Abstract Details

Title Long-Term Safety, Tolerability, and Efficacy of Atogepant for the Preventive Treatment of Migraine: Final Results from a Phase 3, Open-Label, 156-Week, Long-Term Safety Extension Study

Topic Headache

Presentation(s) LS1 - Late-breaking Science 1 (5:18 PM-5:24 PM)

Poster/Presentation
Number 004

Objective

To evaluate the long-term safety, tolerability, and efficacy of atogepant for the preventive treatment of migraine.

Background

Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine. PROGRESS and ELEVATE were phase 3, randomized, double-blind, placebo-controlled trials evaluating atogepant for the preventive treatment in participants with chronic migraine (CM) or episodic migraine (EM) who previously had an inadequate response to 2–4 classes of conventional oral preventive treatment, respectively.

Design/Methods

An open-label, 156-week, long-term safety extension study evaluated the safety, tolerability, and efficacy of atogepant 60 mg once daily for the preventive treatment of CM or EM in participants who completed the PROGRESS or ELEVATE trials. The primary outcome was safety. Exploratory endpoints were prespecified and included change from baseline (CFB) in mean monthly migraine days (MMDs), monthly acute medication use days (MAMDs), and ≥50% responder rate (RR).

Results

The safety population included 595 participants (PROGRESS, n=325; ELEVATE, n=270). Overall, 63.2% of participants completed the 3-year open-label treatment period. Treatment-emergent adverse events (TEAEs) occurred in 83.2% of participants. Common TEAEs (≥10%) were COVID-19 (33.6%) and nasopharyngitis (15.5%). Serious TEAEs occurred in 8.7% of participants, including one death attributed to asphyxia by housefire, and none were related to atogepant. TEAEs leading to discontinuation occurred in 6.7% of participants. ALT/AST ≥3 x ULN occurred in 3 participants; none met Hy’s Law. Least square (LS) mean CFB in MMDs at Weeks 13-16 was −8.2 (95% CI: −8.7 to −7.7) and consistent over 156 weeks [LS mean CFB at Weeks 153-156 was −9.2 (95% CI: −9.8 to −8.7)]. Consistent improvements were also observed for CFB in MAMDs and ≥50% RR.

Conclusions

Atogepant was safe and well-tolerated over 156 weeks for the preventive treatment of migraine. No new safety signals were identified. Improvements in efficacy outcomes were consistent over 156-weeks.

Authors/Disclosures
Jonathan H. Smith, MD (AbbVie) PRESENTER	Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
Messoud Ashina, MD, PhD (Dept. of Neurology)	Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Incyte. The institution of Dr. Ashina has received research support from The Lundbeck Foundation. The institution of Dr. Ashina has received research support from Novo Nordisk Foundation . The institution of Dr. Ashina has received research support from Danish National Research Foundation . Dr. Ashina has received publishing royalties from a publication relating to health care.
Sait Ashina, MD (Beth Israel Deaconess Medical Center, Harvard Medical School)	Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer.
Cristina Tassorelli	Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Organon. Cristina Tassorelli has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Organon. Cristina Tassorelli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva . The institution of Cristina Tassorelli has received research support from Abbvie.
Peter Goadsby, MD, PhD, FRS (King Abdullah Univeristy of Science and Technology)	Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health LLC. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kallyope. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seaport Therapeutics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr Reddy's. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion Pharma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from NIHR. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities.
Soo-Jin Cho, MD	Dr. Cho has nothing to disclose.
Rebeka Man	Ms. Man has received personal compensation for serving as an employee of Abbvie. An immediate family member of Ms. Man has received personal compensation for serving as an employee of Eli Lilly. An immediate family member of Ms. Man has received personal compensation for serving as an employee of Servier Pharmaceuticals. An immediate family member of Ms. Man has received personal compensation for serving as an employee of BioMarin Pharmaceutical.
Hua Guo, PhD (AbbVie)	Dr. Guo has received personal compensation for serving as an employee of AbbVie. Dr. Guo has or had stock in AbbVie.
eric cohen, MD	Dr. cohen has nothing to disclose.
Krisztian Nagy, MD (AbbVie)	Dr. Nagy has received personal compensation for serving as an employee of AbbVie. Dr. Nagy has or had stock in AbbVie.