Journal of the neurological sciences · 2025
Effectiveness, safety, and impact on multiple sclerosis course of anti-CGRP monoclonal antibodies.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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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
Аннотация
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.
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.