Impact of multiple treatment cycles with anti-CGRP monoclonal antibodies on migraine course: focus on discontinuation periods. Insights from the multicenter, prospective, I-GRAINE study.

Anti-CGRP mAbs Discontinuation Disease-modifier Migraine Multiple treatments Treatment

Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
12 Feb 2024
Historique:
received: 27 12 2023
accepted: 13 01 2024
revised: 06 01 2024
medline: 12 2 2024
pubmed: 12 2 2024
entrez: 11 2 2024
Statut: aheadofprint

Résumé

While a single 12-month treatment cycle (TrC) with anti-CGRP mAbs is not disease-modifying for most patients, there is limited understanding of the effects of multiple TrCs on migraine course. We evaluated whether a second TrC might modify the migraine course by comparing the occurrence of migraine relapse after discontinuation of the second TrC to that following the cessation of the first TrC. In a real-life, multicenter, prospective study we considered all consecutive patients diagnosed with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and treated with any anti-CGRP mAbs for ≥ 2 consecutive 12-month TrCs who were responders at week 12. The primary endpoint was the change in monthly migraine days (MMD) for HFEM or monthly headache days (MHD) for CM at the first month of treatment discontinuation after the second TrC (D2) compared to the first TrC (D1). Secondary endpoints included variations in monthly analgesic medications (MAM), Numeric Rating Scale (NRS), and Headache Impact Test (HIT-6) scores, ≥ 50%, ≥ 75%, and 100% response rates, and relapse from episodic migraine to CM and from no-medication overuse (MO) to MO at D2 vs. D1. One-hundred-seventy-eight patients completed two 12-month TrCs with anti-CGRP mAbs. At D2, patients experienced a significant reduction in MMD (- 0.6, p = 0.028), MHD (- 2.6, p < 0.001), monthly analgesic medications (- 2.0, p < 0.001), and HIT-6 score (- 2.2, p < 0.001) compared to D1, indicating improved effectiveness. The ≥ 50% response rate at weeks 45-48 during the first TrC was 95.5%, while at weeks 45-48 of the second TrC was 99.4%. Corresponding rates at D1 was 20.2% whereas at D2 was 51.6% (p < 0.0001). No statistical difference emerged in ≥ 75% and 100% responders. The relapse rate from episodic migraine to CM at D2 was lower than at D1 (12.3% vs 30.4%; p = 0.0002) Fewer patients experienced relapse from no-MO to MO at D2 compared to D1 (29.5% vs 68.7%; p = 0.00001). A second TrC with anti-CGRP mAbs demonstrated clinical improvements compared to the first one, as indicated by a milder migraine relapse at D2 compared to D1. Multiple TrCs with anti-CGRP mAbs could progressively modify migraine evolution by reducing CGRP-dependent neuroinflammatory nociceptive inputs to the brain.

Identifiants

pubmed: 38342785
doi: 10.1007/s00415-024-12192-9
pii: 10.1007/s00415-024-12192-9
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

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Auteurs

Piero Barbanti (P)

Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy. piero.barbanti@sanraffaele.it.
San Raffaele University, Rome, Italy. piero.barbanti@sanraffaele.it.

Cinzia Aurilia (C)

Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy.

Gabriella Egeo (G)

Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy.

Stefania Proietti (S)

Clinical and Molecular Epidemiology, IRCCS San Raffaele, Rome, Italy.

Paola Torelli (P)

Unit of Neurology, Department of Medicine and Surgery, Headache Center, University of Parma, Parma, Italy.

Florindo d'Onofrio (F)

Headache Center Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy.

Antonio Carnevale (A)

Headache Center San Filippo Neri Hospital, Rome, Italy.

Sofia Tavani (S)

Catholic University of Sacred Heart Rome, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.

Bianca Orlando (B)

Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy.

Giulia Fiorentini (G)

Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy.
San Raffaele University, Rome, Italy.

Bruno Colombo (B)

Headache Unit, Department of Neurology, Scientific Institute San Raffaele Hospital, Vita-Salute University, Milan, Italy.

Massimo Filippi (M)

Headache Unit, Department of Neurology, Scientific Institute San Raffaele Hospital, Vita-Salute University, Milan, Italy.

Stefano Bonassi (S)

San Raffaele University, Rome, Italy.
Clinical and Molecular Epidemiology, IRCCS San Raffaele, Rome, Italy.

Sabina Cevoli (S)

IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.

Classifications MeSH