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Abstract Details

High Frequency Episodic Migraine Shift to Low Frequency Episodic Migraine in Patients Treated with Galcanezumab
Headache
P6 - Poster Session 6 (12:00 PM-1:00 PM)
7-013

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.

 

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.

 

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.

Authors/Disclosures
Eric J. Eross, DO
PRESENTER
No disclosure on file
Virginia L. Stauffer Virginia L. Stauffer has received personal compensation for serving as an employee of Eli Lilly and Company. Virginia L. Stauffer has received stock or an ownership interest from Eli Lilly and company.
Jakub Jedynak Jakub Jedynak has received personal compensation for serving as an employee of Lilly. Jakub Jedynak has received stock or an ownership interest from Lilly.
Astrid Gendolla No disclosure on file
Leah Jin No disclosure on file