Abstract Details

Title Impact of Atogepant on Activity Limitation in Participants With Episodic Migraine and Chronic Migraine: Post Hoc Analyses of ADVANCE, ELEVATE, and PROGRESS

Topic Headache

Presentation(s) P9 - Poster Session 9 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-004

Objective To evaluate the proportion of participants treated with atogepant (Ato) versus placebo (Pbo) reporting they had no activity limitations on a daily diary measure with scores calculated for Weeks 1, 2, 3, and 4 across three phase 3 Ato trials.

Background Ato is an oral calcitonin gene-related peptide receptor antagonist approved for preventive treatment of migraine in adults. ADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, Pbo-controlled, 12-week trials that included adults with episodic migraine (EM), EM with prior inadequate responses to 2-4 classes of oral preventive treatments, and chronic migraine (CM), respectively.

Design/Methods This post-hoc analysis compared the proportion of participants who reported that they had no activity limitations when treated with Ato 60 mg once daily versus Pbo for Weeks 1, 2, 3, and 4 across three phase 3 clinical trials. Participants who reported at least some activity limitations at baseline answered a single question to evaluate activity limitation over the past 24 hours with a 5-level response scale ranging from “0-Not at all limited-I could do everything” to “4-Extremely limited”. Participants reporting no activity limitations reported “I could do everything” for all available days within each week.

Results

Across all three phase 3 trials, a higher proportion of participants treated with Ato compared with Pbo reported they could do everything at Week 1 [(ADVANCE: Ato, 43.2%(79/183), Pbo, 24.1%(38/158); P<0.001) (ELEVATE: Ato, 29.6%(40/135), Pbo, 6.5%(9/138); P<0.001) (PROGRESS: Ato, 11.5%(28/244), Pbo, 3.8%(9/239); P<0.01)]. The results were consistent at Weeks 2, 3, 4 and across the three phase 3 trials.

Conclusions

As early as week 1, after initiating Ato, a higher proportion of participants reported they could do everything compared with Pbo treated participants. The results were consistent at Weeks 2, 3, 4 across the three phase 3 trials and suggest the rapid onset of improved function in Ato treated participants.

Authors/Disclosures
Rashmi B. Halker Singh, MD, FAAN (Mayo Clinic) PRESENTER	Dr. Halker Singh 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. Dr. Halker Singh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Halker Singh 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. Halker Singh has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Neurology & Neuroscience Reports. Dr. Halker Singh has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Headache Journal. Dr. Halker Singh has received publishing royalties from a publication relating to health care. Dr. Halker Singh has received personal compensation in the range of $5,000-$9,999 for serving as a CME speaker with Pri-med. Dr. Halker Singh has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Medscape.
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 as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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 or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had 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.
Hsiangkuo Yuan, MD, PhD (Jefferson Headache Center)	An immediate family member of Dr. Yuan has received personal compensation for serving as an employee of Merck. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Dr. Yuan has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Salvia. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cerenovous. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Regional Anesthesia and Pain Medicine. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Headache and Pain Reports. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for MedLink Neurology. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. The institution of Dr. Yuan has received research support from NIH. The institution of Dr. Yuan has received research support from American Headache Society. The institution of Dr. Yuan has received research support from Pfizer. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received personal compensation in the range of $500-$4,999 for serving as a Grant reviewer with NIH. Dr. Yuan has received personal compensation in the range of $10,000-$49,999 for serving as a Invited speaker with Chinese Stroke Association.
Andreas Gantenbein, MD (ZURZACH Care)	Prof. Gantenbein has nothing to disclose.
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.
Kandavadivu Umashankar (AbbVie)	Kandavadivu Umashankar has received personal compensation for serving as an employee of AbbVie.
Molly Duan (Abbvie)	Molly Duan has received personal compensation for serving as an employee of AbbVie.
Jonathan Stokes (AbbVie)	Jonathan Stokes has nothing to disclose.
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 Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranicsa. 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.

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