PND102 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

Abstract

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). 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. 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). 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.