Abstract Details

Early response was evaluated in a subgroup of patients with episodic migraine (EM) or chronic migraine (CM) and medication overuse (use of any acute medication ≥15 days/month or triptan/ergot/combination medication ≥10 days/month) at baseline.

Patients were randomized (1:1:1) to quarterly fremanezumab (Month 1: 675mg; Months 2 and 3: placebo), monthly fremanezumab (Month 1: EM, 225mg; CM, 675mg; Months 2 and 3: 225mg), or matched monthly placebo for 12 weeks. At Weeks 1-3, changes from baseline in weekly migraine days and headache days were evaluated using mixed-effects models for repeated measures and responder rates (≥50% reduction in weekly migraine days) were evaluated using logistic regression.

Of 838 randomized patients, 435 had medication overuse. Reductions from baseline in weekly migraine days were significantly greater with fremanezumab vs placebo by Week 1 (quarterly, −0.9[0.20]; monthly, −1.2[0.18] vs −0.1[0.21]; P≤0.0018), as were reductions in weekly headache days of at least moderate severity (quarterly, −1.0[0.20]; monthly, −1.4[0.18] vs −0.1[0.20]; P≤0.0003). Significantly higher proportions of patients achieved ≥50% reductions in migraine days with fremanezumab vs placebo at Week 1 (quarterly, 39%; monthly, 38% vs 14%; P<0.0001). Significant differences were maintained through Weeks 2 and 3 (all P<0.0001).

Both quarterly and monthly fremanezumab demonstrated early onset of action, with greater response rates within 1 week and significantly greater reductions in weekly migraine days and headache days as early as Week 1 vs placebo, in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive medications.