Evidence map›Paper›PMID 32747522›Full record

ArticleNeurology2020

Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.

Richard B Lipton, Joshua M Cohen, Sanjay K Gandhi, Ronghua Yang, Paul P Yeung, Dawn C Buse

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02621931 (A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT02621931 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

TypeinterventionalSponsorTeva Branded Pharmaceutical Products R&D, Inc.Ran2016 to 2017Enrolled1,130ConditionsMigraineArmsFremanezumab, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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  13. Predictors of response to galcanezumab in patients with chronic migraine: a real-world prospective observational study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
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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

6 authors at 1 institution in 1 country.

Richard B LiptonFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.
Joshua M CohenFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.
Sanjay K GandhiFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.
Ronghua YangFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.
Paul P YeungFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.
Dawn C BuseFrom the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.
Albert Einstein College of Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).

methodsHALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.

resultsThe full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,

conclusionsFremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM. CLINICALTRIALSGOV IDENTIFIER: NCT02621931. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.

Indexed as

Quality of LifeAdultAntibodies, MonoclonalChronic DiseaseChronic PainDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersSurveys and QuestionnairesVisual Analog ScaleWork PerformanceAntibodies, Monoclonalfremanezumab

Identifiers

PMID32747522
PMCPMC7605497
OpenAlexW3046802458

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.