Abstract Details

Fremanezumab is a fully humanized monoclonal antibody (IgGΔa) that selectively targets calcitonin gene-related peptide (CGRP) and has proven efficacy for the preventive treatment of migraine in adults.

To assess efficacy in patients who switched from quarterly fremanezumab during the double-blind period (DBP) to monthly fremanezumab (switch subgroup) in the open-label extension (OLE) and in patients who received monthly fremanezumab (maintenance subgroup) throughout the DBP and OLE in the FOCUS study.

FOCUS included a 12-week DBP and 12-week OLE. Patients were initially randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or matched placebo for the DBP. All patients completing the DBP entered the OLE and received monthly fremanezumab (three 225-mg doses). Efficacy measures during OLE were summarized by DB randomization group.

Of 838 patients randomized, 807 completed the DBP and entered the OLE: 271 were in the switch subgroup and 272 in the maintenance subgroup. For patients in the switch and maintenance subgroups, respectively, comparable mean changes from baseline during the OLE were observed in monthly average migraine days (−5.1 and −5.5), headache days of at least moderate severity (−4.8 and −5.2), and days of any acute headache medication use (−4.9 and −4.8). The proportion of patients who achieved ≥50% reduction from baseline in monthly average migraine days during the OLE was also comparable in the switch (45%) and maintenance (46%) subgroups. During the OLE, mean changes from baseline in disability outcomes were also similar for patients in the switch and maintenance subgroups, respectively, including the 6-item Headache Impact Test (−8.4 and −8.3) and Migraine Disability Assessment (−29.9 and −33.9).

Efficacy was comparable in patients switching from quarterly to monthly fremanezumab during the OLE and those maintained on monthly dosing throughout the DBP and OLE.