Evidence map›Paper›PMID 35804294›Full record

Trial reportBMC neurology2022

Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab.

Andrew Blumenfeld, Anders Ettrup, Joe Hirman, Bjarke Ebert, Roger Cady

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in BMC neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02985398 (An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT02985398 phase3completednot on this map

An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines

TypeinterventionalSponsorAlder Biopharmaceuticals, Inc.Ran2016 to 2019Enrolled128ConditionsMigraine DisorderArmsALD403 (Eptinezumab)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 15 citations in OpenAlex.

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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

5 authors at 3 institutions in 2 countries.

Andrew BlumenfeldThe Los Angeles Headache Center, Los Angeles, CA, USA.
Anders EttrupH. Lundbeck A/S, Copenhagen, Denmark.
Joe HirmanPacific Northwest Statistical Consulting, Woodinville, WA, USA.
Bjarke EbertH. Lundbeck A/S, Copenhagen, Denmark.
Roger CadyLundbeck LLC, Deerfield, IL, USA. rcady@rkconsults.com.
Lundbeck (Denmark) · DKLundbeck (United States) · USPain and Headache Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEptinezumab is an anti-calcitonin gene-related peptide humanized monoclonal antibody approved for the preventive treatment of migraine in adults. The PREVAIL study demonstrated a favorable safety profile with sustained reductions in overall migraine-related burden in patients with chronic migraine (CM). This post hoc analysis aimed to examine item-level changes in the Migraine Disability Assessment (MIDAS) questionnaire over 2 years in participants with CM on eptinezumab treatment.

methodsPREVAIL was an open-label, phase 3 trial that included 96 weeks of treatment where 128 adults received intravenous eptinezumab administered over 30 min every 12 weeks (wks) for up to 8 doses of 300 mg. MIDAS was administered at baseline, Wk12, and every 12wks thereafter. Two supplementary MIDAS items not included in the total score calculation assessed number of headache days in the past 3 months (MIDAS headache) and average headache pain severity (from 0 [none] to 10 [worst]). MIDAS total scores were summed from 5 items, each quantifying the number of days in the past 3 months with migraine-related disability. Items 1, 3, and 5 assessed absenteeism, namely how many days the patient missed work/school (Q1), household work (Q3), or family/social/leisure activities (Q5). Items 2 and 4 were measures of presenteeism, namely how many days the patient had reduced productivity in work/school (Q2) or household work (Q4).

resultsMean MIDAS headache days decreased from 47.4 (baseline) to 17.1 (Wk12) and 16.3 (Wk104). The average headache pain severity score (0‒10) decreased from a mean of 7.3 (baseline) to 5.5 (Wk12) to 4.5 (Wk104). Mean MIDAS scores measuring absenteeism (Q1, 3, 5) changed from 9.7 days at baseline to 3.2 days (Wk12) and to 3.9 days (Wk104). Mean MIDAS scores measuring presenteeism (Q2, 4) at Wk12 decreased from 14.2 days at baseline to 5.2 days (Wk12, 104). Patients categorized with very severe MIDAS disability had a mean total MIDAS score of 84.8, with an average reduction of 56.7 days (Wk12), which was maintained at 32 days at Wk104.

conclusionsLong-term treatment with eptinezumab in patients with CM suggested sustained reductions in MIDAS-quantified disability, consistent with the sustained reductions in headache frequency and pain severity.

trial registrationClinicalTrials.gov identifier: NCT02985398 .

Indexed as

Migraine DisordersAdultAntibodies, Monoclonal, HumanizedChronic DiseaseDisability EvaluationDouble-Blind MethodHeadacheHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedeptinezumabCGRP monoclonal antibodyChronic migraineEptinezumabPatient-reported outcomes

Identifiers

PMID35804294
PMCPMC9264513
OpenAlexW4284898968

What OpenQuestion holds

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LicenceCC BY
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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.