immunological therapies is effective and safe.</p> Methods <p>This multicenter study included patients with migraine receiving CGRP-mAbs combined with immunosuppressive and immunomodulatory treatments. Clinical and demographic data, treatment history, laboratory markers and treatment-emergent adverse events (TEAEs) were analyzed. Effectiveness outcomes included the change in monthly migraine days (MMD) and monthly headache days (MHD) at 3, 6, 9 and 12&#xa0;months, alongside the &gt; 50% response rate. Moreover, autoimmune disease progression was also evaluated. We explored differences between patients with and without autoimmune disease activation.</p> Results <p>Among 89 patients, there were 80 (90%) females with a mean age of 50&#xa0;years (SD: 11), who had a high prevalence of psychiatric comorbidities (anxiety 44%, depression 49%) and medication overuse (68%). Patients receiving immunological treatments experienced significant reductions in MMD and MHD, with MMD decreasing from 16 (SD: 7) at baseline to 9 (SD: 8) at 6&#xa0;months, and MHD dropping from 23 (SD: 8) to 17 (SD: 11). A 50% response in MMD was achieved by 46% at 6&#xa0;months. TEAEs were reported in 28%, most commonly constipation (16%) and dizziness (9%).</p> Conclusions <p>CGRP-mAbs therapies combined with immunological treatments appear effective and safe in patients with autoimmune diseases. Larger prospective studies are necessary to confirm these findings and optimize management strategies.</p>

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Concomitant anti-CGRP and immunomodulatory treatments in patients with migraine: towards integrated management strategies

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月3日

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

摘要

Background

Preclinical evidence supports the immunoregulatory role of calcitonin gene-related peptide (CGRP) in migraine pathophysiology. The increasing use of anti-CGRP therapies in patients with migraine and other comorbidities raises the question whether the potential use of anti-CGRP monoclonal antibodies (CGRP-mAbs) therapies in combination with other immunological therapies is effective and safe.

Methods

This multicenter study included patients with migraine receiving CGRP-mAbs combined with immunosuppressive and immunomodulatory treatments. Clinical and demographic data, treatment history, laboratory markers and treatment-emergent adverse events (TEAEs) were analyzed. Effectiveness outcomes included the change in monthly migraine days (MMD) and monthly headache days (MHD) at 3, 6, 9 and 12 months, alongside the > 50% response rate. Moreover, autoimmune disease progression was also evaluated. We explored differences between patients with and without autoimmune disease activation.

Results

Among 89 patients, there were 80 (90%) females with a mean age of 50 years (SD: 11), who had a high prevalence of psychiatric comorbidities (anxiety 44%, depression 49%) and medication overuse (68%). Patients receiving immunological treatments experienced significant reductions in MMD and MHD, with MMD decreasing from 16 (SD: 7) at baseline to 9 (SD: 8) at 6 months, and MHD dropping from 23 (SD: 8) to 17 (SD: 11). A 50% response in MMD was achieved by 46% at 6 months. TEAEs were reported in 28%, most commonly constipation (16%) and dizziness (9%).

Conclusions

CGRP-mAbs therapies combined with immunological treatments appear effective and safe in patients with autoimmune diseases. Larger prospective studies are necessary to confirm these findings and optimize management strategies.