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

Viviana Nociti; Marina Romozzi; Pietro Annovazzi; Roberta Fantozzi; Carla Tortorella; Marco Vercellino; Luigi Francesco Iannone; Giovanna De Luca; Valentina Tomassini; Massimiliano Di Filippo; Lorena Lorefice; Giorgia Teresa Maniscalco; Damiano Paolicelli; Federica Pinardi; Marco Ronzoni; Claudio Marcello Solaro; Claudio Gasperini; Paolo Calabresi; Catello Vollono; Eleonora Cocco

doi:10.1016/j.jns.2025.123392

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

J Neurol Sci. 2025 Jan 8:469:123392. doi: 10.1016/j.jns.2025.123392. Online ahead of print.

Authors

Viviana Nociti¹, Marina Romozzi², Pietro Annovazzi³, Roberta Fantozzi⁴, Carla Tortorella⁵, Marco Vercellino⁶, Luigi Francesco Iannone⁷, Giovanna De Luca⁸, Valentina Tomassini⁸, Massimiliano Di Filippo⁹, Lorena Lorefice¹⁰, Giorgia Teresa Maniscalco¹¹, Damiano Paolicelli¹², Federica Pinardi¹³, Marco Ronzoni¹⁴, Claudio Marcello Solaro¹⁵, Claudio Gasperini⁵, Paolo Calabresi², Catello Vollono², Eleonora Cocco¹⁰

Affiliations

¹ 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. Electronic address: [email protected].
² 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.
³ Multiple Sclerosis Center, Hospital of Gallarate - ASST della Valle Olona, Gallarate, Italy.
⁴ Unit of Neurology - IRCCS Neuromed, Pozzilli, Isernia, Italy.
⁵ Multiple Sclerosis Center, Neurology Unit S. Camillo-Forlanini Hospital, Rome, Italy.
⁶ Department of Neuroscience, City of Health and Science University Hospital of Turin, Turin, Italy.
⁷ Section of Clinical Pharmacology and Oncology, Department of Health Sciences, University of Florence, Florence, Italy.
⁸ Multiple Sclerosis Center, Policlinico SS. Annunziata, Chieti, Italy.
⁹ Section of Neurology, Department of Medicine and Surgery, University of Perugia, Italy.
¹⁰ Multiple Sclerosis Center, Binaghi Hospital, ASL Cagliari, Italy; Department of Medical Sciences and Public Health, University of Cagliari, Italy.
¹¹ Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy.
¹² Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari "Aldo Moro", Bari, Italy.
¹³ IRCCS Istituto delle scienze neurologiche di Bologna, UOSI Riabilitazione Sclerosi Multipla, Bologna, Italy.
¹⁴ ASST Rhodense, Ospedale Garbagnate Milanese, Neurology Unit, Garbagnate Milanese, Italy.
¹⁵ Rehabilitation Department, Mons. L. Novarese, Moncrivello, Vercelli, Italy.

PMID: 39808882
DOI: 10.1016/j.jns.2025.123392

Abstract

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.

Keywords: CGRP; Migraine; Monoclonal antibodies; Multiple sclerosis; Pharmacokinetic; Pharmacological interactions.