Atogepant Demonstrates Reduction in Mean Monthly Migraine Days for Those Who Previously Failed Multiple Preventive Treatments

Results of a phase 3 study of atogepant (Qulipta; AbbVie, Chicago, IL), an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, showed that adults with episodic migraines who had previously failed two to four prophylactic treatments, had a decrease in mean monthly migraine days (MMDs) when treated with the drug. These results were scheduled to be presented on Tuesday, April 25 at the American Academy of Neurology (AAN) 2023 Annual Meeting in Boston, MA.

In the ELEVATE trial (NCT04740827), adult patients in the atogepant 60 mg once daily arm experienced a decrease of 4.20 days in their MMDs across the 12-week treatment period, which was greater than the 1.85 day reduction observed in the placebo arm (P<.0001). The study met all primary and secondary endpoints. The primary endpoint was the change from baseline in mean MMDs across 12 weeks and the secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use across 12 weeks.

“For those living with migraine, the path towards effective treatment can be a long and complex journey,” said Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d’Hebron Hospital and Institute of Research, Spain. “The ELEVATE trial demonstrates atogepant as a once-daily oral treatment that can significantly reduce monthly migraine days across a lifelong disorder, allowing people to experience relief in their daily lives, including those who have previously been failed by other preventive migraine treatments.”

A total of 309 participants with episodic migraines were enrolled in the study of which 56% had previously failed 2 classes of oral migraine preventive medications and 44% had previously failed 3 or more classes. The most commonly reported (≥5% in any treatment arm) treatment-emergent adverse events (atogepant vs placebo, respectively) included constipation (10.3% vs 2.5%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).