A phase 3 study of the investigational migraine treatment erenumab (Amgen/Novartis) has met its primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine compared with placebo at 12 weeks.
Erenumab, a fully human monoclonal antibody, was designed to target and block the calcitonin gene-related peptide (CGRP) receptor, which is believed to have a critical role in mediating the pain of migraine.
The ARISE (A Phase 3, RandomIzed, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention) trial assessed erenumab in 577 patients with episodic migraine. The participants were randomly assigned to receive once-monthly subcutaneous erenumab (70 mg) or placebo for 12 weeks. Patients who completed the double-blind portion of the study had the option to continue in a long-term safety extension.
The patients enrolled in the study were experiencing between four to 14 migraine days each month. The trial’s primary endpoint was the change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase (i.e., the number of migraine days between weeks 9 and 12). Secondary endpoints included a reduction of at least 50% from baseline in monthly migraine days and the change from baseline in monthly acute migraine-specific medication treatment days. The Migraine Physical Function Impact Diary (MPFID), a scale developed to measure the effect of migraine on physical function and on everyday activities, assessed two additional secondary endpoints.
Patients receiving erenumab experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days compared with a 1.8-day reduction in the placebo arm.
The safety profile of erenumab was similar to that of placebo. The most common adverse events included upper respiratory tract infection, injection-site pain, and nasopharyngitis.
The World Health Organization (WHO) ranks migraine as one of the most debilitating illnesses. More than 40% of people with migraine go undiagnosed. Worldwide, approximately 90% of people diagnosed with migraine have episodic migraine, which is characterized by up to 14 migraine days per month. The remaining 10% have chronic migraine, which is characterized by at least 15 headache days per month, of which eight or more are migraine days, for more than three months.
Source: Amgen; September 28, 2016.