Evidence map›Paper›PMID 40332560›Full record

Observational studyJournal of neurology2025

A 24-week prospective, multicenter, real-world study on eptinezumab's effectiveness and safety in migraine prevention (EMBRACE II).

Piero Barbanti, Cinzia Aurilia, Gabriella Egeo, Alberto Doretti, Florindo d'Onofrio, Paola Scatena, Steno Rinalduzzi, Luisa Vinciguerra, Mattia Sansone, Rosario Vecchio and 32 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study 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 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Observational
  7. Article
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

42 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.
Gabriella EgeoHeadache and Pain Unit, IRCCS San Raffaele Roma, Via della Pisana 235, 00163, Rome, Italy.
Alberto DorettiLaboratory of Neurosciences, Department of Neurology-Stroke Unit, Istituto Auxologico Italiano, IRCCS, Milano, Italy.
Florindo d'OnofrioStroke Unit and Headache Center Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy.
Paola ScatenaDepartment of Neurology and Stroke Unit, San Camillo de Lellis, General District Hospital, Rieti, Italy.
Steno RinalduzziDepartment of Neurology and Stroke Unit, San Camillo de Lellis, General District Hospital, Rieti, Italy.
Luisa VinciguerraDepartment of Neurology, ASST Crema Hospital, Crema, Italy.
Mattia SansoneHeadache Center, San Giuseppe Moscati Hospital, Aversa, Italy.
Rosario VecchioNeurology Unit Muscatello Hospital Augusta ASP, Siracusa, Italy.
Valeria DragoNeurology Unit Muscatello Hospital Augusta ASP, Siracusa, Italy.
Giovanna ViticchiNeurological Clinic, Marche Polytechnic University, Ancona, Italy.
Marco BartoliniNeurological Clinic, Marche Polytechnic University, Ancona, Italy.
Angelo RanieriHeadache Centre, Division of Neurology and Stroke-Unit, Antonio Cardarelli Hospital, Naples, Italy.
Monica Bandettini di PoggioIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Francesco BaldisseriIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Davide MascarellaIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.
Fabio BrusaferriDepartment of Neurology, ASST Crema Hospital, Crema, Italy.
Luigi CaputiDepartment of Neurology, ASST Crema Hospital, Crema, Italy.
Stefano MessinaLaboratory of Neurosciences, Department of Neurology-Stroke Unit, Istituto Auxologico Italiano, IRCCS, Milano, Italy.
Massimo AutunnoDepartment of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Alessandro ValenzaDepartment of Neuroscience, O.U. of Neurology, Headache Center, Stroke Unit, Belcolle Hospital, Viterbo, Italy.
Bianca OrlandoHeadache and Pain Unit, IRCCS San Raffaele Roma, Via della Pisana 235, 00163, Rome, Italy.
Marisa DistefanoDepartment of Neuroscience, O.U. of Neurology, Headache Center, Stroke Unit, Belcolle Hospital, Viterbo, Italy.
Laura BorrelloHeadache Center, Francesco Spaziani Hospital, Frosinone, Italy.
Francesca PistoiaDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Cecilia CamardaDepartment of Biomedicine, Neurosciences, and Advanced Diagnostics, University of Palermo, Palermo, Italy.
Gennaro SaporitoDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Giacomo QuerzolaStroke Unit, Neurology Division, and Headache Center, San Carlo Borromeo Hospital, ASST Santi Paolo e Carlo, Milan, Italy.
Paola TorelliUnit of Neurology, Department of Medicine and Surgery, Headache Center, University of Parma, Parma, Italy.
Antonio SalernoHeadache Center, San Giovanni Addolorata Hospital, Rome, Italy.
Francesca GragnaniHeadache Center, Sandro Pertini Hospital, Rome, Italy.
Barbara PetolicchioHeadache Center, Sandro Pertini Hospital, Rome, Italy.
Antonio CarnevaleHeadache Center, San Filippo Neri Hospital, Rome, Italy.
Roberta MessinaDepartment of Neurology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Massimo FilippiDepartment of Neurology, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Sofia TavaniCatholic University of Sacred Heart Rome, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy.
Giulia FiorentiniHeadache and Pain Unit, IRCCS San Raffaele Roma, Via della Pisana 235, 00163, Rome, Italy.
Stefano BonassiDepartment for the Promotion of Human Sciences and Quality of Life, University San Raffaele, Rome, Italy.
Sabina Cevoli *IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.
Alice Mannocci *Department for the Promotion of Human Sciences and Quality of Life, University San Raffaele, Rome, Italy.
Italian Migraine Registry (I-GRAINE) study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe evaluated the effectiveness, tolerability, and safety of eptinezumab in preventing high-frequency episodic migraine (HFEM) and chronic migraine (CM) over 24 weeks in real-world. We also assessed its impact during the first treatment week, in patients failing monoclonal antibodies targeting the calcitonin gene-related peptide (anti-CGRP mAbs), and the effects of dose escalation to 300 mg in patients requiring enhanced control.

methodsEMBRACE II is a multicenter (n = 22), prospective, 24-week, real-world study involving consecutive patients with HFEM or CM who had failed > 3 preventive treatments. Eptinezumab (100 mg, with the option for escalation to 300 mg at week 12) was administered quarterly. PRIMARY ENDPOINT: change in monthly migraine days (MMD), for HFEM or monthly headache days (MHD), for CM, between weeks 21-24 and baseline. Secondary endpoints: changes in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), Migraine Disability Assessment Scale (MIDAS), Migraine Interictal Burden Scale (MIBS-4), and responder rates.

resultsOf the 215 participants who had received ≥ 1 eptinezumab dose, 74 were treated for ≥ 24 weeks and considered for effectiveness analysis. Eptinezumab significantly (p < 0.001) reduced MMD/MHD (- 10.5), MAI (- 15.6), NRS (- 2.2), HIT-6 (- 9.9), MIDAS (- 48.7), and MIBS-4 (- 4.3). ≥ 50% responders were 69%, ≥ 75% responders 39.2%, and 100% responders 4.1%. Comparing the first week with the last baseline week, a significant reduction in migraine days was observed (- 3.7; p < 0.001). Significant improvements were seen in patients failing anti-CGRP mAbs (32.4%) and in those escalating to 300 mg (33.8%). Half of the subjects reported being "very much improved" or "much improved". The adverse events were infrequent (2.8%).

conclusionsThis real-world study documents that 24-week eptinezumab treatment is rapidly effective and well tolerated in migraine patients with multiple therapeutic failures (including anti-CGRP mAbs). One-third of patients escalated to 300 mg at week 12, achieving further significant migraine-related disability reduction.

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedeptinezumabCGRPDisabilityEptinezumabMigraineReal-worldTreatment

Identifiers

PMID40332560
PMCPMC12058817

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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.