Fremanezumab was found to be effective and well-tolerated in patients with migraine who have not responded to prior preventive treatment, according to study results published in the Lancet.
The study included participants aged 18 to 70 years with episodic or chronic migraine who had a documented lack of response to 2 to 4 classes of migraine preventive medications in the prior 10 years (n=838). Failure to respond to treatment was defined as a lack of clinically meaningful improvement after ≥3 months of therapy at a stable dose, discontinuation due to adverse events, or treatment that is contraindicated or considered unsuitable. Participants were enrolled from 104 sites including hospitals, medical centers, research institutes, and group practice clinics in Belgium, the Czech Republic, Denmark, Finland, France, Germany, Italy, The Netherlands, Poland, Spain, Sweden, Switzerland, the United Kingdom, and the United States.
Participants were randomly assigned at a 1:1:1 ratio to receive subcutaneous quarterly fremanezumab (month 1, 675 mg; months 2 and 3, placebo), monthly fremanezumab (month 1: 225 mg for episodic migraine and 675 mg for chronic migraine; months 2 and 3, 225 mg for both types of migraine), or matched monthly placebo for 12 weeks. The primary outcome was mean change from baseline in the average number of migraine days per month during the treatment period.
In this cohort, 329 patients (39%) had episodic migraine and 509 (61%) had chronic migraine.
Compared with placebo, quarterly fremanezumab resulted in a greater reduction in monthly average migraine days (least-squares mean [LSM] difference vs placebo, −3.1; 95% CI, −3.8 to −2.4; P <.0001) and in monthly average migraine days (LSM difference vs placebo, −3.5; 95%CI, −4.2 to −2.8; P <.0001).
Placebo and fremanezumab had similar adverse events, with serious adverse events occurring in 4 patients taking placebo (1%), 2 patients taking quarterly fremanzumab (<1%), and 4 patients (1%) taking monthly fremanezumab.
“The therapeutic gain vs placebo was higher than in previous studies with fremanezumab or other migraine preventive medications, despite, or perhaps as a result of, the severity of the migraine study population,” noted the researchers.
Disclosure: This clinical trial was supported by Teva Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.
Ferrari MD, Diener HC, Ning X, et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394:1030-1040.