Abstract Details

Title Efficacy of Fremanezumab in Migraine Patients with Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medication Classes: 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 7-002

Objective To evaluate efficacy in a subgroup of patients with baseline medication overuse (use of any acute medication on ≥15 days/month or triptans/ergots/combination medications on ≥10 days/month).

Background The FOCUS study of fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), 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: 675mg; Month 2 and 3: placebo), monthly fremanezumab (Month 1: CM, 675mg; EM, 225mg; Months 2 and 3: 225mg), or matched monthly placebo for 12 weeks. Changes from baseline in monthly migraine days and headache days of at least moderate severity at 4 weeks and during 12 weeks of treatment were compared using a mixed-effect model for repeated measures.

Results Of 838 randomized patients, 435 had baseline medication overuse. Reductions from baseline in monthly average migraine days were significantly greater with quarterly fremanezumab (least-squares mean [SE] change, −3.3 [0.61]) and monthly fremanezumab (−4.6 [0.55]) versus placebo (−0.5, [0.62]; both P≤0.0001) during 12 weeks of treatment. Reductions from baseline in monthly average headache days of at least moderate severity were also significantly greater with quarterly fremanezumab (least-squares mean [SE] change, −4.0 [0.61]) and monthly fremanezumab (−5.1 [0.54]) versus placebo (−0.8, [0.61]; both P<0.0001) during 12 weeks of treatment. At 4 weeks of double-blind treatment, changes from baseline in monthly average migraine days and headache days of at least moderate severity were also significantly greater with fremanezumab versus placebo (all P<0.0001).

Conclusions Quarterly and monthly fremanezumab provided early and sustained reductions in migraine and headache days versus placebo in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive medications.

Authors/Disclosures
Stephen D. Silberstein, MD, F�鶹��ýӳ�� PRESENTER	Dr. Silberstein has received publishing royalties from a publication relating to health care.
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
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.
Adelene Jann, MD (NYU Langone Health)	Dr. Jann has nothing to disclose.

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