Fremanezumab results of the FOCUS study

The overall positive efficacy and safety/tolerability results of fremanezumab in the placebo-controlled FOCUS study were reported in different posters.

Participants had episodic or chronic migraine and inadequate response to 2-4 classes of migraine preventive medications. A total of 838 patients were randomised to monthly fremanezumab (month 1: chronic migraine, 675 mg & episodic migraine, 225 mg; months 2 and 3: 225 mg), quarterly fremanezumab (month 1: 675 mg; months 2 and 3: placebo), or matched monthly placebo. Reductions in monthly average migraine days, clinically meaningful response rates within 4 weeks, and sustained ≥50% response rates over 3 months were significantly greater with fremanezumab vs placebo (both P<0.0001; see Table) [1]. Higher proportions of patients achieved ≥50% and ≥75% reductions in migraine days within 4 weeks and sustained ≥50% reductions through the 12-week treatment period with fremanezumab versus placebo.

Table: Least-squares mean change in monthly migraine days over 12 weeks [1]

Fremanezumab was generally safe and well-tolerated, with similar incidences of adverse events (AEs) compared with placebo [2]. The most common AEs (incidence ≥5%) were injection-site erythema, injection-site induration, and nasopharyngitis. Individual cardiovascular or hepatobiliary AEs were reported by <1% of patients in each treatment group. AEs leading to discontinuation and serious AEs were infrequent (≤1%) across treatment groups. No serious AEs were considered to be treatment-related by investigators, and no safety signals were identified.

A third analysis showed that fremanezumab treatment significantly reduced any as well as migraine-specific acute headache medication use compared with placebo in the FOCUS study [3].

1. 
   
   1. Spierings EL, et al. EAN 2019, EPO3113.
   2. Ferrari M, et al. EAN 2019, EPO2127.
   3. Diener HC, et al. EAN 2019, EPO1136.

 



Posted on 27 August, 201917 March, 2021