Evidence map›Paper›PMID 34592919›Full record

ArticleThe journal of headache and pain2021

Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study.

Rose Okonkwo, Antje Tockhorn-Heidenreich, Chad Stroud, Marie-Ange Paget, Manjit S Matharu, Cristina Tassorelli

Registry-linked trialAbstract read
In one paragraph

Article 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 NCT03559257 (A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT03559257 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2019Enrolled463ConditionsMigraineArmsGalcanezumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Observational
  2. 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

6 authors.

Rose OkonkwoEli Lilly and Company, Medical Affairs CRS, Indianapolis, IN, 46285, USA. okonkwo_rose@lilly.com.
Antje Tockhorn-HeidenreichEli Lilly and Company, Medical Affairs CRS, Indianapolis, IN, 46285, USA.
Chad StroudEli Lilly and Company, Medical Affairs CRS, Indianapolis, IN, 46285, USA.
Marie-Ange PagetEli Lilly and Company, Medical Affairs CRS, Indianapolis, IN, 46285, USA.
Manjit S MatharuUniversity College London (UCL) Queen Square Institute of Neurology and National Hospital for Neurology and Neurosurgery, London, UK.
Cristina TassorelliHeadache Science and Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic migraine (CM) and episodic migraine (EM) are associated with substantial headache-related disability, poor quality of life and global societal burden. In this subgroup analysis from the CONQUER study, we report efficacy outcomes from a pre-specified analysis of galcanezumab versus placebo in patients with CM or EM and 3-4 prior preventive medication category failures due to inadequate efficacy (after at least 2 months at maximum tolerated dose), or safety or tolerability reasons. The patient population is of particular interest due to evidence of decreased quality of life and increased economic burden among patients with migraine that is inadequately managed and is of interest to decision-makers globally.

methodsKey outcomes included overall mean change from baseline in monthly migraine headache days and proportions of patients achieving ≥30% (CM), ≥50%, and ≥ 75% reduction (response rates) in monthly migraine headache days across Months 1-3. Patient functioning and disability were evaluated at Month 3.

resultsOf the 462 randomized patients, 186 (40.3%) had a history of 3-4 preventive category failures. Galcanezumab versus placebo resulted in significantly (P ≤ .001) larger overall mean reduction in monthly migraine headache days (total: - 5.49 versus - 1.03; CM: - 6.70 versus - 1.56; EM: - 3.64 versus - 0.65). Similarly, the ≥50% response rate was significantly (P ≤ .001) higher with galcanezumab versus placebo (total: 41.0 versus 12.7; CM: 41.5 versus 8.4; EM: 41.1 versus 16.5). In the CM group, the ≥30% response rate was significantly higher in the galcanezumab group than the placebo group (CM, 57.5 versus 19.8, P ≤ .0001) as was the ≥75% response rate (13.3 versus 2.6, P ≤ .05). Galcanezumab also resulted in significant (P < .0001) improvements in patient functioning and reductions in disability.

conclusionsGalcanezumab was effective in a difficult-to-treat population of patients with CM or EM who had failed 3-4 prior preventive medication categories.

trial registrationCONQUER. Clinicaltrials.gov identifier: NCT03559257 .

Indexed as

Migraine DisordersQuality of LifeAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedgalcanezumabCalcitonin gene-related peptideCGRPDifficult-to-treatMigraine headache daysPrior preventive

Identifiers

PMID34592919
PMCPMC8482748

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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.