Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials.

Abstract

Background and purposeThe efficacy of galcanezumab, a monoclonal antibody for migraine prevention, has been demonstrated in two pivotal trials in patients with episodic migraine.MethodsEVOLVE‐1 and EVOLVE‐2 were identical phase 3, randomized, double‐blind, placebo‐controlled studies in patients with episodic migraine. Mean migraine headache days per month at baseline was 9. Patients were randomized 2:1:1 to monthly injections of placebo, galcanezumab 120 mg/240 mg during the 6‐month double‐blind treatment period. Key efficacy outcomes were assessed in subgroups amongst patients for whom, previously, for efficacy and/or safety/tolerability reasons (i) one or more (≥1) preventives failed, (ii) two or more (≥2) preventives failed and (iii) preventives were never used, or used but not failed (no prior failure).ResultsIn an integrated analysis of EVOLVE studies, galcanezumab 120 mg/240 mg versus placebo led to larger overall mean (SE) reductions in monthly migraine headache days across 6 months in patients with prior preventive failures (P < 0.001): ≥1 failure: 120 mg: −4.0 (0.4); 240 mg: −4.2 (0.5); placebo: −1.3 (0.4); ≥2 failures: 120 mg: −3.1 (0.7); 240 mg: −3.8 (0.8); placebo: −0.5 (0.6). Similar results were observed amongst patients with no prior failure, but the placebo response was larger: 120 mg: −4.7 (0.2); 240 mg: −4.5 (0.2); placebo: −3.0 (0.2) (P < 0.001 versus placebo). Significant improvements were observed with galcanezumab versus placebo for ≥50% and ≥75% reduction in monthly migraine headache days.ConclusionIn patients with episodic migraine treated with galcanezumab, those with ≥1 or ≥2 prior preventive failures had significantly larger improvements, versus placebo, in efficacy outcomes. Similar results were observed in patients with no prior failure, with a larger placebo response.