Abstract Details

Title Patient Gains in Daily Functioning and Reductions in Disability with Galcanezumab among Patients with Episodic and Chronic Migraine

Topic Headache

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

Poster/Presentation
Number 13-003

Objective To evaluate categorical shifts in patients’ migraine-related disability and functioning after treatment with galcanezumab.

Background The Migraine Disability Assessment (MIDAS) and the Migraine-Specific Quality of Life Questionnaire v.2.1 (MSQ) are patient-reported outcome instruments that assess patients’ migraine-related disability and functional impairment.

Design/Methods The MIDAS and MSQ were performed during three double-blind clinical studies, including two 6-month studies that enrolled patients with episodic migraine (EVOLVE-1 and EVOLVE-2, N=1,773) and one 3-month study of patients with chronic migraine (REGAIN, N=1,113). Based on MIDAS scores, patients were grouped into 5 disability grades, from “little/no disability” up to “very severe disability.” Categorical shifts in MIDAS disability grade from baseline to endpoint were compared between galcanezumab and placebo groups. Individual improvements in the 7 items of the MSQ Role Function-Restrictive domain (MSQ-RR) were also evaluated.

Results Among patients who had “moderate to very severe disability” at baseline in EVOLVE-1&2 (pooled), 44.0% of galcanezumab patients shifted to “little/no disability” at the end of 6 months, compared to 26.5% of placebo patients. Among patients with “very severe disability” at baseline in REGAIN, 49.5% of galcanezumab patients had shifted to lower grade levels at the end of 3 months, compared to 39.9% of placebo patients. Patients using galcanezumab improved their MIDAS disability grade by one or more grades at study completion at significantly (p<0.01) higher rates than were seen with placebo (73.0% vs 57.5% for episodic and 48.6% vs 40.3% for chronic). Significantly (p<0.001) greater percentages of patients showed improvements in each MSQ-RR item for EVOLVE-1&2 when treated with galcanezumab (range: 73.1% to 80.3%) compared to placebo (range: 60.4% to 66.1%); REGAIN results were also significant for most items.

Conclusions Patients treated with galcanezumab for the prevention of episodic or chronic migraine showed lower levels of migraine-related disability and greater improvements in daily functioning compared to placebo.

Authors/Disclosures
Dustin Ruff PRESENTER	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.
	No disclosure on file
Amaal J. Starling, MD, FAAN (Mayo Clinic)	Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Salvia. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Woodberry Associates .
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.
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
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.

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