Abstract Details

Title Early Onset of Response to Fremanezumab in Migraine Patients With 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

Topic Headache

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

Poster/Presentation
Number 7-009

Objective A post hoc subgroup analysis evaluated early efficacy in patients with moderate to severe depression (Patient Health Questionnaire [PHQ-9] score ≥10).

Background

Fremanezumab is a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP). The FOCUS study of fremanezumab was the first and largest study of a migraine preventive treatment in adults with both chronic migraine (CM) and episodic migraine (EM) and documented inadequate response to 2-4 classes of migraine preventive medications.

Design/Methods

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 weekly migraine and headache days were evaluated during Weeks 1-3.

Results Of 838 randomized patients, 154 had moderate to severe depression at baseline. Reductions from baseline in weekly migraine days were significantly greater with fremanezumab (LSM[SE] change: quarterly, −0.9[0.29]; monthly, −0.6[0.30]) versus placebo (0.3[0.33]) by Week 1 and at each weekly time point through Week 3 (all P<0.05). Reductions from baseline in weekly headache days of at least moderate severity were significantly greater with fremanezumab (quarterly, −1.1[0.32]; monthly, −0.9[0.33]) versus placebo (0.0[0.36]) by Week 1 and at each weekly time point through Week 3 (all P<0.05).

Conclusions

Fremanezumab demonstrated early onset of efficacy in patients who would traditionally be considered difficult to manage in that they had failed on 2-4 migraine preventive medications and also had moderate to severe depression. Significantly greater reductions from baseline in weekly migraine and headache days were achieved as early as Week 1 with fremanezumab versus placebo.

Authors/Disclosures
Andrew M. Blumenfeld, MD, F�鶹��ýӳ�� (Cedars Sinai) PRESENTER	Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.
Ronghua Yang, PhD (Teva Pharmaceutical)	No disclosure on file
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.
Patricia Pozo-Rosich, MD, PhD	Dr. Pozo-Rosich has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pozo-Rosich has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Organon. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr. Reddy's. Dr. Pozo-Rosich has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sociedad Española Neurologia.

�鶹��ýӳ��

�鶹��ýӳ��