Evidence map›Paper›PMID 37468621›Full record

Observational studyJournal of neurology2023

Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study.

Fabrizio Vernieri, Nicoletta Brunelli, Simona Guerzoni, Luigi Francesco Iannone, Carlo Baraldi, Renata Rao, Francesca Schiano di Cola, Raffaele Ornello, Sabina Cevoli, Carlo Lovati and 9 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
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

19 authors.

Fabrizio VernieriUnità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy. f.vernieri@policlinicocampus.it.ORCID http://orcid.org/0000-0002-9594-9336
Nicoletta BrunelliUnità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Simona GuerzoniDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology, Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico di Modena, Modena, Italy.
Luigi Francesco IannoneHeadache Center, Section of Clinical Pharmacology and Oncology, Department of Health Sciences, Careggi University Hospital, University of Florence, Florence, Italy.
Carlo BaraldiDigital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology, Headache Center and Drug Abuse, Laboratory of Clinical Pharmacology and Pharmacogenomics, Department of Specialist Medicines, AOU Policlinico di Modena, Modena, Italy.
Renata RaoHeadache Center, ASST Spedali Civili of Brescia, Department Continuity of Care and Fragility, Department of Clinical and Experimental Sciences, Neurological Clinic, University of Brescia, Brescia, Italy.
Francesca Schiano di ColaHeadache Center, ASST Spedali Civili of Brescia, Department Continuity of Care and Fragility, Department of Clinical and Experimental Sciences, Neurological Clinic, University of Brescia, Brescia, Italy.
Raffaele OrnelloDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Sabina CevoliIRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
Carlo LovatiHeadache Center, Neurology Unit, L. Sacco University Hospital, Milan, Italy.
Maria AlbaneseNeurology Unit, Headache Center, Tor Vergata University Hospital, Rome, Italy.
Armando PerrottaIRCCS Neuromed, Pozzilli, Isernia, Italy.
Ilaria CettaNeuroimaging Research Unit, Division of Neuroscience; Neurology Unit and Neurophysiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Sergio Soeren RossiNeurologia, Dipartimento di Medicina e Chirurgia, Università Campus Bio-Medico di Roma, Rome, Italy.
Valentina TarantaDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Massimo FilippiNeuroimaging Research Unit, Division of Neuroscience; Neurology Unit and Neurophysiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Pierangelo GeppettiHeadache Center, Section of Clinical Pharmacology and Oncology, Department of Health Sciences, Careggi University Hospital, University of Florence, Florence, Italy.
Simona SaccoDepartment of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Claudia AltamuraUnità Cefalee e Neurosonologia, Fondazione Policlinico Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe outcome of migraine patients retreated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (anti-CGRP) or its receptor (anti-CGRPr) is not completely known.

methodsThis multicentric prospective observational cohort study assessed monthly migraine days (MMDs), migraine acute medication intake (MAMI), and HIT-6 at baseline, after 90-112 days (Rev-1), after 84-90 days since Rev-1 (Rev-2) and 30 days after the last injection of anti-CGRP/CGRPr mAbs (Year-end), in the first and the second year after a discontinuation period.

resultsWe enrolled 226 patients (79.6% with chronic migraine; 55.3% on erenumab and 44.7% on galcanezumab or fremanezumab). MMDs, MAMI, and HIT-6-did not differ at the respective first and second-year evaluations in the entire cohort, and comparing anti-CGRP with anti-CGRPr Abs. MMDs (18.1 ± 7.8 vs. 3.4 ± 7.8), MAMI (26.7 ± 28.3 vs.17.7 ± 17.2), and HIT-6 scores (63.1 ± 5.9 vs. 67.1 ± 10.3) were lower in the second year than in the pre-treatment baseline (consistently, p < 0.0001). Second-year baseline MMDs were lower in patients on anti-CGRP mAbs (p = 0.001) and with lower pre-treatment baseline MMDs (p ≤ 0.001).

conclusionAnti-CGRP/CGRPr mAbs are effective in the second as in the first year. The use of anti-CGRP or CGRPr mAbs influenced the second-year baseline MMDs, but their effectiveness did not differ during the two treatment years.

Indexed as

Antibodies, MonoclonalCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistsMigraine DisordersAdultAntibodies, Monoclonal, HumanizedCohort StudiesFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideCalcitonin Gene-Related Peptide Receptor AntagonistserenumabfremanezumabgalcanezumabCGRPDiscontinuationMigraineMonoclonal antibodiesReal lifeRetreatment

Identifiers

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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.