Real-world Evidence of Adding Atogepant to OnabotulinumtoxinA for Control of Chronic Migraine: A Retrospective Chart Review (P4-12.001).

To collect real-world data to evaluate the effectiveness, safety, and tolerability of adding atogepant to onabotulinumtoxinA as combination preventive treatment for chronic migraine (CM). Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of CM. This retrospective, longitudinal, multi-center chart review included adults with CM receiving ≥2 consecutive onabotulinumtoxinA cycles before ≥3mo of onabotulinumtoxinA and atogepant combination treatment. Charts at first atogepant prescription (index date) and 2 onabotulinumtoxinA injection visits (~3 and 6mo post-index) were reviewed for change from baseline in monthly headache days (MHDs), ≥50% reduction in MHDs, and rates and types of adverse events (AEs). Charts with CGRP agents for migraine prevention during baseline (~3mo pre-index) were excluded. 31 charts met eligibility criteria (mean age 46.7 years, 94% female). Atogepant 60 mg and 30 mg were administered QD to 30 and 1 patients, respectively. Throughout the study, patients received a mean dose of 170U onabotulinumtoxinA. Pre-onabotulinumtoxinA, the mean MHD was 24.0d, reduced by a mean -8.15d (95%CI -11.44,-4.85; n=25) after onabotulinumtoxinA pre-index (mean 3.97yr). MHD additionally decreased by mean -4.53d [95%CI -7.44,-1.61] after ~3mo of combination treatment (n=31) and -8.75d total [95%CI -13.21, -4.29] after ~6mo of combination treatment in patients with data available (n=23). Nearly half of patients (n=14/31) achieved ≥50% reduction in MHDs ~3mo post-index. Overall, 95% CIs indicate that reductions from baseline were statistically significant. No new safety signals were identified when atogepant was added to onabotulinumtoxinA. The most commonly reported AEs (≥5%) were constipation and fatigue. This real-world pilot study of patients with CM demonstrated clinically meaningful treatment benefit in the reduction of headache days with onabotulinumtoxinA alone and additive benefits with co-administration of atogepant. Safety results were consistent with the known safety profiles of onabotulinumtoxinA and atogepant. Disclosure: 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 $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. Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Jushi Inc. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Mechtler has received stock or an ownership interest from Jushi Co.. The institution of Dr. Mechtler has received research support from The Harry Dent Family Foundation, Inc. The institution of Dr. Mechtler has received research support from Amgen/Novartis. The institution of Dr. Mechtler has received research support from Alder/ Lundbeck. The institution of Dr. Mechtler has received research support from Abbvie/Allergan. The institution of Dr. Mechtler has received research support from Miles for Migraine. The institution of Dr. Mechtler has received research support from American Migraine Foundation. The institution of Dr. Mechtler has received research support from Charlotte's Web. Dr. Cook has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Cook has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Cook has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel. The institution of Dr. Cook has received research support from Abbvie . The institution of Dr. Cook has received research support from Aeon. The institution of Dr. Cook has received research support from Axsome . The institution of Dr. Cook has received research support from Lilly . Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie/Allergan. Dr. Rhyne 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. Rhyne has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Rhyne has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Rhyne has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lilly. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Theranica. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Rhyne has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with Diamond Headache Clinic Research and Education Foundation. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving as a Speaker with National Headache Foundation. Dr. Jenkins has received personal compensation for serving as an employee of Abbvie. Dr. Jenkins has received personal compensation for serving as an employee of Allergan. Dr. Jenkins has received personal compensation for serving as an employee of Teva. Dr. Jenkins has received personal compensation for serving as an employee of Biohaven. Dr. Jenkins has received personal compensation for serving as an employee of Lundbeck . Dr. Jenkins has received personal compensation for serving as an employee of Amgen and Novartis. Dr. Jenkins has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Jenkins has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan . Dr. Jenkins has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Jenkins has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven . Dr. Jenkins has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Dr. Jenkins has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen and Novartis. Dr. Jenkins has stock in Prevacus. Dr. Jenkins has received intellectual property interests from a discovery or technology relating to health care. Ms. Hughes has received personal compensation for serving as an employee of ICON plc. Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie. Dr. Manack Adams has received personal compensation for serving as an employee of Abbvie. Dr. Manack Adams has stock in Abbvie. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan/AbbVie . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck Pharmaceutical . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel NeuroPharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Promius. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck Pharmaceuticals . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/AbbVie. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Assertio. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Promius Pharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Supernus . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva Pharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Upsher-Smith . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel Neuro Pharma . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Assertio. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axsome Pharma . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Assertio Therapeutics . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus Pharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva . Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Upsher Smith. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Impel Neuro Pharma. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan/AbbVie. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Lundbeck . Merle Diamond has received research support from Amgen . Merle Diamond has received research support from Lundbeck. Merle Diamond has received research support from Teva . Merle Diamond has received research support from Eli Lilly. Merle Diamond has received research support from Allergan. Merle Diamond has received personal compensation in the range of $500-$4,999 for serving as a Course Directory, Speaker with Diamond Research & Educational Foundation.