Evidence map›Paper›PMID 36068494›Full record

Trial reportThe journal of headache and pain2022

Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study.

Robert P Cowan, Michael J Marmura, Hans-Christoph Diener, Amaal J Starling, Jack Schim, Joe Hirman, Thomas Brevig, Roger Cady

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02974153 (A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 27% 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.

NCT02974153 phase3completednot on this map

A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine

TypeinterventionalSponsorAlder Biopharmaceuticals, Inc.Ran2016 to 2018Enrolled1,121ConditionsMigraine DisordersArmsALD403 (Eptinezumab), Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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

8 authors at 7 institutions in 3 countries.

Robert P CowanStanford Health Care, Palo Alto, CA, USA.
Michael J MarmuraJefferson Headache Center, Philadelphia, PA, USA.
Hans-Christoph DienerMedical Faculty of the University Duisburg-Essen, Institute for Medical Informatics, Biometry and Epidemiology, Essen, Germany.
Amaal J StarlingMayo Clinic Arizona, Scottsdale, AZ, USA.
Jack SchimThe Neurology Center of Southern California, Carlsbad, CA, USA.
Joe HirmanPacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.
Thomas BrevigH. Lundbeck A/S, Valby, Denmark.
Roger CadyLundbeck LLC, Deerfield, IL, USA. rcady@rkconsults.com.
Deerfield (United States) · USHeadache Care Center · USLundbeck (Denmark) · DKMayo Clinic in Arizona · USNeurology Center of Southern California · USStanford Health Care · USUniversity of Duisburg-Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with chronic migraine (CM) treated with eptinezumab in the PROMISE-2 trial achieved greater reductions in migraine and headache frequency, impact, and acute headache medication (AHM) use than did patients who received placebo. This post hoc analysis examines relationships between headache frequency reductions and changes in AHM use in patients in PROMISE-2.

methodsPROMISE-2 was a double-blind, placebo-controlled trial conducted in adults with CM. Patients were randomized to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously once every 12 weeks for up to two doses. Patients recorded headache/AHM information daily and for each event in an electronic diary; data from all days with daily reports were included. Shifts in headache frequency and AHM use were assessed in the three populations: total CM population, patients with CM and medication-overuse headache (MOH), and patients with CM and MOH who were ≥ 50% responders during treatment (response over weeks 1-24).

resultsA total of 1072 adults with CM received treatment (eptinezumab, n = 706; placebo, n = 366). Mean baseline headache frequency was 20.5 days; mean baseline AHM days was 13.4; 431 patients had MOH, of which 225 (52.2%) experienced ≥50% response over weeks 1-24. Relative to baseline, the proportion of days with both headache and AHM use decreased 25.1% (eptinezumab) versus 17.0% (placebo) in the total population (N = 1072), 29.2% versus 18.4% in the MOH subpopulation (n = 431), and 38.3% versus 31.5% in the CM with MOH population with ≥50% response subgroup (n = 225) during weeks 1-24. The proportion of days with headache and triptan use decreased 9.1% (eptinezumab) versus 5.8% (placebo), 11.8% versus 7.2%, and 14.5% versus 12.6%, respectively. Reductions in other AHM types were smaller.

conclusionsIn this post hoc analysis, eptinezumab use in patients with CM was associated with greater decreases in days with headache with AHM overall and with triptans in particular. The magnitude of effect was greater in the subgroup of CM patients with MOH and ≥ 50% response.

trial registrationClinicalTrials.gov Identifier: NCT02974153 . Eptinezumab reduces headache frequency and acute medication use in patients with chronic migraine.

Indexed as

Acute PainHeadache Disorders, SecondaryMigraine DisordersAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodHeadacheHumansTreatment OutcomeTryptaminesAntibodies, Monoclonal, HumanizedeptinezumabTryptaminesAnalgesicsChronic migraineEptinezumabMedication-overuse headacheSerotonin 5-HT1 receptor agonists

Identifiers

PMID36068494
PMCPMC9446734
OpenAlexW4294752454

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.