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Abstract Details

Efficacy in Patients Switching from Quarterly to Monthly Fremanezumab or Maintained on Monthly Fremanezumab Treatment Over 6 Months in the Phase 3b FOCUS Study
Headache
Headache Posters (7:00 AM-5:00 PM)
007

Fremanezumab is a fully humanized monoclonal antibody (IgGΔa) that selectively targets calcitonin gene-related peptide (CGRP) and has proven efficacy for the preventive treatment of migraine in adults.

To assess efficacy in patients who switched from quarterly fremanezumab during the double-blind period (DBP) to monthly fremanezumab (switch subgroup) in the open-label extension (OLE) and in patients who received monthly fremanezumab (maintenance subgroup) throughout the DBP and OLE in the FOCUS study.

FOCUS included a 12-week DBP and 12-week OLE. Patients were initially randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or matched placebo for the DBP. All patients completing the DBP entered the OLE and received monthly fremanezumab (three 225-mg doses). Efficacy measures during OLE were summarized by DB randomization group.

Of 838 patients randomized, 807 completed the DBP and entered the OLE: 271 were in the switch subgroup and 272 in the maintenance subgroup. For patients in the switch and maintenance subgroups, respectively, comparable mean changes from baseline during the OLE were observed in monthly average migraine days (−5.1 and −5.5), headache days of at least moderate severity (−4.8 and −5.2), and days of any acute headache medication use (−4.9 and −4.8). The proportion of patients who achieved ≥50% reduction from baseline in monthly average migraine days during the OLE was also comparable in the switch (45%) and maintenance (46%) subgroups. During the OLE, mean changes from baseline in disability outcomes were also similar for patients in the switch and maintenance subgroups, respectively, including the 6-item Headache Impact Test (−8.4 and −8.3) and Migraine Disability Assessment (−29.9 and −33.9).

Efficacy was comparable in patients switching from quarterly to monthly fremanezumab during the OLE and those maintained on monthly dosing throughout the DBP and OLE.

Authors/Disclosures
Jonathan P. Gladstone, MD
PRESENTER
Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lily. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lily. Dr. Gladstone has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aralez. Dr. Gladstone has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Gladstone has received publishing royalties from a publication relating to health care.
H. Christoph Diener, MD, FAAN (University Duisburg-Essen) Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Diener has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Thieme. The institution of Dr. Diener has received research support from German Research Council.
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 *use 125685 Cohen (Teva Pharmaceuticals Industries) Joshua Cohen has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Verena *use 212969 Ramirez Campos (Teva Pharmaceuticals) Verena Ramirez Campos has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Evelyn Du (Teva Pharmaceuticals) Evelyn Du has received personal compensation for serving as an employee of Teva Pharmaceuticals.
Egilius L H 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.