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Abstract Details

Correlation Analysis of the Change in SF-36 with Change in Patient-Identified Most Bothersome Symptom and Monthly Migraine Days (MMDs) in Patients with Chronic Migraine (CM): Results of the PROMISE-2 Study
Headache
P14 - Poster Session 14 (8:00 AM-9:00 AM)
7-003
To evaluate the relationship between changes in 36-item Short-Form Heath Survey (SF-36) and changes in patient-identified most bothersome symptom (MBS) and MMDs among patients with CM.
A previous analysis of PROMISE-2 data demonstrated that changes in MBS are highly correlated with Patient Global Impression of Change (r=0.83) and change in MMDs (r=0.51). It is not known whether changes in health-related-quality of life (HRQOL) are more closely associated with changes in MBS or MMDs in patients with migraine. 
PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled trial evaluating eptinezumab for the preventive treatment of migraine in patients with CM (N=1072). MMDs were captured in a daily eDiary. Unlike MBS in acute trials, patients verbally identified the MBS associated with their migraines at screening and rated changes using a 7-point rating scale from “very much improved” to “very much worse”. The SF-36 is a validated measure of overall HRQOL widely used in research; this analysis focuses on changes from baseline in the bodily pain (BP), role-physical (RP), and social functioning (SF) domains. Spearman correlations were used to evaluate associations between variables. 
At Weeks 4 and 12, improvements vs placebo were noted in change from baseline in MMDs, MBS, and SF-36 scores for both doses of eptinezumab. All SF-36 scores were numerically more correlated with MBS than with MMDs at Week 4 (BP: MBS, r=0.40; MMDs, r=−0.32; RP: MBS, r=0.39; MMDs, r=−0.29; SF: MBS, r=0.30; MMDs, r=−0.23). At Week 12, the correlations were similar between variables (BP: MBS, r=0.35; MMDs, r=−0.32; RP: MBS, r=0.33; MMDs, r=−0.29; SF: MBS, r=0.26; MMDs, r=−0.27)
After initial intravenous administration of eptinezumab, changes in MBS and MMDs were similarly correlated with improvements in SF-36 domains at the end of 12 weeks, supporting MBS as an important influence on HRQOL.
Authors/Disclosures
William B. Young, MD, FÂ鶹´«Ã½Ó³»­ (Jefferson Headache Center)
PRESENTER 		Dr. Young has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven Pharmaceuticals. Dr. Young has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly and Company. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Young has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven Pharmaceuticals Inc. Dr. Young has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly and Company. Dr. Young has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Young has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Coalition for Headache and Migraine Patients. Dr. Young has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Miles for Migraine. The institution of Dr. Young has received research support from Amgen. The institution of Dr. Young has received research support from Cumberland. The institution of Dr. Young has received research support from Eli Lilly. The institution of Dr. Young has received research support from Novartis. The institution of Dr. Young has received research support from PCORI. The institution of Dr. Young has received research support from Satsuma. The institution of Dr. Young has received research support from Scion. The institution of Dr. Young has received research support from Teva. The institution of Dr. Young has received research support from Zosano.
Jessica Ailani, MD, FÂ鶹´«Ã½Ó³»­ (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Dawn C. Buse, PhD (Dawn C. Buse, PhD) 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
Roger Cady, MD (RK Consulting, LLC) Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.