Evidence map›Paper›PMID 34537006›Full record

Trial reportThe journal of headache and pain2021

Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial.

Koichi Hirata, Fumihiko Sakai, Takao Takeshima, Noboru Imai, Yasuhiko Matsumori, Ryuji Yoshida, Yotaro Numachi, Cheng Peng, Daniel D Mikol, Sunfa Cheng

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812224 (A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT03812224 phase3completednot on this map

A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention

TypeinterventionalSponsorAmgenRan2019 to 2020Enrolled261ConditionsMigraineArmsErenumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Review
  9. 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

10 authors.

Koichi HirataDepartment of Neurology Headache Center, Dokkyo Medical University, 880 Kitakobayashi, Mibu, Shimotsuga District, Tochigi, 321-0293, Japan. hirata@dokkyomed.ac.jp.
Fumihiko SakaiSaitama International Headache Center, Saitama, Japan.
Takao TakeshimaDepartment of Neurology Headache Center, Tominaga Hospital, Osaka, Japan.
Noboru ImaiDepartment of Neurology, Japanese Red Cross Shizuoka Hospital, Shizuoka, Japan.
Yasuhiko MatsumoriSendai Headache and Neurology Clinic, Sendai, Japan.
Ryuji YoshidaAmgen K.K, Tokyo, Japan.
Yotaro NumachiAmgen K.K, Tokyo, Japan.
Cheng PengGlobal Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.
Daniel D MikolGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.
Sunfa ChengGlobal Development, Amgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThese subgroup analyses of a Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of erenumab 70 mg in Japanese migraine patients with/without prior preventive treatment failure(s) ("failed-yes" and "failed-no" subgroups) and with/without concomitant preventive treatment ("concomitant preventive-yes" and "concomitant preventive-no" subgroups).

methodsOverall, 261 patients were randomized; 130 and 131 patients to erenumab 70 mg and placebo, respectively. Subgroup analyses evaluated the change from baseline to Months 4-6 in mean monthly migraine days (MMD) (primary endpoint), achievement of a ≥50% reduction in mean MMD, and change from baseline in mean monthly acute migraine-specific medication (MSM) treatment days. Treatment-emergent adverse events were also evaluated.

resultsOf the 261 patients randomized, 117 (44.8%) and 92 (35.3%) patients were in the failed-yes and concomitant preventive-yes subgroups, respectively. Erenumab 70 mg demonstrated consistent efficacy across all subgroups, with greater reductions from baseline in mean MMD versus placebo at Months 4-6 (treatment difference versus placebo [95% CI], failed-yes: - 1.9 [- 3.3, - 0.4]; failed-no: - 1.4 [- 2.6, - 0.3]; concomitant preventive-yes: - 1.7 [- 3.3, 0.0]; concomitant preventive-no: - 1.6 [- 2.6, - 0.5]). Similar results were seen for achievement of ≥50% reduction in mean MMD and change from baseline in mean monthly acute MSM treatment days. The safety profile of erenumab 70 mg was similar across subgroups, and similar to placebo in each subgroup.

conclusionErenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with/without prior preventive treatment failure(s) and with/without concomitant preventive treatment.

trial registrationClinicaltrials.gov . NCT03812224. Registered January 23, 2019.

Indexed as

Migraine DisordersSexual and Gender MinoritiesAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodHumansJapanTreatment FailureTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabConcomitant preventive treatmentErenumabMigrainePrior preventive treatment failure

Identifiers

PMID34537006
PMCPMC8449906

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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.