Evidence map›Paper›PMID 34922444›Full record

Observational studyThe journal of headache and pain2021

Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study.

Fabrizio Vernieri, Nicoletta Brunelli, Roberta Messina, Carmelina Maria Costa, Bruno Colombo, Paola Torelli, Simone Quintana, Sabina Cevoli, Valentina Favoni, Florindo d'Onofrio and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05442008 (Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine), which is not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
8.4field-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.

NCT05442008 completednot on this map

Study of Early MIDAS Reduction at 3 Months as Predictor of Long-term Erenumab Treatment in Chronic Migraine: a Real-life, Open-label, Trial

TypeobservationalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2018 to 2021Enrolled53ConditionsMigraineArmsErenumab 70/140 mg s.c.
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 5 syntheses or guidelines pooled it, 66 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

15 authors at 8 institutions in 1 country.

Fabrizio VernieriHeadache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy. f.vernieri@unicampus.it.ORCID http://orcid.org/0000-0002-9594-9336
Nicoletta BrunelliHeadache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Roberta MessinaNeurology, Neurorehabilitation and Neurophysiology Units, IRCCS Ospedale San Raffaele and University 'Vita e Salute', Milan, Italy.
Carmelina Maria CostaHeadache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Bruno ColomboNeurology, Neurorehabilitation and Neurophysiology Units, IRCCS Ospedale San Raffaele and University 'Vita e Salute', Milan, Italy.
Paola TorelliDepartment of Medicine and Surgery, Parma and Neurology Unit, AOU di Parma, University of Parma, Parma, Italy.
Simone QuintanaDepartment of Medicine and Surgery, Parma and Neurology Unit, AOU di Parma, University of Parma, Parma, Italy.
Sabina CevoliIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Valentina FavoniIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Florindo d'OnofrioNeurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy.
Gabriella EgeoHeadache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
Renata RaoNeurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Massimo FilippiNeurology, Neurorehabilitation and Neurophysiology Units, IRCCS Ospedale San Raffaele and University 'Vita e Salute', Milan, Italy.
Piero Barbanti *Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy.
Claudia Altamura *Headache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Università Campus Bio-Medico · ITIRCCS Ospedale San Raffaele · ITIstituto delle Scienze Neurologiche di Bologna · ITUniversity of Parma · ITAzienda Ospedaliera S.Giuseppe Moscati · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITSan Raffaele University of Rome · ITUniversity of Brescia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway are effective and safe on migraine prevention. However, some drug agencies limited these treatments to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in high-frequency episodic (HFEM) and chronic migraine (CM) patients.

methodsThis observational longitudinal cohort study was conducted at 10 Italian headache centres. Consecutive adult patients were followed-up for three months (F-UP1-3) after discontinuation of a one-year erenumab/galcanezumab treatment. The primary endpoint was the change in F-UP MMDs. Secondary endpoints included variation in pain intensity (Numerical Rating Scale, NRS), monthly acute medication intake (MAMI), and HIT-6 scores. We also assessed from F-UP1 to 3 the ≥50% response rate, relapse rate to CM, and recurrence of Medication Overuse (MO).

resultsWe enrolled 154 patients (72.1% female, 48.2 ± 11.1 years, 107 CM, 47 HFEM); 91 were treated with erenumab, 63 with galcanezumab. From F-UP1 to F-UP3, MMDs, MAMI, NRS, and HIT-6 progressively increased but were still lower at F-UP3 than baseline (Friedman's analysis of rank, p < .001). In the F-UP1-3 visits, ≥50% response rate frequency did not differ significantly between CM and HFEM patients. However, the median reduction in response rate at F-UP3 was higher in HFEM (- 47.7% [25th, - 79.5; 75th,-17.0]) than in CM patients (- 25.5% [25th, - 47.1; 75th, - 3.3]; Mann-Whitney U test; p = .032). Of the 84 baseline CM patients who had reverted to episodic migraine, 28 (33.3%) relapsed to CM at F-UP1, 35 (41.7%) at F-UP2, 39 (46.4%) at F-UP3. Of the 64 baseline patients suffering of medication overuse headache ceasing MO, 15 (18.3%) relapsed to MO at F-UP1, 26 (31.6%) at F-UP2, and 30 (42.3%, 11 missing data) at F-UP3. Lower MMDs, MAMI, NRS, and HIT-6 and higher response rate in the last month of therapy characterized patients with ≥50% response rate at F-UP1 and F-UP3 (Mann-Whitney U test; consistently p < .01).

conclusionMigraine frequency and disability gradually increased after mAbs anti-CGRP interruption. Most patients did not relapse to MO or CM despite the increase in MMDs. Our data suggest to reconsider mAbs anti-CGRP discontinuation.

Indexed as

Antibodies, MonoclonalHeadache Disorders, SecondaryMigraine DisordersAdultCalcitonin Gene-Related PeptideFemaleHumansItalyLongitudinal StudiesMaleMiddle AgedAntibodies, MonoclonalCalcitonin Gene-Related PeptideCalcitonin gene-related peptideDiscontinuationMigraine treatmentMonoclonal antibodiesReal-world

Identifiers

PMID34922444
PMCPMC8903705
OpenAlexW4226295842

What OpenQuestion holds

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Registered trials

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.