Effectiveness, safety, and impact on multiple sclerosis course of anti-CGRP monoclonal antibodies

Background: 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. Methods: 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. Results: 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. Conclusions: Long-term treatment with anti-CGRP mAbs and DMTs for MS showed safety and effectiveness with no significant effect on MS disease course.