Abstract Details

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

To evaluate early effects of fremanezumab treatment on headache severity and duration in patients with chronic or episodic migraine (CM/EM) and inadequate response to 2-4 prior migraine preventive medication classes.

The FOCUS study was a randomized, double-blind, placebo-controlled phase 3b study in adults with prior inadequate response to 2-4 migraine preventive medication classes. Eligible patients were randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or matched placebo for 12 weeks. Changes from baseline at 4 weeks were evaluated for average headache severity (patient-rated on a scale of 1=mild to 3=severe), monthly average headache hours of any severity and at least moderate severity, and average headache hours per headache day of any severity.

Data were evaluated for 837 enrolled patients. Reductions in average headache severity at 4 weeks were higher with quarterly and monthly fremanezumab dosing (least-squares mean [LSM] change from baseline: quarterly, −0.2; monthly, −0.2) versus placebo (−0.1; both P<0.0001). At 4 weeks, reductions were also seen in monthly average number of headache hours of any severity with fremanezumab (LSM change from baseline: quarterly, −28.1; monthly: −31.4) versus placebo (−3.6; both P<0.0001) and in monthly average number of headache hours of at least moderate severity with fremanezumab (quarterly, −19.6; monthly, −20.1) versus placebo (−2.9; both P<0.0001). Lastly, reductions in average number of headache hours per headache day of any severity at 4 weeks were higher with fremanezumab (LSM change from baseline: quarterly, −0.8; monthly: −0.9) versus placebo (−0.0; both P<0.0001).

After 4 weeks of treatment, quarterly and monthly fremanezumab treatment reduced both headache severity and duration in patients with CM or EM and inadequate response to 2-4 prior migraine preventive medication classes.