Atogepant 60 mg Once-Daily Shows Efficacy for the Preventive Treatment of Migraine: Results From a 52-Week Open-Label Extension Trial
Messoud Ashina1, Stewart Tepper2, Uwe Reuter3, Andrew Blumenfeld4, Susan Hutchinson5, Jing Xia6, Rosa Miceli7, Lawrence Severt7, Michelle Finnegan7, Joel Trugman7, Brett DaBruzzo7
1Dept. of Neurology, 2Geisel School of Medicine At Dartmouth, 3Charité University Hospital, 4Headache Center of Southern California, 5Orange County Migraine and Headache Center, 6Abbvie, 7AbbVie
Objective:
Evaluate long-term efficacy of once-daily oral atogepant 60-mg for the preventive treatment of migraine during the 52-week open-label extension trial.
Background:
Atogepant is an oral, calcitonin gene-related peptide (CGRP) receptor antagonist in development for the preventive treatment of migraine.
Design/Methods:
Adults with 4-14 migraine days in the 28-day baseline period were enrolled in the trial (NCT03700320) and randomized 5:2 to atogepant 60-mg once-daily or oral, standard care migraine preventive medication. Efficacy measures, changes from baseline in monthly-migraine-days (MMDs), moderate/severe headache days, acute medication use days, and the proportion of responders based on reductions in MMDs, were collected from the atogepant arm only and evaluated using the modified-intent-to-treat (mITT) population and a mixed-effects model for repeated measures.
Results:
744 participants were randomized (n=546 atogepant 60-mg arm) with 521 atogepant-treated participants in the mITT population, which had a mean age of 42.5 years. 88.3% were female, and 76.8% were White. The mean (standard error [SE]) MMDs at baseline was 7.30 (2.62); the least-squares (LS) mean change from baseline (95% confidence interval [CI]) MMDs at Weeks 1-4, was -3.84 (-4.10, -3.57) and -5.19 (-5.50, -4.87) at Weeks 49-52. Monthly moderate/severe headache days followed a similar trend to MMDs. Mean (SE) monthly acute medication use at baseline was 6.63 (3.26) days and the LS mean change (95% CI) at Weeks 1-4 was -4.04 (-4.28, -3.81) days and -4.93 (-5.20, -4.66) days at Weeks 49-52. Of participants who remained at Weeks 49-52, 84.2% (282/335) experienced a ≥50% reduction in MMDs, 69.9% (234/335) experienced ≥75% reduction in MMDs, and 48.4% (162/335) experienced a 100% reduction in MMDs; proportions of responders in each category increased throughout the trial.
Conclusions:
Atogepant 60-mg once-daily administered over a 52-week open-label trial was efficacious and results support the potential for use as a long-term, preventive treatment of episodic migraine.