Objective:

Evaluate the impact of atogepant 60mg once daily (QD) on migraine headache day severity in participants with episodic migraine (EM).

Background:

Atogepant is an oral, calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine. 

Design/Methods:

This post hoc analysis included participants with EM from the phase 3, randomized, double blind, placebo-controlled, 12-week ADVANCE trial and phase 3, randomized, 52-week, open-label trial. Outcomes included change from baseline in the number of monthly moderate/severe migraine headache days and change from baseline in mean pain severity of migraine headache days, including resolved days. If the number of monthly migraine days at a post-baseline period was reduced from baseline, a pain severity score of 0 was imputed for any resolved migraine headache days.

Results:

The modified intent-to-treat population included participants from ADVANCE (placebo, N=214; atogepant 60mg QD, N=222) and the open-label trial (atogepant 60mg QD, N=520). At Weeks 9–12 in ADVANCE, the number of monthly moderate/severe migraine headache days was reduced by 64% with atogepant compared to baseline (vs. 43% reduction with placebo), and the change from baseline in mean pain severity of migraine headache days, including resolved days, was -1.46 for atogepant and -0.97 for placebo. In the open-label trial, the number of monthly moderate/severe migraine headache days was reduced by 57% at Weeks 1–4 compared to baseline, which improved to a 78% reduction at Weeks 49–52 compared to baseline. The change from baseline in mean pain severity of migraine headache days, including resolved days, was -1.30 at Weeks 1–4 and decreased to -1.73 at Weeks 49–52. Atogepant was safe and well tolerated in both trials.

Conclusions:

Atogepant reduced the number of monthly moderate/severe migraine headache days and mean pain severity of migraine headache days compared with placebo in ADVANCE, and reductions were consistent across 52 weeks in the open-label trial.