Galcanezumab Significantly Reduced Health Care Resource Utilization and Acute Medication Use in Patients with Chronic Migraine: Findings from a Phase 3, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension (P1.10-001)

Objective: To analyze changes in healthcare resource utilization (HCRU) and acute medication use in patients with chronic migraine following treatment with galcanezumab for 1 year. Background: Migraine is a neurologic disease that results in greater HCRU and increased acute medication use. Migraine is associated with disability when inadequately treated. Galcanezumab, a humanized monoclonal antibody, binds calcitonin gene-related peptide and is approved for migraine prevention. Design/Methods: REGAIN (NCT02614261) was a Phase 3, multicenter, randomized, double-blind (DB), placebo (PB)-controlled study of 2 doses of galcanezumab (120 or 240 mg/month given subcutaneously) for prevention of migraine in patients with chronic migraine. The study consisted of a 3-month DB treatment and an 9-month open-label extension (OLE) phase with flexible dosing. At baseline (BL), patients reported migraine-specific HCRU for the previous 6 months and monthly during the treatment period. Acute medication use for headache was captured daily and estimated on an overall monthly basis. Results: Results are presented by groups, per dose assignment during the DB period: PB, 120-mg galcanezumab (120-mg), and 240-mg galcanezumab (240-mg); 533 patients, 269 patients, and 271 patients were analyzed, respectively. Changes in mean migraine-specific HCRU across BL»DB»OLE phases (per 100 patient-years) included: healthcare professional visits: (PB) 110.7»44.5»29.3, (120-mg) 102.6»29.0»34.0, (240-mg) 143.2»36.0»66.1; emergency room visits: (PB) 21.0»13.9»4.5, (120-mg) 19.3»15.3»4.9, (240-mg) 25.1»15.0»10.6; admissions to hospital: (PB) 1.5»0»1.2, (120-mg) 1.5»0»0, (240-mg) 0.7»0»0; and overnight hospital stays: (PB) 4.9»0»3.0, (120-mg) 3.0»0»0, (240-mg) 3.0»0»0. Mean reductions across time in number of migraine headache days (MHDs)/month with acute medication use for BL»DB, BL»Month 6 OLE, BL»Month 12 OLE included: (PB) [15.5at BL], −2.59, −6.34, −7.04, (120-mg) [15.1 at BL], −4.88, −6.38, −7.62, (240-mg) [14.5 at BL], −4.21, −5.63, −6.77; within-group comparisons were significantly larger for each (p Conclusions: Treatment with galcanezumab resulted in significant reductions in MHDs requiring acute medication use, and migraine-specific HCRU. Disclosure: Dr. Joshi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen, Lilly, Teva, Supernus, Depomed, Promeus. Dr. Tobin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Ford has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eli Lilly and Company. Dr. Ford holds stock and/or stock options in Eli Lilly and Company. Dr. Nichols has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Nichols holds stock and/or stock options in Eli Lilly and Company which sponsored research in which Dr. Nichols was involved as an investigator. Dr. Nichols holds stock and/or stock options in Eli Lilly and Company. Dr. Foster has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Foster holds stock and/or stock options in Eli Lilly and company. Dr. Ruff has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company. Dr. Ruff holds stock and/or stock options in Eli Lilly and Company. Dr. Detke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eli Lilly and Company. Dr. Detke holds stock and/or stock options in Eli Lilly and Company which sponsored research in which Dr. Detke was involved as an investigator. Dr. Aurora has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly and Company.