The rapid onset of treatment effects following fremanezumab use has the potential to improve patient compliance and clinical outcomes, according to a study published in Headache.
The investigators of this double-blind phase 3 study sought to assess the onset of efficacy for fremanezumab in the preventive treatment of chronic migraine by evaluating the frequency of migraine headaches, headache hours, and general headache days at different time points.
The study included 1130 adults with a history of migraine headache who were randomly assigned to receive subcutaneous injections of fremanezumab quarterly (n=376), fremanezumab monthly (n=379), or a placebo (n=375) over 12 weeks. The investigators performed secondary, exploratory, and post hoc analyses to evaluate change in headache days (at least moderately severe), migraine days, and headache hours over the treatment period as well as in the 4 weeks following the first dose.
Over 12 weeks, the mean number of monthly headache days was reduced in the fremanezumab quarterly group by 4.3 days (95% CI, -4.9 to -3.7), in the fremanezumab monthly group by 4.6 days (95% CI, -5.2 to -4.0), and in the placebo group by 2.5 days (95% CI, -3.1 to -1.9). Significant treatment effects were observed in the 4 weeks following the initial dose, in which all participants receiving fremanezumab experienced a significant reduction in the mean number of monthly headache days (-4.6 days; 95% CI, -5.1 to -4.1) vs patients receiving placebo (-2.3 days; 95% CI, -2.9 to -1.6; P <.0001). In fact, the treatment effect was considered significant after 1 week of fremanezumab therapy (-1.1 days; 95% CI, -1.3 to -1.0) vs placebo (-0.5 days; 95% CI, -0.7 to -0.3; P <.0001) and separation between treatment and placebo groups were observed by day 2 (P =.003). Other clinical measures (monthly migraine days and monthly headache hours) showed similar treatment effects in the 4 weeks following the first dose.
Limitations to the study included certain analyses that were not defined as a priori and effect sizes at early time points were not necessarily considered to be clinically meaningful.
The investigators of the study concluded that both fremanezumab quarterly and monthly regimens were associated with rapid treatment onset indicated by significant reductions in headache days, migraine days, and headache hours within the first 4 weeks of treatment. Patients with a history of chronic migraine may benefit from fremanezumab as a preventive treatment.
This study was funded by Teva Pharmaceutical Industries Ltd. Multiple authors declare affiliations with the pharmaceutical industry. Please see the reference for a complete list of authors’ disclosures.
Winner PK, Spierings ELH, Yeung PP, et al. Early onset of efficacy with fremanezumab for the preventive treatment of chronic migraine. Headache. 2019;59(10):1743-1752.