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Predictive factors of response to anti-CGRP pathway drugs in people with multiple sclerosis

Nociti V, Cesarano S, Romozzi M, Totaro R, Albanese M, Casalena A, Annovazzi P, Fantozzi R et al.

The journal of headache and pain, 2026

46 participants

Abstract

Background: Migraine is common in people with multiple sclerosis (PwMS) and substantially contributes to disability and impaired quality of life. Although (CGRP)-targeting therapies have reshaped migraine prevention, evidence on their use in PwMS remains scarce, particularly in people receiving concomitant disease-modifying therapies (DMTs).

Methods: We retrospectively collected data from 17 Italian multiple sclerosis (MS) centers on adult PwMS with comorbid migraine treated with anti-CGRP monoclonal antibodies or gepants in addition to stable DMTs. Monthly headache days (MHDs) and total number of analgesics per month were compared between treatment initiation and last follow-up. MS activity was assessed through clinical relapses, Expanded Disability Status Scale (EDSS), and MRI findings. A ≥ 50% reduction in MHDs defined treatment response. Multivariate regression models were used to explore predictors of response to anti-CGRP therapies.

Results: Fifty-four patients were included (46 women; mean age 42.3 years; 85% relapsing MS). Baseline MHDs averaged 19.87 ± 6.97 and declined to 11.40 ± 9.35 at follow-up (p < 0.001), with a parallel decrease in analgesic use (p < 0.001). Responder rate at the last follow-up was 53.7%. MS disease activity remained stable, with no significant changes in relapse rate, EDSS score, or MRI activity. Higher baseline headache burden was associated with greater reduction in MHDs (β=+0.685, p < 0.001), whereas longer MS duration predicted poorer…

How strong is the evidence?

Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 46 participants or records.

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