Impact of Atogepant on Patient Functioning Among Participants With Episodic Migraine: Migraine-Specific Quality of Life Questionnaire v2.1 Item-Level Analysis
Richard Lipton1, Pranav Gandhi2, Dawn Buse1, Manjit Matharu3, Karen Carr2, Brett Dabruzzo2, Yingyi Liu2, Jonathan Stokes2, Patricia Pozo-Rosich4
1Albert Einstein College of Medicine, 2AbbVie, 3University College London, 4Universitat Autonoma of Barcelona
Objective:
To (1) evaluate improvement in Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) items between atogepant and placebo, and (2) understand the relationship between percent reduction in migraine days from baseline and MSQv2.1 items.
Background:
Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved in the US and EU for preventive treatment of migraine.
Design/Methods:
ADVANCE, a phase 3, multicenter, randomized, double-blind, placebo-controlled, 12-week trial, included adults with a ≥1-year history of migraine with or without aura who experienced 4–14 migraine days per month. Data based on atogepant 60 mg once daily (QD) and placebo treatment are presented. MSQv2.1 is a 14-item questionnaire measuring health-related quality-of-life attributed to migraine in the past 4 weeks and participants responded using a 6-point verbal response scale. MSQv2.1 was assessed via eTablet at baseline and Week 12. Improvement in MSQv2.1 items was assessed by comparing the proportion of participants at Week 12 reporting “none of the time” or “a little bit of the time” between atogepant and placebo using odds ratio. Relationships among category of percent reduction in migraine days from baseline (response categories: <25%, ≥25% to <50%, ≥50% to <75%, and ≥75% decrease) and MSQv2.1 items were evaluated using analysis of variance model.
Results:
Of the 910 participants randomized in ADVANCE, the modified intent-to-treat population included: atogepant 60 mg QD, n=222; placebo, n=214. Greater percentages of atogepant-treated participants (67.6%–74.6%) reported improvement from baseline in all MSQv2.1 items compared with 44.0%–66.4% on placebo (P<0.05 in 11 of 14 items). Greater mean changes (improvements) from baseline in individual item-level scores were observed with greater decreases in migraine days (P<0.0001 for all between-category comparisons within each item).
Conclusions:
This post-hoc analysis demonstrated greater improvement in each MSQv2.1 item among atogepant-treated participants relative to placebo, and greater improvement in patient functioning with greater percent reduction in migraine days.