Abstract Details

Title Exploratory Efficacy Results from the TANDEM Trial: Safety, Tolerability, and Efficacy of Ubrogepant for the Acute Treatment of Migraine in Participants Taking Atogepant for the Preventive Treatment of Episodic Migraine

Topic Headache

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-002

Objective Evaluate efficacy of ubrogepant 100mg PRN for the acute treatment of migraine in participants taking atogepant 60mg QD for the preventive treatment of EM.

Background Ubrogepant is approved in the US for acute treatment of migraine in adults, with/without aura.Atogepant is approved in the US and EU for preventive treatment of migraine in adults.

Design/Methods TANDEM,a US, phase 4,two-period,multicenter,open-label safety study,enrolled adults with migraine,with or without aura,and <15 headache days per month across 3 months.In Period 1(P1,Wks1–12),participants were treated with atogepant 60mg QD and their own acute medication,excluding any gepant,for breakthrough migraine attacks.In P2(Wks13–24), participants continued atogepant 60mg QD and used ubrogepant 100mg PRN for breakthrough migraine attacks.In P2,a second ubrogepant dose,or the participants’ own acute medication,was allowed 2–24hrs after the initial ubrogepant dose.Safety was evaluated and treatment-emergent adverse events(TEAEs) were defined as AEs with an onset date ≥date study treatment first dose but <30 days after last dose or Visit 8/Wk24.All efficacy endpoints in this study were exploratory.This analysis evaluated the efficacy of ubrogepant 100mg PRN in P2.During P2 (Wk16,20,24),a structured Investigator Interviewer Questionnaire(IIQ) assessed ubrogepant dosing,pain freedom,and pain relief while the MTOQ-6 assessed treatment optimization.

Results P2 included 211 participants who were treated,had a baseline efficacy assessment,and had ≥1 post-baseline efficacy assessment (mITT population 2).During P2,mean monthly ubrogepant use days over Wks13–24 was 2.13 days (SD,1.86).Monthly and 12-wk mean response rates for pain freedom and relief at 2hrs and sustained pain freedom and relief from 2–24hrs consistently exceeded 50% for breakthrough migraine attacks treated with ubrogepant during P2.Mean MTOQ-6 scores(SD) were 21.7(3.4),22.2(2.9),and 22.4(2.8) during Wks16,20,and 24,respectively.The overall safety results were consistent with the known safety profile of atogepant and ubrogepant.

Conclusions Ubrogepant-treated participants recalled high rates of pain freedom and relief,and high treatment optimization when used concomitantly with atogepant 60mg QD.No new safety signals were identified.

Authors/Disclosures
Nicole Naccara (Abbvie) PRESENTER	Dr. Naccara has received personal compensation for serving as an employee of Abbvie . Dr. Naccara 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.
Molly He	Molly He has nothing to disclose.
Jonathan H. Smith, MD (AbbVie)	Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
Casey Schlacher, RN	Ms. Schlacher has received personal compensation for serving as an employee of AbbVie. Ms. Schlacher has stock in AbbVie.
Janette Contreras-De Lama	Janette Contreras-De Lama has received personal compensation for serving as an employee of AbbVie. Janette Contreras-De Lama has stock in AbbVie.
Linda Davis, MD	Dr. Davis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Davis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly . Dr. Davis has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Davis has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Davis has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly.

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