Abstract Details

Title Patient Global Impression of Change Related to Improvement in Most Bothersome Symptom Following Treatment With Eptinezumab

Topic Headache

Presentation(s) S38 - Headache: Clinical Trials II (2:28 PM-2:39 PM)

Poster/Presentation
Number 009

Background Eptinezumab, a selective and potent anti-CGRP monoclonal antibody, demonstrated significant migraine reduction and acceptable safety in PROMISE-2, a phase 3 clinical trial of CM (NCT02974153).

Objective To evaluate the impact of eptinezumab treatment on patient global impression of change (PGIC) and self-reported most bothersome associated symptom (MBAS) in patients with chronic migraine (CM).

Design/Methods Adults with CM were randomized to eptinezumab 100mg, 300mg, or placebo, administered intravenously every 12 weeks (wks) for 2 infusions. Patients identified their MBAS associated with migraines at screening. MBAS options included physical, sensory, autonomic, and psychological symptoms from prodrome through postdrome. PGIC and improvement in the identified MBAS were assessed at 4-wk intervals using a 7-point rating scale (from “very much improved” to “very much worse”).

Results The efficacy population included 1072 patients (100mg, n=356; 300mg, n=350; placebo, n=366). Eptinezumab 100mg and 300mg resulted in statistically significant reductions in mean monthly migraine days vs placebo (p<0.0001, both doses). Most frequently identified MBASs were light sensitivity, pain with activity, and nausea. At Wk4, MBAS was much or very much improved in 45.0% (100mg), 56.9% (300mg), and 28.9% (placebo) of patients, and PGIC was much or very much improved in 45.0%, 59.0%, and 32.3%, respectively. MBAS was minimally improved in 30.1% (100mg), 22.2% (300mg), and 29.7% (placebo) of patients, with PGIC minimally improved in 31.6%, 22.3%, and 24.0%, respectively. MBAS was rated as not changed to very much worse in 24.9% (100mg), 21.0% (300mg), and 41.4% (placebo) of patients, and PGIC was rated as not changed to very much worse in 23.4%, 18.8%, and 43.6%, respectively. Ratings of improvement were maintained or further improved at Wk12 and Wk24.

Conclusions Eptinezumab improved MBAS beginning by Month 1, maintained through 2 quarterly infusions. Trends in MBAS improvement and PGIC were similar across time points, suggesting improvements in MBAS are highly correlated with PGIC.

Authors/Disclosures
Roger Cady, MD (RK Consulting, LLC) PRESENTER	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
Lora McGill, MD, FAAN (CNS Healthcare)	No disclosure on file
	No disclosure on file
David M. Biondi, DO, FAAN	Dr. Biondi has received personal compensation for serving as an employee of Cohen Veterans Bioscience, Inc. Dr. Biondi has received personal compensation for serving as an employee of Alder Biopharmaceuticals, Inc. Dr. Biondi has received stock or an ownership interest from Johnson & Johnson . The institution of Dr. Biondi has received research support from US Department of Defense .
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 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.

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