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Abstract Details

Efficacy of Fremanezumab in Male Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medication Classes: Results of the Randomized, Placebo-controlled FOCUS Study
Headache
P5 - Poster Session 5 (8:00 AM-9:00 AM)
7-006
Efficacy of fremanezumab was evaluated in a subgroup of male patients from the FOCUS study.
As migraine prevention studies enroll predominantly women due to the epidemiology, data on efficacy for migraine preventive treatments in male patients is lacking. The FOCUS study of fremanezumab was the first and largest study of a migraine preventive treatment in adults with both episodic migraine (EM) and chronic migraine (CM) and documented inadequate response to 2-4 classes of migraine preventive treatments.
Patients were randomized (1:1:1) to quarterly fremanezumab (Month 1: 675mg; Months 2 and 3: placebo), monthly fremanezumab (Month 1: EM, 225mg; CM, 675mg; Months 2 and 3: 225mg), or matched monthly placebo for 12 weeks. Changes from baseline in monthly average migraine days and headache days of at least moderate severity and proportions of patients achieving ≥50% reduction in monthly average migraine days over 12 weeks were evaluated for male patients.
Of 838 randomized patients, 138 were male. Reductions from baseline in monthly average migraine days were significantly greater with the fremanezumab groups (least-squares mean [SE] change: quarterly, −4.2 [0.73]; monthly, −4.6 [0.78]; both P<0.0001) vs placebo (−0.4 [0.74]) over 12 weeks. Reductions from baseline in monthly average headache days of at least moderate severity were also significantly greater with both fremanezumab groups (least-squares mean [SE] change: quarterly, −4.2 [0.75]; monthly, −4.5 [0.80]; both P<0.0001) vs placebo (−0.5 [0.74]) over 12 weeks. The proportions of patients who achieved ≥50% reduction in monthly average migraine days over 12 weeks of treatment were significantly higher with quarterly (30%) and monthly (38%) fremanezumab vs placebo (9%), both P<0.05.
This subgroup analysis demonstrated statistically significant improvements in efficacy outcomes due to the strong effect size vs placebo in male patients, a group for whom the impact of migraine is often underestimated and undertreated.
Authors/Disclosures

PRESENTER 		No disclosure on file
G.M. Terwindt (MSD BV B03) G.M. Terwindt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Teva, Allergan, Lilly, Lundbeck. The institution of G.M. Terwindt has received research support from Dutch Research Council, Dutch Brain Council, IRRF, Dioraphte.
Joshua M. Cohen, MD No disclosure on file
Ronghua Yang, PhD (Teva Pharmaceutical) No disclosure on file
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
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.
No disclosure on file