In the one-year OLE study in chronic migraine, the primary and secondary outcome measures of the study were long-term safety and efficacy, respectively.1 The safety results after one year were consistent with the established safety profile of Aimovig in previous studies. The most frequent adverse events (AEs) greater than 2.0 per 100-subject-years were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, arthralgia and migraine. In the double-blind treatment phase, no differences were observed in the safety events between Aimovig and placebo.
The efficacy data showed sustained benefits up to one year. Patients taking Aimovig 140 mg and 70 mg (based on last dose received) achieved reductions of average monthly migraine days of 10.5 and 8.5 days, respectively, compared to a baseline of 18.1 (at the time of enrollment into the placebo-controlled study, after one year of treatment). Patients treated with Aimovig experienced reductions in monthly migraine days of:
"These data showing sustained efficacy and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know," said
The five-year OLE study in episodic migraine is assessing the long-term safety and tolerability of Aimovig.2 The results at the three-year interim data analysis showed Aimovig had a safety profile consistent with the spectrum and rate of AEs seen in shorter-term placebo-controlled studies, no new AEs and no new causally-related serious AEs. The most frequent AEs were viral upper respiratory tract infection, upper respiratory tract infection, sinusitis, influenza and back pain. There was no increase in cardiovascular events over time and no meaningful changes in systolic/diastolic blood pressure or heart rate up to the ~3.2-year follow-up.2
"On the heels of the recent
Additional data in patients with chronic migraine are being presented at the AHS meeting, including long-term efficacy of Aimovig in patients with overuse of acute medication, long-term efficacy of Aimovig in patients who failed prior prophylactic treatment, and efficacy of Aimovig at varying dosage strengths in the Phase 3 STRIVE study.
About the Open-Label Extension Study in Chronic Migraine
After the 12-week randomized, double-blind placebo-controlled parent study, eligible patients could enroll in the OLE study. 451 patients completed the study receiving either Aimovig 70 mg, 140 mg or changing from 70 mg to 140 mg during the course of the study.1 Of the 609 patients who enrolled in the study, 199 increased their dose from 70 mg to 140 mg by week 28.1
The primary outcome measure of the study was long-term safety. The secondary outcome measure was efficacy, as determined by four measures: change from baseline to week 52 in monthly migraine days (MMD), monthly acute migraine-specific medication days, monthly cumulative hours of headache, and proportion of patients achieving at least a 50 percent reduction in MMD.
About the Open-Label Extension Study in Episodic Migraine
Following a 12-week randomized, placebo-controlled phase of a (Phase 2) study of Aimovig in adults with episodic migraine, patients could continue into the open-label extension phase, initially receiving 70 mg Aimovig monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring AEs, electrocardiograms, laboratory assessments and vital signs. Of the 383 patients who enrolled in the open-label extension, 235 patients (61.3 percent) remained in the OLE study at the data cutoff point for this interim analysis, all having received Aimovig for at least three years. The study is continuing for up to five years of treatment.
Safety and efficacy data after four and five years of treatment will be reported in the future.
About Aimovig™ (erenumab-aooe)
Aimovig is the only
U.S. Aimovig Indication
Aimovig is indicated for the preventive treatment of migraine in adults.
U.S. Aimovig Important Safety Information
People with frequent migraine may lose more than half their life to migraine. They endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.3 The 2016 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.4 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.3
About Amgen and Novartis Neuroscience Collaboration
Forward Looking Statements
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1 Tepper S, et al. Assessment of the Long-Term Safety and Efficacy of Erenumab During Open-Label Treatment of Subjects With Chronic Migraine. Data presented at 60th Annual Scientific Meeting of the
2 Ashina M, et al. Long-term Safety and Tolerability of Erenumab: Three-plus Year Results from an Ongoing Open-Label Extension Study in Episodic Migraine. Data presented at 60th Annual Scientific Meeting of the
3 Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
4 GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;388:1545-1602.
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