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Abstract Details

Impact of Atogepant on Patient Functioning Among Participants With Episodic Migraine: Migraine-Specific Quality of Life Questionnaire v2.1 Item-Level Analysis
Headache
P8 - Poster Session 8 (5:30 PM-6:30 PM)
12-002
Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved in the US and EU for preventive treatment of migraine. 
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. 
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. 
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).
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.
Authors/Disclosures
Karen Carr, PhD
PRESENTER
Dr. Carr has nothing to disclose.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
Pranav Gandhi Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc.
Dawn C. Buse, PhD (Dawn C. Buse, PhD) Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Collegium. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
No disclosure on file
Brett Dabruzzo, PharmD (AbbVie Medical Affairs) Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
No disclosure on file
No disclosure on file
Patricia Pozo-Rosich, MD, PhD Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Foundation Spain. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.