BACKGROUND: 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.

Amgen Inc Thousand Oaks California USA

Atria Academy of Science and Medicine New York New York USA

Center for Interdisciplinary Research in Health Universidade Católica Portuguesa Lisboa Portugal

Department of Neurology Mayo Clinic Scottsdale Arizona USA

Department of Neurology Poznań University of Medical Sciences Poznań Poland

Department of Pain CHU Lille France

Inserm U1107 Neuro Dol Université Clermont Auvergne Clermont Ferrand France

Neurology Department Hospital da luz luz Saude Lisboa Portugal

Óbudai Egészségügyi Centrum Budapest Hungary

Pain Department and FHU InovPain Centre Hospitalier Universitaire de Nice Côte Azur and University Nice France

Prague Headache Center DADO MEDICAL Sro Prague Czech Republic

The New England Institute for Neurology and Headache Stamford Connecticut USA

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NCT03971071