Evidence map›Paper›PMID 34301173›Full record

Trial reportThe journal of headache and pain2021

Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials.

Stewart J Tepper, Messoud Ashina, Uwe Reuter, Yngve Hallström, Gregor Broessner, Jo H Bonner, Hernan Picard, Sunfa Cheng, Denise E Chou, Feng Zhang and 2 more

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
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 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT02066415 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

TypeinterventionalSponsorAmgenRan2014 to 2016Enrolled667ConditionsTreatment for Prevention of Chronic MigraineArmsErenumab, Placebo
NCT02174861 phase2completednot on this map

An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334

TypeinterventionalSponsorAmgenRan2014 to 2017Enrolled609ConditionsTreatment for Prevention of Chronic MigraineArmsErenumab
NCT02456740 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

TypeinterventionalSponsorAmgenRan2015 to 2017Enrolled955ConditionsMigraineArmsErenumab, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Observational
  2. Article
  3. Review
  4. Reaching the Nadir of Medication Overuse in Chronic Migraine.International journal of environmental research and public health · 2022
    Article
  5. Assessment and characteristics of Erenumab therapy on migraine management.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
    Article
  6. Article
  7. Article
  8. 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

12 authors at 8 institutions in 6 countries.

Stewart J TepperGeisel School of Medicine at Dartmouth, Hanover, NH, USA. sjtepper@gmail.com.
Messoud AshinaDanish Headache Center, Department of Neurology, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.
Uwe ReuterDepartment of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Yngve HallströmNeuro Center, St Görans Hospital, Stockholm, Sweden.
Gregor BroessnerDepartment of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria.
Jo H BonnerMercy Clinic Neurology and Headache Centre, Saint Louis, MO, USA.
Hernan PicardAmgen Inc, Thousand Oaks, CA, USA.
Sunfa ChengAmgen Inc, Thousand Oaks, CA, USA.
Denise E ChouAmgen Inc, Thousand Oaks, CA, USA.
Feng ZhangAmgen Inc, Thousand Oaks, CA, USA.
Jan KlattNovartis Pharma AG, CH-4002, Basel, Switzerland.
Daniel D MikolAmgen Inc, Thousand Oaks, CA, USA.
Amgen (United States) · USCharité - Universitätsmedizin Berlin · DEDartmouth College · USInnsbruck Medical University · ATMercy Clinic Neurology · USNovartis (Switzerland) · CHSaint Göran Hospital · SEUniversity of Copenhagen · DK

Funding

Amgen AmgenNovartis Pharma (AG) Novartis Pharma (AG)
6 · The paper itself

Abstract

backgroundIn patients with migraine, overuse of acute medication, including migraine-specific medication (MSM) such as triptans and ergots, can lead to adverse health outcomes, including development of medication overuse headache. Here, we examined the effect of erenumab on reducing acute medication use, in particular MSM, in patients with episodic migraine (EM) and chronic migraine (CM).

methodsThe current post-hoc analyses were based on data from the double-blind treatment phase (DBTP) of two erenumab studies, a pivotal EM (N = 955) and a pivotal CM (N = 667) trial, and their respective extensions. Patients were administered subcutaneous placebo or erenumab (70 or 140 mg) once monthly. Daily acute headache medication use (including MSM and non-MSM) was recorded using an electronic diary during a 4-week pretreatment baseline period until the end of the treatment period. Outcome measures included change in monthly acute headache medication days (HMD) in acute headache medication users at baseline, and changes in monthly MSM days (MSMD) in MSM users at baseline and non-MSMD in non-MSM users at baseline.

resultsIn total, 60 and 78 % of patients (all acute headache medication users) with EM and CM used MSM at baseline, respectively. For acute headache medication users, the change in mean monthly acute HMD over Months 4, 5 and 6 compared with the pre-DBTP was 1.5, 2.5, and 3.0 for placebo, erenumab 70 mg and 140 mg, respectively for the EM study. The respective change in monthly MSMD in MSM users was 0.5, 2.1 and 2.8, and in monthly non-MSMD in non-MSM users was 2.3, 2.6, and 2.7. In the acute headache medication users at baseline, the change in monthly acute HMD at Month 3 compared with pre-DBTP was 3.4, 5.5, and 6.5 for placebo, erenumab 70 mg and 140 mg, respectively for the CM study. The respective change in monthly MSMD in MSM users was 2.1, 4.5, and 5.4, and in monthly non-MSMD in non-MSM users was 5.9, 6.4, and 6.6. Reductions in MSMD versus placebo were sustained in the extension periods of both studies. Erenumab was also associated with a higher proportion of MSM users achieving ≥ 50 %, ≥ 75 and 100 % reduction from baseline in monthly MSMD versus placebo in both EM and CM.

conclusionsIn both EM and CM, treatment with erenumab is associated with a significant and sustained reduction in the use of acute headache medication, in particular MSM. TRIAL REGISTRATIONS: NCT02456740; NCT02066415; NCT02174861.

Indexed as

Migraine DisordersAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistserenumabCGRP receptorChronic migraineEpisodic migraineErenumabMigraine-specific

Identifiers

PMID34301173
PMCPMC8299690
OpenAlexW3185132026

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.