Abstract Details

Title Long-Term Efficacy of Fremanezumab in Patients With Chronic Migraine and Comorbid Moderate to Severe Depression

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-024

Objective

Evaluate the long-term efficacy of fremanezumab on migraine frequency and depression in adults with chronic migraine (CM) and comorbid moderate to severe depression.

Background Patients with CM and comorbid depression have impaired quality of life, and treatments have been postulated to be less effective in these patients. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved in the US for the preventive treatment of migraine.

Design/Methods In this 52-week, multicenter, randomized, double-blind, parallel-group study, CM patients received subcutaneous fremanezumab either monthly (225 mg every month; starting dose of 675 mg) or quarterly (675 mg every 3 months). In the subgroup of patients with moderate to severe depression (score of ≥10 on the 9-item Patient Health Questionnaire [PHQ-9]) at baseline, post hoc analyses assessed changes from baseline in monthly average number of headache days of at least moderate severity, monthly number of migraine days, and PHQ-9 scores.

Results Approximately 21% (229/1103) of CM patients in the study had moderate to severe depression at baseline (quarterly, N=104; monthly, N=125). The change from baseline (mean ± standard deviation) in monthly average number of headache days of at least moderate severity was –5.6±6.6 with quarterly and –6.7±5.3 with monthly dosing at Month 6; changes were sustained at Month 12 (quarterly: –6.3±6.4; monthly: –7.0±5.7). The mean change from baseline in monthly average number of migraine days at Month 6 was –6.5±7.0 for quarterly and –8.2±6.5 for monthly dosing; changes were sustained at Month 12 (quarterly: –7.2±7.4; monthly: –8.6±6.7). Fremanezumab also reduced the mean PHQ-9 score from baseline (quarterly: 14.7±3.9; monthly: 14.7±3.5) to Month 6 (quarterly: 4.4±6.0; monthly: 3.9±6.1) and to Month 12 (quarterly: 4.2±6.1; monthly: 4.4±6.1).

Conclusions Fremanezumab demonstrated long-term efficacy in CM patients and comorbid moderate to severe depression and was associated with improvement in depression.

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 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.
Joshua M. Cohen, MD	No disclosure on file
Paul P. Yeung, MD, PhD	No disclosure on file
	No disclosure on file
Xiaoping Ning (Teva pharmaceuticals)	Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
Dawn C. Buse, PhD (Dawn C. Buse, PhD)	Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranicsa. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse 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 Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.

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