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Efficacy and safety of erenumab in adults with medication overuse headache: final results from a phase 4 randomized placebo-controlled study

2025-08-01Artigo de investigação Acesso aberto
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dc.contributor.authorTepper, Stewart J.
dc.contributor.authorDodick, David W.
dc.contributor.authorLanteri-Minet, Michel
dc.contributor.authorDolezil, David
dc.contributor.authorGil-Gouveia, Raquel
dc.contributor.authorLucas, Christian
dc.contributor.authorPiasecka-Stryczynska, Karolina
dc.contributor.authorSzabó, Gyöngyi
dc.contributor.authorMikol, Daniel D.
dc.contributor.authorChehrenama, Mahan
dc.contributor.authorChou, Denise E.
dc.contributor.authorLiu, Zilu
dc.contributor.authorLima, Gabriel Paiva da Silva
dc.date.accessioned2025-09-05T06:57:43Z
dc.date.available2025-09-05T06:57:43Z
dc.date.issued2025-08-01
dc.description.abstractBackground: Erenumab-induced medication overuse headache (MOH) remission in participants with chronic migraine (CM) in a prospective, Phase 4, randomized, placebo-controlled trial with an open-label treatment period (OLTP). We present 1-year results from the combined double-blind treatment period (DBTP) and OLTP for the stratified nonopioid cohort. Methods: Participants with CM-MOH were randomized 1:1:1 to subcutaneous 70 or 140 mg erenumab every 4 weeks (QM) or placebo for the initial 24 weeks (DBTP). Those successfully completing DBTP could continue the 28-week OLTP, maintaining the same erenumab dose received during DBTP or, if receiving placebo, randomly assigned 1:1 to erenumab 70 or 140 mg QM. OLTP endpoints were exploratory. Results: Overall, 552 participants received erenumab (70 mg, n = 274; 140 mg, n = 278); 95.3% completed OLTP. One-year MOH relapse in participants who achieved MOH remission at DBTP Month 6 was 2.7% (3/111) and 2.4% (3/124) with erenumab 70 and 140 mg, respectively; absence of MOH at study end was observed in 69.0% (189/274) and 75.5% (210/278) of participants. Sustained MOH absence over 1 year was reported in 60.5% (107/177) and 68.8% (119/173) of participants, respectively. Sustained improvements in measures of headache days, medication days, and function were observed in both groups. No new safety concerns were identified (grade ? 3, 35 [6.3%]; serious, 17 [3.1%]; adverse events leading to treatment discontinuation, 5 [0.9%]). Conclusions: Erenumab was effective in inducing and sustaining MOH remission and improving function over 1 year. Treatment compliance remained high, with safety events consistent with erenumab's known safety profile. Trial Registration: NCT03971071.eng
dc.identifier.citationTepper, S. J., Dodick, D. W., Lanteri-Minet, M., & Dolezil, D. et al. (2025). Efficacy and safety of erenumab in adults with medication overuse headache: final results from a phase 4 randomized placebo-controlled study. European Journal of Neurology, 32(8), Article e70328. https://doi.org/10.1111/ene.70328
dc.identifier.doi10.1111/ene.70328
dc.identifier.eid105013975813
dc.identifier.issn1351-5101
dc.identifier.other736185e7-dee6-4b1a-8751-e044cd0506d8
dc.identifier.pmcPMC12368597
dc.identifier.pmid40838472
dc.identifier.urihttp://hdl.handle.net/10400.14/54649
dc.identifier.wos001562661300011
dc.language.isoeng
dc.peerreviewedyes
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectCalcitonin gene-related peptide
dc.subjectClinical trial
dc.subjectErenumab
dc.subjectHeadache disorders
dc.subjectMigraine disorders
dc.subjectSecondary
dc.titleEfficacy and safety of erenumab in adults with medication overuse headache: final results from a phase 4 randomized placebo-controlled studyeng
dc.typeresearch article
dspace.entity.typePublication
oaire.citation.issue8
oaire.citation.titleEuropean Journal of Neurology
oaire.citation.volume32
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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