Nociti Viviana, Romozzi Marina, Annovazzi Pietro, Fantozzi Roberta, Tortorella Carla, Vercellino Marco, Iannone Luigi Francesco, De Luca Giovanna, Tomassini Valentina, Di Filippo Massimiliano, Lorefice Lorena, Maniscalco Giorgia Teresa, Paolicelli Damiano, Pinardi Federica, Ronzoni Marco, Solaro Claudio Marcello, Gasperini Claudio, Calabresi Paolo, Vollono Catello, Cocco Eleonora
Dipartimento Universitario di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy; Neurologia, Dipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Dipartimento Universitario di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy; Neurologia, Dipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
J Neurol Sci. 2025 Feb 15;469:123392. doi: 10.1016/j.jns.2025.123392. Epub 2025 Jan 8.
Migraine affects up to 40% of people with multiple sclerosis (PwMS). This study aimed to evaluate the effectiveness and safety of the combination of antibodies (mAbs) against CGRP (anti-CGRP mAbs) with disease-modifying treatments (DMTs) for MS (mAb and non-mAbs) and their impact on MS disease course.
This retrospective, multicentric study included PwMS from 14 MS Centers, treated with an anti-CGRP mAb and a stable treatment with DMTs. MS outcome measures included clinical relapses, EDSS score, and MRI activity from the year before starting anti-CGRP mAbs at the time of initiation (baseline) and last follow-up. Migraine outcomes included reductions in Monthly Headache Days (MHDs) and analgesic use. Adverse events (AEs) were recorded.
Twenty-five patients were included (mean age of 39.4 ± 9.7 years). Nine PwMS (36.0%) were treated with non-mAb DMTs and 16 (64.0%) with mAb DMTs. During the concurrent treatment, six patients (24.0%) stopped anti-CGRP mAbs after 12.7 ± 11.6 months due to ineffectiveness (n = 3) migraine sustained improvement (n = 2) and AEs (n = 1). MHDs significantly decreased from baseline (22.0 ± 8.2) to the last follow-up (11.5 ± 13.7) (p = 0.002). EDSS score did not significantly change from the year before initiating anti-CGRP mAb (1.9 ± 1.4) to baseline (1.9 ± 1.4) and last follow-up (1.9 ± 1.5)(p = 0.497). Two patients (8.0%) had a clinical relapse, and one (4.0%) had MRI activity during treatment with anti-CGRP mAbs. Overall, DMTs were discontinued in two patients (8%). Mild AEs were reported in 2 PwMS (8.0%), none leading to discontinuation.
Long-term treatment with anti-CGRP mAbs and DMTs for MS showed safety and effectiveness with no significant effect on MS disease course.
偏头痛影响多达40%的多发性硬化症患者（PwMS）。本研究旨在评估抗降钙素基因相关肽抗体（抗CGRP单克隆抗体）与多发性硬化症疾病修饰治疗（DMTs，包括单克隆抗体和非单克隆抗体）联合使用的有效性和安全性，以及它们对多发性硬化症病程的影响。
这项回顾性多中心研究纳入了来自14个多发性硬化症中心的PwMS患者，这些患者接受了抗CGRP单克隆抗体治疗以及稳定的DMTs治疗。多发性硬化症的结局指标包括临床复发、扩展残疾状态量表（EDSS）评分以及从开始使用抗CGRP单克隆抗体前一年到开始治疗时（基线）和最后一次随访时的磁共振成像（MRI）活动情况。偏头痛结局指标包括每月头痛天数（MHDs）的减少和镇痛药使用量的减少。记录不良事件（AEs）。
共纳入25例患者（平均年龄39.4±9.7岁）。9例PwMS患者（36.0%）接受非单克隆抗体DMTs治疗，16例（64.0%）接受单克隆抗体DMTs治疗。在联合治疗期间，6例患者（24.0%）在12.7±11.6个月后因无效（n = 3）、偏头痛持续改善（n = 2）和不良事件（n = 1）而停用抗CGRP单克隆抗体。MHDs从基线时的（22.0±8.2）显著降至最后一次随访时的（11.5±13.7）（p = 0.002）。从开始使用抗CGRP单克隆抗体前一年（1.9±1.4）到基线时（1.9±1.4）以及最后一次随访时（1.9±1.5），EDSS评分无显著变化（p = 0.497）。2例患者（8.0%）出现临床复发，1例（4.0%）在接受抗CGRP单克隆抗体治疗期间有MRI活动。总体而言，2例患者（8%）停用了DMTs。2例PwMS患者（8.0%）报告了轻度不良事件，均未导致停药。
抗CGRP单克隆抗体与DMTs联合用于多发性硬化症的长期治疗显示出安全性和有效性，对多发性硬化症病程无显著影响。
