Abstract Details

Title Impact of Atogepant on Functional Outcomes in Trial Completers for the Preventive Treatment of Episodic Migraine: A Post-Hoc Analysis of the ADVANCE Trial

Topic Headache

Presentation(s) S35 - Hot Topics in Headache (1:24 PM-1:36 PM)

Poster/Presentation
Number 003

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

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

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.

Authors/Disclosures
Umer Najib, MD, FAAN (West Virginia University Hospitals) PRESENTER	Dr. Najib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Najib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck . Dr. Najib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie . The institution of Dr. Najib has received research support from Eli Lilly. The institution of Dr. Najib has received research support from Abbvie.
Andrew M. Blumenfeld, MD, FAAN (The Los Angeles Headache Center)	Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck.
Pranav Gandhi	Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc.
Belinda A. Savage-Edwards, MD, FAAN (Rehabilitation & Neurological Services)	The institution of Dr. Savage-Edwards has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Llly. The institution of Dr. Savage-Edwards has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Easai. The institution of Dr. Savage-Edwards has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. The institution of Dr. Savage-Edwards has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Association of Neurology Journal. Dr. Savage-Edwards has stock in Eli Lilly. Dr. Savage-Edwards has stock in AbbVie. The institution of Dr. Savage-Edwards has received research support from Eli LIlly Co.. The institution of Dr. Savage-Edwards has received research support from AbbVie. The institution of Dr. Savage-Edwards has received research support from IQVIA.
Yingyi Liu (AbbVie)	Yingyi Liu has received personal compensation for serving as an employee of AbbVie.
Natty Chalermpalanupap, PhD (AbbVie)	Dr. Chalermpalanupap has received personal compensation for serving as an employee of AbbVie. Dr. Chalermpalanupap has stock in AbbVie.
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.
Jonathan Stokes (AbbVie)	Jonathan Stokes has nothing to disclose.
Dagny N. Holle, MD	Dr. Holle has nothing to disclose.

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