Abstract
BackgroundFremanezumab, a fully humanized monoclonal antibody (IgG2Δa) selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. In this study, we evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab.MethodsEpisodic migraine and chronic migraine patients completing the 12-week double-blind period of the FOCUS trial entered the 12-week open-label extension and received 3 monthly doses of fremanezumab (225 mg). Changes from baseline in monthly migraine days, monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia/phonophobia, days with nausea or vomiting, disability scores, and proportion of patients achieving a ≥50% or ≥75% reduction in monthly migraine days were evaluated.ResultsOf the 807 patients who completed the 12-week double-blind treatment period and entered the open-label extension, 772 patients completed the study. In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing regimens, respectively, patients had fewer average monthly migraine days (mean [standard deviation] change from baseline: − 4.7 [5.4]; − 5.1 [4.7]; − 5.5 [5.0]), monthly headache days of at least moderate severity (− 4.5 [5.0]; − 4.8 [4.5]; − 5.2 [4.9]), days per month of acute headache medication use (− 4.3 [5.2]; − 4.9 [4.6]; − 4.8 [4.9]), days with photophobia/phonophobia (− 3.1 [5.3]; − 3.4 [5.3]; − 4.0 [5.2]), and days with nausea or vomiting (− 2.3 [4.6]; − 3.1 [4.5]; − 3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of patients, respectively, achieved a ≥50% reduction and 16%, 15%, and 20%, respectively, achieved a ≥75% reduction in monthly migraine days. Disability scores were substantially improved in all 3 treatment groups. There were low rates of adverse events leading to discontinuation (<1%).ConclusionFremanezumab demonstrated sustained efficacy up to 6 months and was well tolerated in patients with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes.Trial registrationClinicalTrials.gov NCT03308968 (FOCUS).
Highlights
The burden of migraine is substantial and it includes social and economic burdens in addition to functional impairments [1, 2], which are generally higher for patients who have failed ≥1 prior migraine preventive treatment [3,4,5]
During the DB period and the open-label extension (OLE), for the following outcomes, efficacy was measured as the mean change from baseline during the 12 weeks after the first dose of the DB period and the OLE: monthly average number of migraine days, average monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia/phonophobia, and days with nausea/vomiting
Efficacy was measured according to the proportion of patients achieving ≥50% and ≥75% reduction in the monthly average number of migraine days in the 12 weeks after the first dose of the DB period and the OLE and as the mean change in disability from baseline through the 4 weeks after the last dose of study drug in the DB period and the OLE
Summary
The burden of migraine is substantial and it includes social and economic burdens in addition to functional impairments [1, 2], which are generally higher for patients who have failed ≥1 prior migraine preventive treatment [3,4,5]. Efficacy, and tolerability, as well as the high rate of treatment discontinuations, patients with prior inadequate responses to multiple classes of migraine preventive medications are in need of effective and tolerable long-term treatments for migraine prevention [8]. In the HALO long-term safety study, both fremanezumab quarterly and fremanezumab monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headacherelated disability for up to 12 months in patients with migraine [19]. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. We evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab
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