To assess the proportion of patients with episodic migraine (EM) who shift from high-frequency EM (HFEM) to low-frequency EM (LFEM) or very low-frequency EM (VLFEM) status for up to 6 months of treatment with galcanezumab.

Patients with EM with a high frequency of migraine headache days (MHD), classified as HFEM, have a greater disease burden and a higher risk of converting to chronic migraine vs. those with LFEM.

EVOLVE-1 and EVOLVE-2 were double-blind, placebo-controlled, Phase-3 studies that enrolled 1773 patients with EM. Patients 18-65 years of age were randomized 2:1:1 to subcutaneous monthly injections of placebo, galcanezumab 120-mg (240-mg loading dose) or 240-mg, for up to 6 months. Data were pooled and endpoints were change from baseline in number of monthly MHD and patients who shifted from HFEM (8-14 MHD) to LFEM (≤7 MHD) or VLFEM (≤3 MHD).

At baseline, 66% of 1773 patients with HFEM had mean monthly MHD of 11 days and Migraine Disability Assessment Score of 37 (severe disability). During treatment phase, more galcanezumab-treated patients shifted to LFEM for 3 or more consecutive months, maintained LFEM until study end (68.4%,69.2% for 120 and 240-mg/month; p<0.001) vs placebo-treated patients (50.7%). Furthermore, significantly more galcanezumab-treated patients maintained LFEM for 3 or more consecutive months (75.2%, 77.1% for 120 and 240-mg/month, respectively; p<0.001) vs placebo (58.3%).

Significantly, more galcanezumab-treated patients shifted to VLFEM for 3 or more consecutive months during the treatment phase (47.7%, 47.7% for 120 and 240-mg/month; p<0.001) vs placebo-treated patients (25.5%). Furthermore, more galcanezumab-treated patients shifted to VLFEM for 3 or more consecutive months and maintained VLFEM until study end (39.9%, 38.6% for 120 and 240-mg/month; p<0.001) vs placebo (19.5%).

Both doses of galcanezumab were superior to placebo in the reduction of monthly MHD, with significantly more patients shifting from HFEM to LFEM or VLFEM postdose.