Evidence map›Paper›PMID 36097739›Full record

ArticleEuropean journal of neurology2023

Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study.

Fabrizio Vernieri, Nicoletta Brunelli, Marilena Marcosano, Cinzia Aurilia, Gabriella Egeo, Carlo Lovati, Valentina Favoni, Armando Perrotta, Ilaria Maestrini, Renata Rao and 11 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in European journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
10.4field-weighted citation impact, top 1% of its field
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

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 69 citations in OpenAlex.

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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

21 authors at 13 institutions in 1 country.

Fabrizio VernieriHeadache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.ORCID 0000-0002-9594-9336
Nicoletta BrunelliHeadache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.
Marilena MarcosanoHeadache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.
Cinzia AuriliaHeadache and Pain Unit, IRCCS San Raffaele Pisana, Rome, Italy.
Gabriella EgeoHeadache and Pain Unit, IRCCS San Raffaele Pisana, Rome, Italy.
Carlo LovatiNeurology Unit, Headache Center, University Hospital L. Sacco, Milan, Italy.
Valentina FavoniIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID 0000-0001-5335-2438
Armando PerrottaIRCCS NEUROMED, Pozzilli, Isernia, Italy.
Ilaria MaestriniDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Renata RaoNeurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Luigi d'OnofrioHeadache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.
Cinzia FinocchiIRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Marco AguggiaNeurology and Stroke Unit, Asti Hospital, Asti, Italy.
Francesco BonoNeurology Unit, Center for Headache and Intracranial Pressure Disorders, A.O.U. Mater Domini, Catanzaro, Italy.ORCID 0000-0002-4650-6635
Angelo RanieriNeurology and Stroke Unit, AORN A. Cardarelli, Naples, Italy.
Maria AlbaneseNeurology Unit, Headache Center, Tor Vergata University Hospital, Rome, Italy.ORCID 0000-0002-5113-2017
Vittorio Di PieroDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.ORCID 0000-0002-2631-7562
Sabina CevoliIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Claudia AltamuraHeadache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.ORCID 0000-0002-5934-5535
Piero BarbantiHeadache and Pain Unit, IRCCS San Raffaele Pisana, Rome, Italy.ORCID 0000-0002-5670-3755
GARLIT Study Group
Campus Bio Medico University Hospital · ITIRCCS Ospedale San Raffaele · ITIstituto delle Scienze Neurologiche di Bologna · ITSapienza University of Rome · ITAzienda Ospedaliero Universitario Mater Domini · ITAzienda Sanitaria Locale di Asti · ITIstituto Neurologico Mediterraneo · ITLuigi Sacco Hospital · ITOspedale Antonio Cardarelli · ITOspedale Policlinico San Martino · ITSan Raffaele University of Rome · ITUniversity of Brescia · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeTo evaluate the 1-year effectiveness and tolerability of galcanezumab in real life and the prognostic indicators of persistent response.

methodsHigh-frequency episodic migraine (HFEM) and chronic migraine (CM) patients treated with galcanezumab who completed a 1-year observation were enrolled. The primary outcomes assessed during the 12 months (V1-V12) were the change in monthly migraine days (MMDs) from baseline and the response rates ≥50% in MMDs (MMD ≥50% RR). The secondary outcomes were changes in pain intensity (numerical rating scale [NRS]) and in monthly acute medication intake (MAMI).

resultsWe enrolled 191 patients (77.5% CM). Twenty-three patients (12%) dropped out, two for nonserious adverse events. At least 40% of patients took add-on standard preventives from baseline to V12. At V12, MMDs were reduced by 6.0 days in HFEM and by 11.9 days in CM patients (both p < 0.00001); NRS and MAMI were also decreased in both groups (p < 0.00001). One-hundred eight (56.5%) patients presented MMD ≥50% RR for 9 cumulative months (interquartile range=8): we defined this value as the cutoff for a persistent response. Persistent responders were less likely to have a higher body mass index (BMI) (p = 0.007) but more frequently had a good response to triptans (p = 0.005) and MMD ≥50% RR at V1 (p < 0.0000001). Patients without a persistent response were on add-on therapy for longer periods of time (p < 0.001).

conclusionsGalcanezumab was effective and well-tolerated in the 1-year term, with most patients presenting MMD ≥50% RR for at least 9 months. Triptan response, lower BMI, and MMD ≥50% RR in the first month emerged as predictive factors for a persistent response.

Indexed as

Migraine DisordersAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansProspective StudiesTreatment OutcomeTryptaminesAntibodies, Monoclonal, HumanizedgalcanezumabTryptaminesCGRPgalcanezumabmigrainemonoclonal antibodiesreal life

Identifiers

PMID36097739
PMCPMC10086852
OpenAlexW4295517433

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.