Abstract Details

Title Impact of Fremanezumab on Migraine-associated Symptoms in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study

Topic Headache

Presentation(s) P6 - Poster Session 6 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-007

Objective To assess changes in migraine-related symptoms (nausea/vomiting and photophobia/phonophobia) with fremanezumab treatment during up to 6 months in patients with episodic and chronic migraine (EM and CM) and documented inadequate response to 2-4 classes of migraine preventive medications.

Background Non-headache migraine-related symptoms may be particularly disabling and are often rated the most bothersome symptom of migraine. The efficacy and tolerability of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP) and has been approved for the preventive treatment of migraine, have been shown for patients failing multiple prior migraine preventive medication classes in the double-blind period of the phase 3b FOCUS study.

Design/Methods The FOCUS study included both a 12-week, double-blind, placebo-controlled treatment period and 12-week, open-label treatment period. Patients were initially randomized (1:1:1) to quarterly fremanezumab (Month 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Month 1/2/3: 675mg[CM],225mg[EM]/225mg/225mg), or matched monthly placebo for a 12-week, double-blind period. All patients completing double-blind treatment entered the open-label period and received three monthly doses of fremanezumab (225mg). Changes in monthly days with nausea or vomiting and photophobia and phonophobia from baseline (assessed during 28-day run-in period before first double-blind dose) were evaluated during the open-label period and summarized by double-blind randomization group.

Results Of 838 patients randomized, 807 completed double-blind treatment and entered the open-label period. Reductions from baseline in monthly average days with nausea or vomiting during the 12-week open-label treatment period were observed in the placebo (−2.3[4.55]), quarterly fremanezumab (−3.1[4.46]), and monthly fremanezumab (−3.0[4.44]) groups. Reductions from baseline during the open-label treatment period were also observed in monthly average days with photophobia and phonophobia (−3.2[5.27], −3.4[5.27], and −4.0[5.19], respectively).

Conclusions Reductions in migraine-related symptoms were observed with up to 6 months of fremanezumab treatment in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive medications.

Authors/Disclosures
Laszlo Mechtler, MD, FEAN, FASN, FAHS, F�鶹��ýӳ�� (Dent Neurologic Institute) PRESENTER	Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharma. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Hyperfine. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Genomate Health. The institution of Dr. Mechtler has received research support from The Harry Dent Family Foundation, Inc. The institution of Dr. Mechtler has received research support from Alpheus medical. The institution of Dr. Mechtler has received research support from Shiratronics. The institution of Dr. Mechtler has received research support from Abbvie Inc. The institution of Dr. Mechtler has received research support from Amgen. The institution of Dr. Mechtler has received research support from Eli Lilly Company. The institution of Dr. Mechtler has received research support from H. Lundbeck HS. The institution of Dr. Mechtler has received research support from Pfizer. The institution of Dr. Mechtler has received research support from Hyperfine. Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Ownership interest with Neurology Practce Consortium GPO. Dr. Mechtler has a non-compensated relationship as a Board member with International Headache Society that is relevant to �鶹��ýӳ�� interests or activities.
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.
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

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