Phase 3 Studies (EVOLVE-1 & EVOLVE-2) of Galcanezumab in Episodic Migraine: Subgroup Analyses of Efficacy by Low-Versus High-Frequency of Migraine Headaches (S17.003)

Objective: To investigate the efficacy of galcanezumab in episodic migraine (EM) by subgroups of low-versus high-frequency of migraine headaches. Background: Migraine is a neurological disorder with high disease burden and unmet clinical need. Design/Methods: Data were pooled from two phase 3 randomized trials. Headaches were tracked via an electronic patient-reported outcome system, and randomization was stratified by low-frequency (LFEM; 4–7 monthly migraine headache days [MHD]) or high-frequency (HFEM; 8–14 monthly MHD). Subgroup analysis of efficacy data, including functional impact and disability measures, were conducted for LFEM and HFEM subgroups with a linear or generalized linear mixed model repeated measures approach. Results: For intent-to-treat patients (N=1773), mean age was 41.3 years, majority were white (75%), female (85%), and HFEM was present in 66% of patients. There were no statistically significant (p Conclusions: Overall, treatment effects of both doses of galcanezumab were similar with regard to reduction in monthly MHD, improved functioning, and reduced disability for both LFEM and HFEM subgroups. The percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in MHDs were similar between LFEM and HFEM subgroups. Disclosure: Dr. Silberstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals, Allergan, Amgen, Avanir, eNeura, ElectroCore Medical, Labrys Biologics, Medscape, Medtronic, Neuralieve, NINDS, Pfizer, and Teva. Dr. Silberstein has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Silberstein has received royalty, license fees, or contractual rights payments from Biohaven. Dr. Silberstein holds stock and/or stock options in Biohaven which sponsored research in which Dr. Silberstein was involved as an investigator. Dr. Silberstein holds stock and/or stock options in Biohaven. Dr. Silberstein has received research support from Allergan, Amgen, Cumberland Pharmaceuticals, ElectroCore Medical, Labrys Biologics, Eli Lilly, Merz, and Troy Healthcare.. Dr. Stauffer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Day has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Lipsius has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Syneos Health. Dr. Wilson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, electroCore Medical, Lilly USA, and Teva Pharmaceuticals.