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Abstract Details

Efficacy With Fremanezumab in Migraine Patients With Comorbid Moderate to Severe Depression and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Treatments: Subgroup Analysis of the Randomized, Placebo-controlled FOCUS Study
Headache
P7 - Poster Session 7 (5:30 PM-6:30 PM)
7-001
A post hoc subgroup analysis evaluated efficacy of fremanezumab in patients with comorbid moderate to severe depression (Patient Health Questionnaire-9 score ≥10) with inadequate response to 2-4 classes of migraine preventive medications.
The FOCUS study of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets the calcitonin gene-related peptide (CGRP), was the first and largest study of a migraine preventive treatment in adults with either chronic migraine (CM) or episodic migraine (EM) and documented inadequate response to 2-4 classes of migraine preventive medications.
Patients were randomized (1:1:1) to quarterly fremanezumab (Month 1: 675 mg; Months 2 and 3: placebo), monthly fremanezumab (Month 1: CM, 675 mg; EM, 225 mg; Months 2 and 3: 225 mg), or matched monthly placebo for 12 weeks. Changes from baseline in monthly average migraine and headache days of at least moderate severity were evaluated in patients with moderate to severe depression. Patients with significant psychiatric issues (eg, major depression with increased risk of suicidality or schizophrenia) that, in the investigator’s opinion, would compromise the patient’s ability to participate in the study were excluded.
Of 838 randomized patients, 154 had moderate to severe depression and were included in these analyses. Reductions from baseline in monthly average migraine days were significantly greater with fremanezumab versus placebo at 4 weeks (least-squares mean [SE] change: quarterly, −3.5[0.91]; monthly, −3.5[0.95] vs 0.9[1.03]; P<0.001) and 12 weeks (quarterly, −3.2[0.93]; monthly, −3.9[0.97] vs 0.2[1.05]; P<0.01). Reductions from baseline in monthly average headache days were significantly greater with fremanezumab versus placebo at 4 weeks (quarterly, −4.5[1.01]; monthly, −4.5[1.07] vs −0.1[1.16]; P≤0.001) and 12 weeks (quarterly, −4.3[1.01]; monthly, −4.7[1.06] vs −0.8[1.15]; P<0.01).
Fremanezumab demonstrated efficacy, based on reductions in monthly migraine and headache days, versus placebo in patients with migraine, moderate to severe depression, and inadequate response to 2-4 classes of migraine preventive medications.
Authors/Disclosures
Dawn C. Buse, PhD (Dawn C. Buse, PhD)
PRESENTER 		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.
Joshua M. Cohen, MD No disclosure on file
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Ronghua Yang, PhD (Teva Pharmaceutical) 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.
Maja Galic Maja Galic has received personal compensation for serving as an employee of Teva.
Richard B. Lipton, MD, FÂ鶹´«Ã½Ó³»­ (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.