Abstract Details

Title 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

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-001

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) [15.5 at 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< 0.001).

Conclusions Treatment with galcanezumab resulted in significant reductions in MHDs requiring acute medication use, and migraine-specific HCRU.

Authors/Disclosures
Shivang Joshi, MD (Community Neuroscience Services) PRESENTER	Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Joshi has received personal compensation in the range of $0-$499 for serving as a Consultant for Nerivio. Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Joshi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lundbeck. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for scilex. The institution of Dr. Joshi has received research support from Biohaven.
Joshua Tobin, MD, FAAN (Banner University Medical Center Neurosciences Institute)	An immediate family member of Dr. Tobin has received personal compensation for serving as an employee of Amgen. Dr. Tobin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Tobin has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie.
	No disclosure on file
Russell Nichols	Russell Nichols has received personal compensation for serving as an employee of Eli Lilly and Company. Russell Nichols has received stock or an ownership interest from Eli Lilly and Company.
	No disclosure on file
Dustin Ruff	Dustin Ruff has received personal compensation for serving as an employee of Eli Lilly and Company. Dustin Ruff has stock in Eli Lilly and Company.
Holland Detke	Holland Detke has received personal compensation for serving as an employee of Eli Lilly and Company. Holland Detke has received stock or an ownership interest from Eli Lilly and Company.
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.

��ɫ��

��ɫ��