Abstract Details

Title Eptinezumab Demonstrated Early and Sustained Reductions in HIT-6 Total and Item Scores Over Time in Patients with Chronic Migraine in the PROMISE-2 Trial

Topic Headache

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-007

Objective To describe the effect of eptinezumab on short-form Headache Impact Test (HIT-6) total and item scores in patients with chronic migraine (CM).

Background The humanized anti-calcitonin gene-related peptide monoclonal antibody eptinezumab significantly reduced migraine frequency, sustained through 2 dosing intervals versus placebo, in patients with CM in the randomized, double-blind PROMISE-2 study (NCT02974153).

Design/Methods Patients received eptinezumab 100mg (n=356), 300mg (n=350), or placebo (n=366) for 2 intravenous doses administered every 12 weeks. Patients rated headache impact using the HIT-6 at baseline and Weeks 4, 12, 16, 24, and 32. HIT-6 total scores ranged from 36-78 with greater scores indicative of greater life impact. HIT-6 items were scored as 1=never, 2=rarely, 3=sometimes, 4=very often, and 5=always. Post hoc two-piece, linear mixed-effects modeling was used to examine longitudinal changes from baseline.

Results

Baseline headache impairment was similar across treatment groups. HIT-6 total scores decreased from baseline to Week 4 in all 3 groups (p<0.0001); reductions in eptinezumab groups were significantly greater versus placebo (p<0.0001). From Week 4 to 32, all groups demonstrated stable HIT-6 total scores. At all post-baseline time points, mean HIT-6 total scores were lower in eptinezumab groups versus placebo (p<0.05).

Scores for all individual items declined from baseline to Week 4 in all treatment groups; reductions in eptinezumab groups were significantly greater versus placebo (p<0.01). For all groups, HIT-6 item scores were generally stable from Week 4 to 32. Relative to placebo, impact levels were significantly lower from Week 4 to Week 32 for all 6 items with eptinezumab 300mg (p<0.01). Eptinezumab 100mg was significantly lower than placebo from Week 4 to Week 28 for 4 items and from Week 4 to Week 32 for 2 items (p<0.05).

Conclusions Eptinezumab reduced headache impact over the first month following intravenous administration, and benefits were sustained through 32 weeks.

Authors/Disclosures
RJ Wirth, PhD (Vector Psychometric Group, LLC) PRESENTER	RJ Wirth has received personal compensation for serving as an employee of Vector Psychometric Group, LLC.
James McGinley	James McGinley has received personal compensation for serving as an employee of Vector Psychometric Group, LLC. An immediate family member of James McGinley has received personal compensation for serving as an employee of UPMC Children's Community Pediatrics. James McGinley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for McGinley Statistical Consulting, LLC. James McGinley 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 SAGE Cephalalgia (journal). James McGinley has stock in various companies. The institution of James McGinley has received research support from National Headache Foundation.
Carrie R. Houts	Carrie R. Houts has received personal compensation for serving as an employee of Vector Psychometric Group, LLC.
	No disclosure on file
Roger Cady, MD (RK Consulting, LLC)	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	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 as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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 or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had 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.

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