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Abstract Details

Benefit-Risk Assessment of Atogepant: A Post Hoc Analysis of the ADVANCE Trial
Headache
P12 - Poster Session 12 (5:30 PM-6:30 PM)
2-001
To determine the number needed to treat (NNT) and number needed to harm (NNH) for atogepant for the preventive treatment of episodic migraine (EM).
Atogepant is an oral calcitonin gene?related peptide receptor antagonist approved for the preventive treatment of EM in adults. NNT and NNH are clinically relevant assessments of effect size that can inform management. The Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Role Function-Restrictive (RFR) domain assesses impacts of migraine on daily functioning that are important to people with migraine.
The ADVANCE trial (NCT02848326) was a 12-week, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of atogepant for the preventive treatment of EM. The NNT was calculated based on achievement of a ≥50% decrease in mean monthly migraine days (MMDs) (NNT≥50%) across 12 weeks. A second NNT was calculated based on achievement of a ≥10.9-point clinically relevant improvement from baseline in MSQ-RFR score (NNTMSQ-RFR) at week 12. NNH was calculated using the proportion of participants reporting a treatment-emergent adverse event (TEAE) leading to discontinuation.
A 50% reduction of MMDs from baseline was achieved by 56%-61% of atogepant participants versus 29% of placebo participants. The calculated NNTs≥50% for atogepant 10 mg, 30 mg, and 60 mg were 3.8, 3.4, and 3.1, respectively. The NNTsMSQ-RFR for the atogepant dose groups were 5.9, 5.7, and 6.3, respectively. TEAEs leading to discontinuation in participants treated with atogepant 10 mg, 30 mg, and 60 mg were reported by 4.1%, 1.8%, and 2.6% of participants, respectively, versus 2.7% of placebo-treated participants. The NNH was 73.0 for atogepant 10 mg. In the atogepant 30 mg and 60 mg dose groups, a lower percentage of participants discontinued versus placebo, resulting in negative NNT calculations (−105.5 and −949.7, respectively).
These findings show a positive benefit-risk profile with atogepant for the preventive treatment of EM.
Authors/Disclosures
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University)
PRESENTER 		Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch Health. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert for CME activities with Medscape/WebMD. Dr. Nahas has a non-compensated relationship as a Board Member-at-Large with American Headache Society that is relevant to AAN interests or activities. Dr. Nahas has a non-compensated relationship as a Executive Board Member with The Headache Alliance that is relevant to AAN interests or activities.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Rashmi B. Halker Singh, MD, FAAN (Mayo Clinic) 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.
No disclosure on file
Pranav Gandhi Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc.
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
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.