Although erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3-12 months, little is known about long-term therapy.
Open-label, 5-year treatment phase following a 12-week, double-blind, placebo-controlled trial in adults with episodic migraine. Patients initially received open-label erenumab 70 mg; increased to 140 mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMD), monthly acute migraine-specific medication (AMSM) days, and health-related quality of life.
Of 383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open-label treatment. Mean (SE) change in MMD from baseline of 8.7 (0.2) days was -5.3 (0.3) days; an average reduction of 62.3% at year 5. Among patients using AMSM at baseline (6.3 [2.8] treatment days), mean change in monthly AMSM days was -4.4 (0.3) days at the end of 5 years. Patient-reported outcomes indicated stable improvements in disability, headache impact, and migraine-specific quality of life. Exposure-adjusted patient incidence rates of adverse events were 123.0/100 patient-years; most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs reported by 49 patients (3.8/100 patient-years) were mostly single occurrence. Two fatal adverse events were reported. There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure.
Treatment with erenumab was associated with reductions in migraine frequency and improvements in health-related quality of life that were maintained for at least 5 years. No new safety signals were observed.

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