POS1028 PATIENT CHARACTERISTICS & CLINICAL FEATURES ASSOCIATE WITH HEALTH-RELATED QUALITY OF LIFE IN BIO-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS THROUGH WEEK 24 OF THE DISCOVER-2 STUDY

Abstract

Background:Psoriatic arthritis (PsA) is a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis, & skin/nail psoriasis. Patients (pts) with PsA often experience reduced health-related quality of life (HRQoL) due to these features.Objectives:Using EuroQoL-5 dimension-5 level (EQ-5D-5L) questionnaire index & visual analog scale (EQ-VAS) scores, we assessed HRQoL in pts with PsA & its association with pt characteristics & clinical features of PsA, including fatigue.Methods:The Phase 3 DISCOVER-2 trial evaluated guselkumab (GUS), a human monoclonal antibody targeting the IL-23p19-subunit, in bio-naïve adults with active PsA (swollen joint count [SJC] ≥5, tender joint count [TJC] ≥5, C-reactive protein [CRP] ≥0.6 mg/dL) despite standard therapies.1 Pts were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at Week 0 (W0), W4, then Q8W; or placebo (PBO). EQ-5D-5L index assesses mobility, self-care, usual activities, pain/discomfort, & anxiety/depression. EQ-VAS assesses pt health state. Spearman correlation testing was used to evaluate relationships between baseline (BL) pt characteristics & PsA clinical features & BL EQ-5D-5L index & EQ-VAS scores (Figure 1). Employing absolute observed scores at both W0 & W24, univariate linear regression was used to assess the association between EQ-5D-5L index & EQ-VAS scores & pt characteristics/PsA clinical features. Variables with p<0.20 in the univariate analysis were included in a multivariate analysis employing mixed-effect model for repeated measures (MMRM), controlling for all other variables; resulting p values <0.05 were considered statistically significant. Least-squares (LS) mean changes in EQ-5D-5L index & EQ-VAS were assessed at W24 using MMRM.Results:Among 738 pts, BL EQ-5D-5L index & EQ-VAS scores were moderately to strongly correlated (ie, ≥0.4) with BL pt-reported pain (0-10 VAS), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] scale), & 36-item Short Form Health Survey (SF-36) physical & mental component summary (PCS & MCS) scores & weakly correlated with other variables (Figure 1). Based on univariate analyses (p<0.20) & evaluation of collinearity between variables, attributes at W0 & W24 included in the multivariate models were age, sex, CRP, FACIT-F, pain, psoriasis area & severity index (PASI) score, TJC, SJC, enthesitis, & dactylitis. In the final model, CRP, FACIT-F, pain, PASI score, & the presence of dactylitis were significantly associated with EQ-5D-5L index & EQ-VAS scores. A higher TJC was significantly associated with a worse EQ-5D-5L index score. A higher SJC was significantly associated with a worse EQ-VAS score (Table 1). For reference, in the GUS Q4W (N=244), GUS Q8W (N=246), & PBO (N=244) groups, the LS mean changes from baseline at W24 were 0.12, 0.12, & 0.05, respectively, for EQ-5D-5L index & 18.1, 18.4, & 6.8, respectively, for EQ-VAS.Conclusion:Joint & skin symptoms, dactylitis, fatigue, pain, & elevated levels of CRP were significantly associated with reduced HRQoL (measured by EQ-5D-5L index & EQ-VAS) in bio-naïve pts with active PsA. Treatment of multiple PsA domains may help optimize HRQoL. Improvement across clinical domains1 & in HRQoL has been observed in GUS-treated pts with PsA.