Abstract Details

Title Very Early Onset of Action of Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications: Results of the International, Multicenter, Randomized, Placebo-controlled FOCUS Study

Topic Headache

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-005

Objective Early onset of fremanezumab efficacy within the first week of study treatment was evaluated in this post hoc analysis.

Background Preventive treatments for episodic migraine (EM) and chronic migraine (CM) have been associated with slow onset of action. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) selectively targeting calcitonin gene-related peptide (CGRP), has proven efficacious for preventive migraine treatment in adults. The FOCUS study of fremanezumab was the first and largest study of a migraine preventive treatment in adults either with CM or EM having a previously documented inadequate response to 2-4 classes of migraine preventive medications.

Design/Methods Patients were randomized (1:1:1) to quarterly fremanezumab (Month 1: 675mg; Months 2 and 3: placebo), monthly fremanezumab (Month 1: CM, 675mg; EM, 225mg; Months 2 and 3: 225mg), or matched monthly placebo for 12 weeks. Proportions of patients with migraine days during the first 7 days of treatment were evaluated in the overall population and patients with CM.

Results 838 patients were randomized. Significantly fewer patients in the overall population had a migraine day with fremanezumab (quarterly, 32%; monthly, 36%) vs placebo (46%) on Day 2 and on each day through Day 7 (all P£0.011). In patients with CM (n=509), significantly fewer patients had a migraine day with fremanezumab (quarterly, 41%; monthly, 43%) vs placebo (57%) on Day 2 and on each day through Day 7 (all P<0.05).

Conclusions Fremanezumab demonstrated very early onset of action, with a larger proportion of patients reporting no migraine attacks within 24 hours and that difference persisted daily through Day 7 vs placebo. Fremanezumab showed very early onset of action in migraine patients, whether chronic or episodic, with a history of documented inadequate response to 2-4 classes of migraine preventive medications.

Authors/Disclosures
Jan L. Brandes, MD (Nashville Neuroscience Group, P.C.) PRESENTER	Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Brandes 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. Brandes has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Amgen. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Lewis Thomason. Dr. Brandes has received research support from Amgen. Dr. Brandes has received research support from Teva. Dr. Brandes has received research support from Allergan. Dr. Brandes has received research support from Biohaven. Dr. Brandes has a non-compensated relationship as a Board Member with National Headache Foundation that is relevant to �鶹��ýӳ�� interests or activities.
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
Joshua M. Cohen, MD	No disclosure on file
Maja Galic	Maja Galic has received personal compensation for serving as an employee of Teva.
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.
Christina Treppendahl (The Headache Center)	No disclosure on file

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