Determine if galcanezumab 120mg once-monthly subcutaneous injection maintains efficacy throughout the dosing interval.

Galcanezumab, a monoclonal antibody that binds to the CGRP ligand, has established efficacy for the preventive treatment of migraine.   

A post-hoc analysis was conducted on three double-blind, placebo-controlled Phase-3 studies among adults with chronic migraine (CM) and episodic migraine (EM) receiving galcanezumab 120mg (240mg loading dose) or placebo for  three months (REGAIN; N=835) or six months (EVOLVE-1&-2; N=1335). Study endpoints were mean change from baseline in migraine headache days (MHDs), comparing the first two and last two weeks of each study month. Least squared mean changes were estimated using a mixed model for repeated measures analysis.

MHD reduction in the first two weeks of the month was maintained during the last two weeks for CM and EM. In patients with CM, mean MHD reduction in the first two weeks was 1.84, 2.31, and 2.54 with galcanezumab (baseline bi-weekly MHDs = 9.0) versus 0.73, 1.34, and 1.64 with placebo (baseline bi-weekly MHDs = 9.1) of Months 1 through 3, respectively (p<0.001). Mean MHD reduction in the last two weeks was 1.98, 2.35, and 2.66 with galcanezumab versus 1.15, 1.65, and 1.79 with placebo (p<0.001).

In patients with EM, mean MHD reduction was 1.80 and 2.28 with galcanezumab versus 0.51 and 1.46 with placebo in the first 2weeks of Months 1 & 6, respectively (p<0.001). Mean MHD reduction in the last two weeks was 1.77 and 2.34 with galcanezumab versus 0.86 and 1.49 with placebo (p<0.001). Baseline bi-weekly MHDs = 4.3 for both groups.  The same pattern was observed across months 2-5 (p<0.001).

Among patients with EM and CM, galcanezumab 120mg once-monthly maintains efficacy throughout the dosing interval.