To evaluate onset of efficacy of galcanezumab (GMB) in patients with episodic/chronic migraine.

GMB, approved for migraine, a humanized monoclonal antibody that binds to and prevents neurogenic inflammatory action of CGRP, significantly elevated in migraine attacks.

 Migraine headache during the first 7 days including and following initial treatment was analyzed for patients from 3 double-blind, Phase-3 studies. EVOLVE-1 (N=858) and EVOLVE-2 (N=915) were 6-month studies in patients with episodic migraine; REGAIN (N=1,113) was a 3-month study in patients with chronic migraine. Patients were randomized(2:1:1) to monthly injections with placebo (PBO), GMB-120mg with a 240mg loading dose, or GMB-240mg. Onset of efficacy was the earliest time point at which GMB became superior to PBO and maintained for primary outcome (change in migraine headache days [MHD]). Monthly,weekly analyses were based on mean change from baseline in MHD; daily analyses were based on percent of patients with migraine headache on day of injection through 6 days post-injection.

 As GMB was superior to PBO in reducing MHD at the first month and even as early as the first week, daily analyses were conducted. In baseline periods, daily average of 30% of patients in the EVOLVE-1 and EVOLVE-2 trials, and 65% of patients with chronic migraine in REGAIN trial experienced migraine headache. At Day 1 post-injection, significantly fewer GMB-treated patients experienced MHD versus PBO-treated patients (EVOLVE-1: 14% in GMB vs 22% in PBO,p=.002; EVOLVE-2: 18% in GMB vs 24% in PBO,p=.038; REGAIN: 49% in GMB vs 58% in PBO,p=.004). GMB-treated patients maintained significantly lower MHD rates for each remaining day during the first week of treatment compared with PBO-treated patients in all 3 studies (all p-values<0.05).  

GMB showed statistically superior efficacy to PBO starting at Day 1 after injection and the effect was sustained throughout in both episodic and chronic migraine patients.