Evidence map›Paper›PMID 31710104›Full record

Trial reportHeadache2020

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies.

Holland C Detke, Brian A Millen, Qi Zhang, Karen Samaan, Jessica Ailani, David W Dodick, Sheena K Aurora

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 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

27 citing papers in PubMed, 3 syntheses or guidelines 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

7 authors.

Holland C DetkeEli Lilly and Company, Indianapolis, IN, USA.
Brian A MillenEli Lilly and Company, Indianapolis, IN, USA.
Qi ZhangEli Lilly and Company, Indianapolis, IN, USA.
Karen SamaanEli Lilly and Company, Indianapolis, IN, USA.
Jessica AilaniMedStar Georgetown University, Washington, DC, USA.
David W DodickDepartment of Neurology, Mayo Clinic, Phoenix, AZ, USA.
Sheena K AuroraEli Lilly and Company, Indianapolis, IN, USA.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

objectiveTo evaluate onset of effect of galcanezumab in patients with episodic migraine.

backgroundGalcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. DESIGN/

methodsData on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs.

resultsFor both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P < .001) and each subsequent week compared with placebo-treated patients (P ≤ .004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P < .001], and for EVOLVE-2, 59.4% vs 38.0% [P < .001]).

conclusionRapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.

Indexed as

Outcome Assessment, Health CareAdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related PeptideDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedMigraine DisordersAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptidegalcanezumabcalcitonin gene-related peptideepisodic migrainegalcanezumabonset of effect

Identifiers

PMID31710104
PMCPMC7028148

What OpenQuestion holds

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LicenceCC BY-NC
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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.