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Abstract Details

Benefit-Risk Assessment Based on Number Needed to Treat and Number Needed to Harm: Atogepant vs Calcitonin Gene–Related Peptide Monoclonal Antibodies
Headache
P5 - Poster Session 5 (5:30 PM-6:30 PM)
12-007
Evaluate the benefit-risk assessment of atogepant and calcitonin gene– related peptide (CGRP) monoclonal antibodies (mAbs) vs placebo based on number needed to treat (NNT) and number needed to harm (NNH) in a blended episodic and chronic migraine population (EM+CM).
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved in the U.S. for the preventive treatment of migraine in adults.
The NNT was calculated based on achievement of a ≥50% reduction in mean monthly migraine days (MMDs) from baseline across 12 weeks. A random effects model was used in the meta-analysis of trials to calculate the median ≥50% response rates, NNTs, and credible intervals (CrI) versus placebo at 12 weeks. The NNH was calculated using the proportion of participants reporting a discontinuation due to adverse events (AEs). A cloglog link model was used to estimate median discontinuation rates due to AEs at 12 weeks and calculate NNH and CrI. The base-case analysis included data from core studies of atogepant 60 mg, erenumab 70 mg and 140 mg, galcanezumab 120 mg, eptinezumab 100 mg and 300 mg, and fremanezumab 225 mg and 675 mg. Additional scenario analyses were conducted, including dose-response relationship studies, Asian studies, and dedicated inadequate prior treatment studies (only for NNH).
Based on the base-case scenario, the calculated NNT for atogepant 60 mg vs placebo was 4.2, which was comparable with CGRP mAbs in the blended EM+CM population. Participants who received atogepant 60 mg or fremanezumab (225 mg or 675 mg) demonstrated lower rates of discontinuation due to AEs compared with those receiving placebo, resulting in negative NNH values. Comparable NNT and NNH values were observed for atogepant 60 mg relative to the mAbs across all scenario analyses.
Atogepant demonstrated a favorable benefit-risk profile, with NNT and NNH values comparable with those of CGRP mAbs across all scenarios.
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.
Simona Sacco, MD (University of L'Aquila) Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Sacco has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lilly. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Prof. Sacco has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Prof. Sacco has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers in Neurology. The institution of Prof. Sacco has received research support from Novartis. Prof. Sacco has a non-compensated relationship as a President elect with European Stroke Organisation that is relevant to AAN interests or activities. Prof. Sacco has a non-compensated relationship as a Second vice President with European Headache Federation that is relevant to AAN interests or activities.
Anjana Lalla (Abbvie) Anjana Lalla has nothing to disclose.
Holle Lee Dagny (University Hospital Essen) 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 $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 Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Organon. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy's. 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.
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.
Kari Kelton (Medical Decision Modeling Inc.) Kari Kelton has nothing to disclose.
Cristiano Piron (Medical Decision Modeling) Cristiano Piron has received personal compensation for serving as an employee of Medical Decision Modeling Inc.
Pranav Gandhi Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc.
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.