Abstract Details

Title Changes in Work Productivity and Interictal Burden: Results from a Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Galcanezumab in Adults with Treatment-Resistant Migraine (CONQUER)

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-001

Objective To evaluate changes from baseline in work productivity/activity impairment and interictal burden attributed to migraine among patients treated with galcanezumab or placebo.

Background The implications of migraine include reduced work productivity and activity impairment, both during and between migraine attacks; which are even greater among patients who did not receive benefit from prior preventive treatments.

Design/Methods In the 3-month double-blind phase of a randomized, placebo-controlled galcanezumab study (#NCT03559257), patients with episodic or chronic migraine, who had multiple failures to previous migraine preventive treatments, received (1:1) subcutaneous injection of galcanezumab 120 mg/month (following initial 240 mg loading dose) or placebo. Absenteeism, presenteeism (impairment while working), work productivity loss, and activity impairment scores from the Work Productivity and Activity Impairment Questionnaire (WPAI) were calculated as impairment percentages; group comparisons were conducted using ANCOVA. The 4-item Migraine Interictal Burden Scale (MIBS) assessed migraine-burden between attacks over the past 4 weeks (total score range 0-12; 0=none and ≥5=severe); changes were evaluated using a mixed-model repeated measures approach. For both scales, higher scores indicated greater impairment, less productivity, and/or greater disruptions.

Results Of the 462 patients randomized to galcanezumab (n=232) or placebo (n=230), 97.6% completed the 3-month, double-blind phase. At baseline, the majority of patients were working for pay (71.9% galcanezumab, 69.9% placebo). The least squares (LS) mean reductions of WPAI scores from baseline were significantly greater (all p≤0.0004) in the galcanezumab group compared with placebo in the percent of activity impairment (-20.7% vs -8.6%), presenteeism (-12.5% vs -2.6%), and overall work impairment (-14.3% vs -3.5%); absenteeism was not significantly different. The LS mean change from the MIBS baseline (5.5, indicative of severe interictal burden) was greater for the galcanezumab group (-1.8) compared with placebo (-0.8; p<0.0001).

Conclusions Greater reductions in work productivity/activity impairment and interictal burden due to migraine were seen in galcanezumab-treated patients relative to placebo.

Authors/Disclosures
Dawn C. Buse, PhD (Dawn C. Buse, PhD) PRESENTER	Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranicsa. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Linda Wietecha, RN, MS (Eli Lilly & Company)	Ms. Wietecha has received personal compensation for serving as an employee of Eli Lilly and Company. Ms. Wietecha has received stock or an ownership interest from 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.