Evidence map›Paper›PMID 34455556›Full record

Trial reportAdvances in therapy2021

Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant.

Karissa M Johnston, Gilbert L'Italien, Evan Popoff, Lauren Powell, Robert Croop, Alexandra Thiry, Linda Harris, Vladimir Coric, Richard B Lipton

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03266588 (A Multicenter, Open Label Long-Term Safety Study of BHV-3000 in the Acute Treatment of Migraine), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 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.

NCT03266588 phase2 / phase3completednot on this map

A Multicenter, Open Label Long-Term Safety Study of BHV-3000 in the Acute Treatment of Migraine

TypeinterventionalSponsorPfizerRan2017 to 2019Enrolled3,019ConditionsMigraine, With or Without AuraArmsRimegepant
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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

9 authors.

Karissa M JohnstonBroadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada. kjohnston@broadstreetheor.com.ORCID http://orcid.org/0000-0003-4570-9972
Gilbert L'ItalienBiohaven Pharmaceuticals, New Haven, CT, USA.
Evan PopoffBroadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada.
Lauren PowellBroadstreet Health Economics and Outcomes Research, 203-343 Railway St., Vancouver, BC, V6A 1A4, Canada.
Robert CroopBiohaven Pharmaceuticals, New Haven, CT, USA.
Alexandra ThiryBiohaven Pharmaceuticals, New Haven, CT, USA.
Linda HarrisBiohaven Pharmaceuticals, New Haven, CT, USA.
Vladimir CoricBiohaven Pharmaceuticals, New Haven, CT, USA.
Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMigraine is a debilitating neurological condition, affecting up to 15% of Americans. Recent estimates from a long-term safety study of rimegepant showed evidence of decreased monthly migraine days (MMD) in people with episodic migraine treated with rimegepant 75 mg. The objective of this study was to characterize migraine-specific quality of life version 2.1 (MSQv2) scores and corresponding mapped EuroQol-5 Dimensions-3 Level (EQ-5D-3L) utility values.

methodsStudy participants were randomized into two treatment regimens: individuals with 2-14 MMD received rimegepant 75 mg as needed (PRN), and those with 4-14 MMD at baseline who received rimegepant on a fixed every-other-day schedule plus an as needed dose on days they did not treat (QOD + PRN). MSQv2 was mapped to EQ-5D-3L utilities using a validated algorithm. Outcomes were assessed for the PRN arm at baseline weeks 12, 24, 36, and 52 and for the QOD + PRN arm at baseline and week 12.

resultsAt baseline, MSQv2 data were available for 1,800 patients: 1,033 with 2-8 MMD in the PRN group, 481 with 9-14 MMD in the PRN group, and 286 with 4-14 MMD in the QOD + PRN group. For all MSQv2 domains as well as mapped utility values, outcomes improved over each study visit. At baseline, EQ-5D-3L utilities were 0.66, 0.63, and 0.65 for the 2-8 MMD PRN, 9-14 MMD PRN, and 4-14 MMD QOD + PRN groups, respectively. At end-of-study, utilities had increased by + 0.09, + 0.10, and + 0.12 for the three groups, respectively (p < 0.001 for all comparisons with baseline). Similar trends in improvement were observed across MSQv2 subdomains; all differences were statistically significant.

conclusionsRimegepant 75 mg, which has been shown to be associated with reduced MMD, is associated with improvement in MSQv2 domains over time, leading to estimated improvement in EQ-5D-3L utilities. While this improvement was observed in all patient-groups, it was most pronounced in those with higher MMD and those taking rimegepant QOD + PRN.

trial registrationClinical Trials NCT03266588.

Indexed as

Migraine DisordersQuality of LifeAlgorithmsHumansPiperidinesPyridinesSurveys and QuestionnairesPiperidinesPyridinesrimegepant sulfateEQ-5DMappingMigraineMigraine-specific quality of life (MSQv2)Patient-reported outcomePreference-based instrumentUtility

Identifiers

PMID34455556
PMCPMC8478726

What OpenQuestion holds

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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.