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|Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine|
"Chronic migraine patients lose more than half of their life to migraines with 15 or more headache days a month, facing intolerable pain and physical impairment," said
The study included 667 patients (mean age 42.1, 79.0 percent female) who were randomized to receive either subcutaneous placebo (n=286) or subcutaneous erenumab 70 mg (n=191) or 140 mg (n=190) once a month. Patients had a mean baseline of 18.0 migraine days per month and a mean baseline of 21.1 headache days per month. Patients randomized to both erenumab dose groups experienced a statistically significant 6.6-day reduction from baseline in mean monthly migraine days compared with 4.2 days observed in the placebo group (p<0.001). All endpoint assessments compared the last four weeks of the 12-week treatment phase to baseline.
A reduction of 50 percent or more in number of monthly migraine days was observed in 40 percent and 41 percent (70 mg and 140 mg doses, respectively) of individuals in the erenumab groups at week 12, representing a significantly higher likelihood of response compared to 24 percent of those receiving placebo (both p<0.001). Reductions in monthly acute migraine-specific medication days were 3.5 days and 4.1 days in the 70 mg and 140 mg groups, respectively, representing significant improvements from baseline compared to a 1.6-day reduction in those receiving placebo (both doses p<0.001 versus baseline).
All groups showed numeric improvements in cumulative monthly headache hours. Compared to a 55.2-hour reduction versus baseline in the placebo group, reductions were 64.8 hours for 70 mg erenumab and 74.5 hours for 140 mg erenumab.
In an analysis of exploratory endpoints, both doses of erenumab were associated with significant improvements in health-related quality of life, headache impact, disability, and level of pain interference, compared to placebo.*
"Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine," said
The safety profile of erenumab was similar to placebo across both treatment arms. No adverse event was reported in greater than five percent of patients treated with erenumab. The most common adverse events (in placebo, 70 mg erenumab, 140 mg erenumab groups, respectively) were injection site pain (1.1 percent, 3.7 percent, 3.7 percent), upper respiratory tract infection (1.4 percent, 2.6 percent, 3.2 percent) and nausea (2.5 percent, 2.1 percent, 3.2 percent).
Results from Phase 3 studies investigating erenumab in episodic migraine are expected later this year. Erenumab is being co-developed by
*Assessment tools for exploratory endpoints including the Headache Impact Test (HIT-6™), the Migraine Disability Assessment (MIDAS), the Migraine-Specific Quality-of-Life Questionnaire (MSQ), and the Patient Reported Outcome Measurement Information System (PROMIS®). Pain Interference Scale Short Form. Exploratory endpoints were not adjusted for multiplicity.
About the 20120295 Study
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amgen-presents-positive-data-at-ehmtic-2016-demonstrating-erenumab-significantly-reduces-monthly-migraine-days-in-patients-with-chronic-migraine-300329018.html