Abstract Details

Title Clinically Meaningful Responses to Fremanezumab in Migraine Patients with Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medications in the Randomized, Placebo-controlled FOCUS Study

Topic Headache

Presentation(s) S58 - Headache Therapeutics (1:00 PM-1:12 PM)

Poster/Presentation
Number 001

Objective We aimed to evaluate responder rates in a subgroup of patients with medication overuse (use of any acute medication on ≥15 days/month or triptans/ergots/combination medications on ≥10 days/month) at baseline.

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 episodic or chronic migraine (EM or CM) and documented inadequate response to 2-4 classes of migraine preventive medications.

Design/Methods For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab (Months 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (Months 1/2/3: 225mg[EM],675mg [CM]/225mg/225mg), or matched monthly placebo. Proportions of patients with ≥50% and ≥75% reductions from baseline in monthly average migraine days at 4 weeks and during 12 weeks were compared using logistic regression.

Results Of 838 randomized patients, 435 had medication overuse. During 12 weeks of double-blind treatment, a significantly greater proportion of patients achieved ≥50% reduction in monthly migraine days with quarterly (25%) and monthly (33%) fremanezumab versus placebo (7%; P≤0.0001). A significantly greater proportion of patients also achieved ≥75% reduction in monthly migraine days with monthly fremanezumab (11%) versus placebo (1%; P=0.0040) during 12 weeks of treatment; differences between quarterly fremanezumab (5%) and placebo were not statistically significant. At 4 weeks, a significantly greater proportion of patients achieved ≥50% and ≥75% reduction in monthly migraine days with both fremanezumab dosing regimen versus placebo (P<0.05).

Conclusions In migraine patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive medication classes, significantly more patients treated with fremanezumab achieved ≥50% and 75% reductions in migraine days versus placebo. Fremanezumab provided early and sustained clinically meaningful results in this subgroup, suggesting medication overuse is not an impediment to effective preventive treatment with this antibody.

Authors/Disclosures
Sait Ashina, MD (Beth Israel Deaconess Medical Center, Harvard Medical School) PRESENTER	Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer.
Verena Ramirez Campos, MD (Teva)	Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
Joshua M. Cohen, MD	No disclosure on file
	No disclosure on file
Egilius L. Spierings, MD, PhD (MEDVADIS RESEARCH)	Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Manistee. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.

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