Evidence map›Paper›PMID 38549121›Full record

ArticleThe journal of headache and pain2024

Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab.

Linus Jönsson, Susanne F Awad, Stephane A Regnier, Brian Talon, Steven Kymes, Xin Ying Lee, Peter J Goadsby

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in The journal of headache and pain, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04418765 (Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments), 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
0.8field-weighted citation impact, top 30% 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.

NCT04418765 phase3completednot on this map

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

TypeinterventionalSponsorH. Lundbeck A/SRan2020 to 2022Enrolled892ConditionsMigraineArmsEptinezumab, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Structural equation modeling of findings in pediatric tele-neuroradiology: a 2-year nationwide study of turnaround time predictors and clinical decision support.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026
    Article
  4. A Model for the Development of Alzheimer's Disease.Genomics, proteomics & bioinformatics · 2025
    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

7 authors at 4 institutions in 4 countries.

Linus JönssonDepartment for Neurobiology, Care Sciences and Society, Division of Neurogeriatrics, Karolinska Institutet, Solna, Sweden.
Susanne F AwadH. Lundbeck A/S, Copenhagen, Denmark.
Stephane A RegnierLundbeck LLC, Deerfield, IL, USA.
Brian TalonLundbeck LLC, Deerfield, IL, USA.
Steven KymesLundbeck LLC, Deerfield, IL, USA.
Xin Ying LeeH. Lundbeck A/S, Copenhagen, Denmark. XILE@lundbeck.com.
Peter J GoadsbyNIHR King's Clinical Research Facility and Headache Group, King's College London, London, UK.
Lundbeck (United States) · USLundbeck (Denmark) · DKKarolinska Institutet · SEKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs new migraine therapies emerge, it is crucial for measures to capture the complexities of health-related quality of life (HRQoL) improvement beyond improvements in monthly migraine day (MMD) reduction. Investigations into the correlations between MMD reduction, symptom management, and HRQoL are lacking, particularly those that focus on improvements in canonical symptoms and improvement in patient-identified most-bothersome symptoms (PI-MBS), in patients treated with eptinezumab. This exploratory analysis identified efficacy measures mediating the effect of eptinezumab on HRQoL improvements in patients with migraine.

methodsData from the DELIVER study of patients with 2-4 prior preventive migraine treatment failures (NCT04418765) were inputted to two structural equation models describing sources of HRQoL improvement via Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores. A single latent variable was defined to represent HRQoL and describe the sources of HRQoL in DELIVER. One model included all migraine symptoms while the second model included the PI-MBS as the only migraine symptom. Mediating variables capturing different aspects of efficacy included MMDs, other canonical symptoms, and PI-MBS.

resultsIn the first model, reductions in MMDs and other canonical symptoms accounted for 35% (standardized effect size [SES] - 0.11) and 25% (SES - 0.08) of HRQoL improvement, respectively, with 41% (SES - 0.13) of improvement comprising "direct treatment effect," i.e., unexplained by mediators. In the second model, substantial HRQoL improvement with eptinezumab (86%; SES - 0.26) is due to MMD reduction (17%; SES - 0.05) and change in PI-MBS (69%; SES - 0.21).

conclusionsImprovements in HRQoL experienced by patients treated with eptinezumab can be substantially explained by its effect on migraine frequency and PI-MBS. Therefore, in addition to MMD reduction, healthcare providers should discuss PI-MBS improvements, since this may impact HRQoL. Health technology policymakers should consider implications of these findings in economic evaluation, as they point to alternative measurement of quality-adjusted life years to capture fully treatment benefits in cost-utility analyses.

trial registrationClinicalTrials.gov (Identifier: NCT04418765 ; EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25 ).

Indexed as

Antibodies, Monoclonal, HumanizedMigraine DisordersQuality of LifeClinical Trials as TopicHumansLatent Class AnalysisTreatment OutcomeAntibodies, Monoclonal, HumanizedeptinezumabEptinezumabMigraineStructural equation modelingTreatment efficacy

Identifiers

PMID38549121
PMCPMC10976712
OpenAlexW4393260423

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.