Evidence map›Paper›PMID 39862304›Full record

ArticleJournal of neurology2025

Three-year treatment with anti-CGRP monoclonal antibodies modifies migraine course: the prospective, multicenter I-GRAINE study.

Piero Barbanti, Cinzia Aurilia, Paola Torelli, Gabriella Egeo, Florindo d'Onofrio, Cinzia Finocchi, Antonio Carnevale, Giovanna Viticchi, Marco Russo, Simone Quintana and 10 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Cost-efficacy evaluation of a mindfulness-based program added to treatment as usual for the treatment of chronic migraine associated to medication overuse headache.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Piero Barbanti *Headache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy. piero.barbanti@sanraffaele.it.ORCID http://orcid.org/0000-0002-5670-3755
Cinzia Aurilia *Headache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
Paola TorelliUnit of Neurology, Department of Medicine and Surgery, Headache Center, University of Parma, Parma, Italy.
Gabriella EgeoHeadache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
Florindo d'OnofrioHeadache Center Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy.
Cinzia FinocchiHeadache Center, San Paolo Hospital, ASL 2, Savona, Italy.
Antonio CarnevaleHeadache Center San Filippo Neri Hospital, Rome, Italy.
Giovanna ViticchiNeurological Clinic, Marche Polytechnic University, Ancona, Italy.
Marco RussoHeadache Centre, Neurology Unit, Neuromotor and Rehabilitation Department, Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia, Italy.
Simone QuintanaHeadache Centre, Neurology Unit, Neuromotor and Rehabilitation Department, Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia, Italy.
Bianca OrlandoHeadache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
Giulia FiorentiniHeadache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
Roberta MessinaDepartment of Neurology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Marco BartoliniNeurological Clinic, Marche Polytechnic University, Ancona, Italy.
Francesca PistoiaDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Massimo FilippiDepartment of Neurology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Stefano BonassiClinical and Molecular Epidemiology, IRCCS San Raffaele Roma, Rome, Italy.
Sabina Cevoli *IRCCS Istituto Delle Scienze Neurologiche Di Bologna, Bologna, Italy.
Alice Mannocci *Clinical and Molecular Epidemiology, IRCCS San Raffaele Roma, Rome, Italy.
Italian Migraine Registry (I-GRAINE) study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine whether extending anti-CGRP mAb treatment beyond 3 years influences migraine course, we analyzed migraine frequency during the first month of treatment discontinuation following three 12-month treatment cycles (Ts).

methodsThis multicenter, prospective, real-world study enrolled 212 patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed three consecutive Ts of subcutaneous anti-CGRP mAbs. Discontinuation periods (D1, D2, D3) were defined as the first month after T1, T2, and T3, respectively. The primary endpoint was the ≥ 50% response rate at D3 compared to D2. Secondary endpoints included changes in monthly migraine days (MMD), monthly headache days (MHD), monthly analgesic intake (MAI), numerical rating scale (NRS), Headache Impact Test-6 (HIT-6), ≥ 50% response rate at D3 versus D1 and D2, and relapse rates to CM or medication overuse.

resultsAt D3 vs. D2, significant improvements (p < 0.001) were observed in the ≥ 50% response rate (77.8% vs. 53.8%), MMD (- 2.1 ± 1.7), MHD (- 2.9 ± 2.4), MAI (- 2.6 ± 2.4), NRS (- 0.7 ± 1.3), and HIT-6 (- 7.2 ± 5.9), with lower relapse rates to CM (2.3% vs. 18%) and medication overuse (1.3% vs. 10.1%). Compared to D1, D3 demonstrated greater benefits (p < 0.001) in MMD (- 2.6 ± 1.9), MHD (- 5.8 ± 3.3), MAI (- 4.9 ± 3.4), NRS (- 1 ± 1.6), and HIT- 6 (- 9.4 ± 7), alongside higher ≥ 50% response rates (77.8% vs. 25%) and reduced relapses to CM (2.3% vs. 67.7%) and medication overuse (1.3% vs. 34.2%). DISCUSSION: Three years of anti-CGRP mAb treatment revealed a progressive increase in the proportion of ≥ 50% responders (D1: 25%; D2: 53.8%; D3: 77.8%) and substantial reductions in migraine burden, suggesting that prolonged treatment may favorably modify migraine course.

Indexed as

Antibodies, MonoclonalMigraine DisordersOutcome Assessment, Health CareAdultFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAntibodies, MonoclonalAnti-CGRP mAbsDiscontinuationDisease modifierMigraineReal worldTreatment

Identifiers

PMID39862304
PMCPMC11762429

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.