Evidence map›Paper›PMID 36006191›Full record

SynthesisToxins2022

Pooled Analysis of Real-World Evidence Supports Anti-CGRP mAbs and OnabotulinumtoxinA Combined Trial in Chronic Migraine.

Damiana Scuteri, Paolo Tonin, Pierluigi Nicotera, Marilù Vulnera, Giuseppina Cristina Altieri, Assunta Tarsitano, Giacinto Bagetta, Maria Tiziana Corasaniti

Registry-linked trialOpen access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Toxins, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07040813 (A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT07040813 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Placebo-controlled Double-blind Phase III Trial to Investigate the Reduction of Monthly Migraine Days (MMDs) Over 12 Weeks of Treatment With CGRP mAbs and Onabotulinumtoxin A Intramuscularly Compared With CGRP mAbs and Placebo in Chronic Migraine

TypeinterventionalSponsorOslo University HospitalRan2025 to 2029Enrolled450ConditionsMigraine, Chronic Migraine HeadacheArmsCGRP mAbs and onabotulinumtoxin A, CGRP mAbs and placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
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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

8 authors at 4 institutions in 2 countries.

Damiana ScuteriPharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-5846-7058
Paolo ToninRegional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.ORCID 0000-0002-4867-1378
Pierluigi NicoteraGerman Center for Neurodegenerative Diseases (DZNE), 53127 Bonn, Germany.
Marilù VulneraPharmaceutical Service, Provincial Health Authority (ASP), 87100 Cosenza, Italy.
Giuseppina Cristina AltieriPharmaceutical Service, Provincial Health Authority (ASP), 87100 Cosenza, Italy.
Assunta TarsitanoPain Therapy Center, Provincial Health Authority (ASP), 87100 Cosenza, Italy.
Giacinto BagettaPharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.ORCID 0000-0001-8540-6218
Maria Tiziana CorasanitiDepartment of Health Sciences, University "Magna Graecia", 88100 Catanzaro, Italy.ORCID 0000-0001-6472-0697
Istituto S.Anna Crotone · ITGerman Center for Neurodegenerative Diseases · DEMagna Graecia University · ITUniversity of Calabria · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OnabotulinumtoxinA, targeting the CGRP machinery, has been approved for the last two decades for chronic migraine prevention. The recently approved monoclonal antibodies (mAbs) directed towards the calcitonin gene-related peptide (CGRP) pathway open a new age for chronic migraine control. However, some 40% patients suffering from chronic migraine is still resistant to treatment. The aim of this work is to answer the following PICOS (participants intervention comparator outcome study design) question: Is there evidence of efficacy and safety of the combined administration of anti-CGRP mAbs and onabotulinumtoxinA in chronic migraine? A systematic review and meta-analysis [Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 recommendations] was made up to 19 April 2022. The results are encouraging: the combined treatment proved to afford ≥50% monthly headache days (MHDs)/frequency reduction respect to baseline in up to 58.8% of patients; in comparison, anti-CGRP mAbs reduce MHDs of 1.94 days from baseline and botulinum toxin of 1.86 days. Our study demonstrates for the first time that the combination therapy of onabotulinumtoxinA with anti-CGRP mAbs affords a reduction of 2.67 MHDs with respect to onabotulinumtoxinA alone, with moderate certainty of evidence. Adequately powered, good-quality studies are needed to confirm the response to combination therapy in terms of efficacy and safety. PROSPERO registration: CRD42022313640.

Indexed as

Antibodies, MonoclonalBotulinum Toxins, Type AMigraine DisordersCalcitonin Gene-Related PeptideDrug Therapy, CombinationHumansTreatment OutcomeAntibodies, MonoclonalBotulinum Toxins, Type ACalcitonin Gene-Related Peptideanti-CGRP monoclonal antibodiesmigraineonabotulinumtoxinApooled analysisPRISMA 2020

Identifiers

PMID36006191
PMCPMC9413678
OpenAlexW4289526674

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.