Abstract Details

Title Safety, Tolerability, and Efficacy of Atogepant Added to OnabotulinumtoxinA for the Preventive Treatment of Chronic Migraine: A Phase 3, Multicenter, 24-week, Open-label Study

Topic Headache

Presentation(s) P10 - Poster Session 10 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-010

Objective Evaluate the safety, tolerability, and efficacy of adding atogepant to onabotulinumtoxinA (onabotA) for the preventive treatment of chronic migraine (CM).

Background Despite recent advances in therapeutic management of CM, data on combination therapy is limited.

Design/Methods In this 24-week, Phase 3, open-label, multicenter study (NCT05216263), 75 participants on a stable dose of onabotA (155-200U) received add-on atogepant 60mg once daily. Primary safety endpoints included treatment-emergent adverse events (TEAEs), and efficacy assessments included changes in mean monthly migraine days (MMDs), and responder rates (RR) (≥50% and ≥75% MMDs) over weeks 1-12 and 13-24.

Results Participant mean age was 48 years; 89% were women, and 97% were white. Participants had an established CM diagnosis for 15 (13.27) years (mean (SD)) and had been treated with onabotA for 4 (3.45) years (mean (SD)). In the safety population (n = 75), the incidence of TEAEs was 65.3%. TEAEs occurring in ≥5% of patients were constipation (n=12, 16.0%), nausea (n=10, 13.3%), and urinary tract infection (n=6, 8.0%). Treatment-emergent serious AEs occurred in 2 participants, neither considered treatment-related by the investigators. In the modified intention-to-treat population (n = 72), the change from baseline of 14.34 MMDs was -6.45 MMDs [95% CI: -7.72, -5.19] across weeks 1-4, -6.89 MMDs [95% CI: −8.15, −5.62] across weeks 1-12 and −7.20 MMDs [95% CI: −8.49, -5.91] across weeks 13-24 (least square means). A ≥50% RR was achieved by 54.2% and 61.9% of participants, across weeks 1-12 and weeks 13-24 of combined treatment, respectively. A ≥75% RR was achieved by 30.6% and 38.1% participants, respectively.

Conclusions Combination management with onabotA and atogepant for CM appears to be safe and generally well-tolerated. Adding atogepant to onabotA resulted in clinically meaningful reductions in migraine days and improvement in RR, reflecting the potential benefit of utilizing combination therapy with distinct but complementary mechanisms of action for CM management.

Authors/Disclosures
John F. Rothrock, MD (Inova Health) PRESENTER	Dr. Rothrock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Rothrock has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for AbbVie. Dr. Rothrock has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. The institution of Dr. Rothrock has received research support from AbbVie. The institution of Dr. Rothrock has received research support from Ipsen. The institution of Dr. Rothrock has received research support from Lundbeck.
Umer Najib, MD, FAAN (West Virginia University Hospitals)	Dr. Najib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Najib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck . Dr. Najib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie . The institution of Dr. Najib has received research support from Eli Lilly. The institution of Dr. Najib has received research support from Abbvie.
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.
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.
Jia Bao, PhD	Dr. Bao has received personal compensation for serving as an employee of AbbVie. Dr. Bao has stock in AbbVie.
Jonathan H. Smith, MD (AbbVie)	Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
Iryna Shakhmantsir (Abbvie)	Dr. Shakhmantsir has received personal compensation for serving as an employee of 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.
Kimberly Pfleeger	Ms. Pfleeger has received personal compensation for serving as an employee of AbbVie. Ms. Pfleeger has stock in AbbVie.
Andrew M. Blumenfeld, MD, FAAN (Cedars Sinai)	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/Abbvie. 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 $50,000-$99,999 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 $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. 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/Abbvie. 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 $10,000-$49,999 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/Abbvie. 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 $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.

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