Objective:

Evaluate the impact of atogepant 60 mg once daily (QD) on functional outcomes in ADVANCE trial completers.

Background:

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

Design/Methods:

This post hoc analysis evaluated participants with episodic migraine (EM) from the phase 3, randomized, double-blind, placebo (Pbo)-controlled ADVANCE trial who completed ≥84 days of treatment, had non-missing data for all visits, and received Ato 60 mg QD or placebo. Least squares mean difference (LSMD) change from baseline (CFB) for Ato vs Pbo were calculated for Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) domains (Role Function Restrictive [RFR], Role Function Preventive [RFP], and Emotional Function [EF]) and Headache Impact Test-6 (HIT-6) at Weeks 4, 8, and 12; and Activity Impairment in Migraine-Diary (AIM-D) domains (Performance of Daily Activities [PDA] and Physical Impairment [PI]) at Weeks 1–4, 5–8, and 9–12.

Results:

The modified intent-to-treat population included Ato (N=176) and Pbo (N=178) trial completers. Participants receiving Ato compared with Pbo showed greater improvements from baseline in all MSQv2.1 domains at Week 4 (LSMD CFBs: 14.25 [95% CI: 9.70, 18.81] for RFR, 10.19 [95% CI: 6.01, 14.37] for RFP, and 12.15 [95% CI: 7.22, 17.09] for EF [nominal P<0.0001 for all]). Reduction in HIT-6 score was greater in Ato relative to Pbo at Week 4 (LSMD CFB: -3.63 [95% CI: -5.09, -2.17]; nominal P<0.0001). Results were consistent at Weeks 8 and 12 for MSQv2.1 and HIT-6. Improvement in AIM-D scores were observed among participants receiving Ato relative to Pbo at Weeks 1–4 (LSMD CFBs: -4.30 [95% CI: -5.86, -2.74] for PDA and -3.14 [95% CI: -4.41, -1.87] for PI [nominal P<0.0001 for both]). Reductions persisted at weeks 5-8 and 9-12.

Conclusions:

Completers who received Ato 60 mg QD demonstrated greater improvements in functional outcomes relative to Pbo at all time points.