Abstract Details

Title Responder Rates With Eptinezumab Over 24 Weeks in Patients With Prior Migraine Preventive Treatment Failures

Topic Headache

Presentation(s) S47 - Advances in Migraine Therapeutics (2:12 PM-2:24 PM)

Poster/Presentation
Number 007

Background Eptinezumab is an intravenous anti-calcitonin gene-related peptide monoclonal antibody approved for preventive treatment of migraine. In the DELIVER study, eptinezumab treatment resulted in greater reductions than placebo in monthly migraine days (MMDs).

Objective To report the consistency of response to eptinezumab and potential for response in initial non-responders in patients with prior preventive treatment failures.

Design/Methods DELIVER (NCT04418765) randomized adults with episodic or chronic migraine and 2-4 prior preventive treatment failures to infusion with eptinezumab 100mg, 300mg, or placebo every 12 weeks. Migraine responder rates (MRRs) of ≥30%, ≥50%, and ≥75% over Weeks 1-12 and 13-24, MRRs over 4-week intervals, and the percentage of initial non-responders (Weeks 1-12) achieving response to their second infusion (Weeks 13-24) were calculated. MRRs are calculated as an average percentage change from baseline in MMDs over the specified interval.

Results The full analysis set included 890 patients (100mg, n=299; 300mg, n=293; placebo, n=298). Between Weeks 1-12 and 13-24, respectively, ≥30% MRRs increased from 65.9% to 70.4% (100mg), from 71.0% to 74.5% (300mg), versus 36.9% to 43.1% (placebo; P<0. 0001 for both doses/timepoints vs placebo). The ≥30%, ≥50%, and ≥75% MRRs were generally maintained or further increased over the 24-week period, with further numerical increases in responder rates observed after the second eptinezumab infusion. Across treatment groups, response over Weeks 1-12 was generally maintained over Weeks 13-24; however, of patients with <30% response over Weeks 1-12, 34.7% (100mg), 30.4% (300mg), vs 21.1% (placebo) achieved ≥30% response over Weeks 13-24, and 16.8% (100mg), 15.2% (300mg), vs 6.5% (placebo) achieved ≥50% response.

Conclusions Across MRR thresholds, most patients who responded to eptinezumab during Weeks 1-12 maintained response during Weeks 13-24, with responder rates further increasing from the first to the second infusion. Approximately one-third of initial non-responders became responders after their second infusion.

Authors/Disclosures
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) PRESENTER	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 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 stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has 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.
Messoud Ashina, MD, PhD (Dept. of Neurology)	Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)	Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 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 $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 GlaxoSmithKline. 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 $5,000-$9,999 for serving as a Consultant for Gore. 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 $500-$4,999 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 Theranica. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scilex. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eneura. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani 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. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Linpharma. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Report. 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 Medscape. The institution of Dr. Ailani has received research support from Satsuma. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Medical Advisor with SELF.
Jan Versijpt	Jan Versijpt has nothing to disclose.
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.
Dimos Dimitrios D. Mitsikostas, MD, PhD (National and Kapodistrian University of Athens)	The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Mitsikostas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Leli Lilly. The institution of Dr. Mitsikostas has received research support from Eli Lilly. Dr. Mitsikostas has a non-compensated relationship as a Co-Chair of Headache Panel with EAN that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a President with Hellenic Headache Society that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a Associate Editor with J Headache Pain that is relevant to AAN interests or activities. Dr. Mitsikostas has a non-compensated relationship as a Associate Editor with Frontier Neurology that is relevant to AAN interests or activities.
	No disclosure on file
Bjoern Sperling (H Lundbeck A/S)	Bjoern Sperling has received personal compensation for serving as an employee of Lundbeck . Bjoern Sperling has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Rehaler . Bjoern Sperling has stock in Lundbeck .
Anders Ettrup (H. Lundbeck A/S)	Anders Ettrup has received personal compensation for serving as an employee of H. Lundbeck A/S.