偏头痛患者的降钙素基因相关肽（CGRP）拮抗剂与免疫调节联合治疗：走向综合管理策略

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

作者信息

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

机构信息

Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Madrid, Spain.

Hospital Universitario de la Princesa, Madrid, Spain.

出版信息

J Neurol. 2025 Jun 3;272(6):443. doi: 10.1007/s00415-025-13177-y.

DOI:10.1007/s00415-025-13177-y

PMID:40461909

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12134006/

Abstract

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.

摘要

背景

临床前证据支持降钙素基因相关肽（CGRP）在偏头痛病理生理学中的免疫调节作用。偏头痛及其他合并症患者中抗CGRP疗法的使用日益增加，这引发了一个问题，即抗CGRP单克隆抗体（CGRP - mAbs）疗法与其他免疫疗法联合使用是否有效且安全。

方法

这项多中心研究纳入了接受CGRP - mAbs联合免疫抑制和免疫调节治疗的偏头痛患者。分析了临床和人口统计学数据、治疗史、实验室指标以及治疗中出现的不良事件（TEAE）。有效性指标包括3、6、9和12个月时每月偏头痛天数（MMD）和每月头痛天数（MHD）的变化，以及>50%的缓解率。此外，还评估了自身免疫性疾病的进展情况。我们探讨了自身免疫性疾病激活患者与未激活患者之间的差异。

结果

89例患者中，有80例（90%）为女性，平均年龄50岁（标准差：11），精神合并症（焦虑44%，抑郁49%）和药物过度使用（68%）的患病率较高。接受免疫治疗的患者MMD和MHD显著降低，MMD从基线时的16天（标准差：7）降至6个月时的9天（标准差：8），MHD从23天（标准差：8）降至17天（标准差：11）。6个月时，46%的患者MMD有50%的缓解。28%的患者报告了TEAE，最常见的是便秘（16%）和头晕（9%）。