CORRELATION ANALYSIS OF THE CHANGE IN THREE SF-36 DOMAINS WITH CHANGE IN PATIENT-IDENTIFIED MOST BOTHERSOME SYMPTOM AND MONTHLY MIGRAINE DAYS IN PATIENTS WITH CHRONIC MIGRAINE: RESULTS OF THE PROMISE-2 STUDY
Author(s)
Young WB1, Ailani J2, Buse DC3, Horblyuk R4, Hirman J5, Cady R6
1Thomas Jefferson University Hospital, Philadelphia, PA, USA, 2Department of Neurology, Georgetown University Hospital, Washington, DC, USA, 3Albert Einstein College of Medicine, Bronx, NY, USA, 4AESARA, Inc., Bristol, PA, USA, 5Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA, 6Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA
Presentation Documents
OBJECTIVES: A previous PROMISE-2 analysis demonstrated that Patient Global Impression of Change responses are more closely correlated with changes in patient-identified most bothersome symptom (MBS) (r=0.83) than changes in monthly migraine days (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. This analysis evaluated the relationship between changes in 36-item Short-Form Heath Survey (SF-36) domains most impacted in patients with migraine and changes in patient-identified MBS and MMDs among patients with chronic migraine (CM). METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled trial evaluating eptinezumab (100mg, 300mg) for the preventive treatment of CM (N=1072). Unlike MBS in acute trials, patients verbally identified any MBS associated with migraine attacks at screening and rated changes using a 7-point Likert scale ranging from “very much worse” to “very much improved.” The SF-36 measures overall HRQOL; this analysis focuses on HRQOL changes from baseline in bodily pain (BP), role-physical (RP), and social functioning (SF) domains. Associations between variables were evaluated with Spearman correlations in the total pooled population. RESULTS: At Weeks 4 and 12, improvements for both eptinezumab doses versus placebo were noted in change from baseline in MMDs, MBS, and SF-36 scores. All SF-36 scores were numerically more closely 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 (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). CONCLUSIONS: After initial administration of eptinezumab, changes in MBS and MMDs were similarly correlated with improvements in SF-36 domains most impacted in patients with migraine at the end of 12 weeks, supporting MBS as an important influence on HRQOL.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PND102
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders