Evidence map›Paper›PMID 34845002›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2022

Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study.

Michel Dominique Ferrari, Uwe Reuter, Peter J Goadsby, Gabriel Paiva da Silva Lima, Subhayan Mondal, Shihua Wen, Nadia Tenenbaum, Shaloo Pandhi, Michel Lanteri-Minet, Tracy Stites

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03096834 (A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT03096834 phase3completednot on this map

A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2021Enrolled246ConditionsEpisodic MigraineArmsAMG334 (70 mg) Pre-Filled Syringe (PFS), Placebo Pre-Filled Syringe (PFS)
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

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  6. Monoclonal antibodies targeting the calcitonin gene-related peptide pathway improve the effectiveness of acute medication-a real-world study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
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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

10 authors at 8 institutions in 7 countries.

Michel Dominique FerrariDepartment of Neurology, Leiden University Medical Center, 2300 RC Leiden, Netherlands m.d.ferrari@lumc.nl.
Uwe ReuterDepartment of Neurology, Charite Universitatsmedizin Berlin, Berlin, Germany.
Peter J GoadsbyNIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.ORCID 0000-0003-3260-5904
Gabriel Paiva da Silva LimaAmgen Inc, Thousand Oaks, California, USA.
Subhayan MondalBiostatistics and Pharmacometrics, Novartis Healthcare Pvt Ltd, Hyderabad, India.ORCID 0000-0001-7267-8505
Shihua WenNovartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.
Nadia TenenbaumNovartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.
Shaloo PandhiNovartis Pharma AG, Basel, Basel-Stadt, Switzerland.
Michel Lanteri-MinetPain Department and FHU InovPain, Centre Hospitalier Universitaire de Nice, Nice, France.
Tracy StitesNovartis Pharmaceuticals Corp, East Hanover, New Jersey, USA.ORCID 0000-0001-7722-2005
Novartis (United States) · USAmgen (United States) · USInserm · FRLeiden University Medical Center · NLNovartis (India) · INNovartis (Switzerland) · CHUniversitätsmedizin Greifswald · DEUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate individual and group long-term efficacy and safety of erenumab in individuals with episodic migraine (EM) for whom 2-4 prior preventatives had failed.

methodsParticipants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140 mg monthly for up to 3 years. Main outcomes assessed at week 112 were: ≥50%, ≥75% and 100% reduction in monthly migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability.

resultsOverall 240/246 (97.6%) entered the OLEP (118 continuing erenumab, 122 switching from placebo). In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%). The ≥50% responder rate was 57.2% (99/173) at 112 weeks. Of ≥50% responders at the end of the DBTP, 36/52 (69.2%) remained responders at ≥50% and 22/52 (42.3%) at >80% of visits. Of the non-responders at the end of the DBTP, 60/185 (32.4%) converted to ≥50% responders in at least half the visits and 24/185 (13.0%) converted to ≥50% responders in >80% of visits. Change from baseline at 112 weeks in mean (SD) MMD was -4.2 (5.0) days. Common AEs (≥10%) were nasopharyngitis, influenza and back pain.

conclusionsEfficacy was sustained over 112 weeks in individuals with difficult-to-treat EM for whom 2-4 prior migraine preventives had failed. Erenumab treatment was safe and well tolerated, in-line with previous studies. TRIAL REGISTRATION NUMBER: NCT03096834.

Indexed as

AdultAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor AntagonistsDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersTreatment OutcomeAntibodies, Monoclonal, HumanizedCalcitonin Gene-Related Peptide Receptor Antagonistserenumabdrug trialsmigrainerandomised trials

Identifiers

PMID34845002
PMCPMC8862066
OpenAlexW3215765922

What OpenQuestion holds

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LicenceCC BY-NC
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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.