• Paul K Winner, Spierings Egilius L H ELH MedVadis Research Corporation, Watertown, MA, USA., Paul P Yeung, Ernesto Aycardi, Tricia Blankenbiller, Melissa Grozinski-Wolff, Ronghua Yang, and Yuju Ma.
• Premiere Research Institute, West Palm Beach, FL, USA.
• Headache. 2019 Nov 1; 59 (10): 1743-1752.

ObjectiveTo assess the onset of efficacy for fremanezumab in chronic migraine by evaluating pain-related clinical measures at different time points.BackgroundFaster onset of efficacy of preventive treatments could benefit patients with migraine. Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, a neuropeptide involved in the pathophysiology of migraine. In 12-week clinical trials, subcutaneous fremanezumab significantly reduced the frequency of migraine headaches, headache hours, and headaches in general, without serious treatment-related adverse events. New drug classes of migraine preventive treatment demonstrate markedly different clinical profiles from standard-of-care treatments.MethodsIn this double-blind phase III study, eligible patients were randomized 1:1:1 to receive subcutaneous injections of fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (675 mg at baseline, 225 mg at weeks 4 and 8), or placebo at each time point. This study included secondary, exploratory, and post hoc analyses of the primary trial, evaluating the change in headache days of at least moderate severity or migraine days during the first 4 weeks of the trial.ResultsA total of 1130 patients were randomized (fremanezumab quarterly, n = 376; fremanezumab monthly, n = 379; or placebo, n = 375). During the 4-week period after the first dose, the mean number of monthly headache days of at least moderate severity was reduced for the all-fremanezumab group (mean reduction [95% confidence interval]: -4.6 days [-5.1, -4.1]) compared with the placebo group (-2.3 days [-2.9, -1.6]; P < .0001). Treatment effects were observed at Week 1 for the all-fremanezumab group (-1.1 days [-1.3, -1.0]) vs placebo (-0.5 days [-0.7, -0.3]; P < .0001), with separation from placebo by Day 2 (P = .003). Similar effects were observed for the monthly average number of migraine days and mean number of monthly headache hours.ConclusionsThe early onset of efficacy of fremanezumab may have the potential to improve patient compliance and clinical outcomes.© 2019 American Headache Society.

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