Evidence map›Paper›PMID 38583127›Full record

ArticleCNS drugs2024

Synergism of Anti-CGRP Monoclonal Antibodies and OnabotulinumtoxinA in the Treatment of Chronic Migraine: A Real-World Retrospective Chart Review.

Amira Salim, Elise Hennessy, Claire Sonneborn, Olivia Hogue, Sudipa Biswas, MaryAnn Mays, Aarushi Suneja, Zubair Ahmed, Ignacio F Mata

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in CNS drugs, 2024. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Observational
  2. Article
  3. Observational
  4. Article
  5. Review
  6. 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

9 authors at 2 institutions in 1 country.

Amira Salim *Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA.ORCID 0000-0001-5300-3983
Elise Hennessy *Neuroscience Institute, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
Claire SonnebornQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Olivia HogueQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-3985-3831
Sudipa BiswasQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
MaryAnn MaysQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Aarushi SunejaQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Zubair AhmedQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
Ignacio F MataGenomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. matai@ccf.org.ORCID 0000-0003-1198-0633
Cleveland Clinic Lerner College of Medicine · USPenn State Milton S. Hershey Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with chronic migraine do not achieve clinically meaningful improvement in their headache frequency with monotherapy. The burden associated with chronic migraine calls for a multifaceted treatment approach targeting multiple aspects of migraine pathophysiology.

objectiveThe aim of this study was to evaluate the effect of concurrent anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) and onabotulinumtoxinA (onabot) treatment on median monthly migraine days (MMD) in patients with chronic migraine, through a retrospective study.

methodsThe electronic medical records of Cleveland Clinic patients either concurrently (dual therapy) or consecutively (monotherapy) treated with anti-CGRP mAbs and onabot between June 2018 and November 2021 were extracted. Only adult patients (≥ 18 years of age) were included in this study. MMDs for 194 concurrently treated (86.6% female and a median [interquartile range] age of 51 [41-61] years) and 229 consecutively treated (88.2% female and median age of 47 [IQR 39-57] years) patients were examined at baseline, after first therapy of either anti-CGRP mAb or onabot, and following dual therapy for 3 consecutive months. The reduction of MMDs for each treatment group were compared. The same approach was utilized to compare consecutive monotherapy at separate times (n = 229) and dual-therapy groups.

resultsThe initial treatment of the dual-therapy group reduced the median (IQR) MMDs from 30 (30-30) to 15 (12-30) [p < 0.0001]. After initiation of dual therapy, the median MMDs was further decreased from 15 (12-30) to 8 (3-22) [p < 0.0001]. A majority [132/194 (68.0%)] of the dual-therapy patients reported a ≥ 50% reduction in MMD and 90/194 (46.4%) reported a ≥ 75% reduction. For the consecutive monotherapy group, median MMDs changed from a baseline of 30 (25-30) to 15 (8-25) from onabot monotherapy and decreased from 25 (15-30) to 12 (4-25) after anti-CGRP mAb monotherapy. Almost half (113/229 [49.3%] from onabot, and 104/229 [45.4%] from anti-CGRP mAb) of these patients achieved a ≥ 50% reduction in MMDs and a minority (38/229 [16.6%] from onabot, and 45/229 [19.7%] from anti-CGRP mAb) achieved a reduction of ≥ 75%. Additionally, dual therapy showed significant improvement in MMDs compared with monotherapy of either treatment (p < 0.0001).

conclusionDual therapy of anti-CGRP mAbs and onabot may be more efficacious than monotherapy, possibly due to their synergistic mechanisms of action.

Indexed as

Botulinum Toxins, Type ACalcitonin Gene-Related PeptideMigraine DisordersAdultAntibodies, MonoclonalChronic DiseaseDrug SynergismDrug Therapy, CombinationFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAntibodies, MonoclonalBotulinum Toxins, Type ACalcitonin Gene-Related Peptideonabotulinum toxin A

Identifiers

PMID38583127
PMCPMC11098928
OpenAlexW4394063733

What OpenQuestion holds

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LicenceCC BY-NC
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.