Atogepant Reduced Monthly Migraine Days in Participants With Chronic Migraine

Data from the phase 3 PROGRESS trial (NCT03855137) participants with chronic migraine treated with atogepant vs placebo (Qulipta; AbbVie, Chicago, IL) had significant reductions in monthly migraine days (MMD). Atogepant is a small-molecule inhibitor of calcitonin gene-related peptide (CGRP) thatt has been approved by the Food and Drug Administration for preventive treatment of episodic migraine. 

In the modified intention to treat (mITT) population, individuals (n=755) treated with 60 mg atogepant once daily or 30 mg twice daily had 6.88 (P=.0009) and 7.46 (P<.0001) fewer MMD, respectively, vs 5.05 fewer MMD in those treated with placebo.

In the off-treatment hypothetical estimand (OTHE)population (n=760), individuals treated with 60 mg/day of atogepant vs placebo in 1 or 2 doses/day for 12 weeks had decreases of 6.75 (P =.0024) and 7.33 (P<.0001) MMD, respectively, vs 5.09  

"AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating disease. We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options," said Michael Severino, MD, vice chairman and president, AbbVie. "These data and pending regulatory submissions solidify our commitment to our leading migraine portfolio to help the more than one billion people worldwide living with the migraine. We look forward to taking the next steps to potentially expand the use of atogepant in the US to include the preventive treatment of chronic migraine in adults, and to working with regulatory agencies globally on additional submissions."

The modified intention-to-treat (mITT) population included participants with evaluable headache eDiary data collected during the double-blinded treatment period. The OTHE population included 760 patients with evaluable headache eDiary data collected during the double-blind treatment period and the follow-up period. 

A total of 778 participants with at least a 1-year history of chronic migraine were enrolled and randomly assigned to receive 60 mg atogepant once per day, 30 mg atogepant twice/day, or placebo. The most common adverse events reported with a frequency > 5% in at least 1 atogepant treatment arm, and greater than placebo, were constipation and nausea.