POS1028 PATIENT CHARACTERISTICS &amp; 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
Authors: J. Curtis, I. Mcinnes, D. D. Gladman, F. Yang, S. Peterson, P. Agarwal, A. Kollmeier, E. C. Hsia, C. Han, M. Shawi, W. Tillett, P. J. Mease, P. Rahman
Journal: Annals of the Rheumatic Diseases (2021)

Background: Psoriatic arthritis (PsA) is a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis, &amp; 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 &amp; visual analog scale (EQ-VAS) scores, we assessed HRQoL in pts with PsA &amp; its association with pt characteristics &amp; 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, &amp; anxiety/depression. EQ-VAS assesses pt health state. Spearman correlation testing was used to evaluate relationships between baseline (BL) pt characteristics &amp; PsA clinical features &amp; BL EQ-5D-5L index &amp; EQ-VAS scores (Figure 1). Employing absolute observed scores at both W0 &amp; W24, univariate linear regression was used to assess the association between EQ-5D-5L index &amp; EQ-VAS scores &amp; pt characteristics/PsA clinical features. Variables with p&lt;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 &lt;0.05 were considered statistically significant. Least-squares (LS) mean changes in EQ-5D-5L index &amp; EQ-VAS were assessed at W24 using MMRM. Results: Among 738 pts, BL EQ-5D-5L index &amp; 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), &amp; 36-item Short Form Health Survey (SF-36) physical &amp; mental component summary (PCS &amp; MCS) scores &amp; weakly correlated with other variables (Figure 1). Based on univariate analyses (p&lt;0.20) &amp; evaluation of collinearity between variables, attributes at W0 &amp; W24 included in the multivariate models were age, sex, CRP, FACIT-F, pain, psoriasis area &amp; severity index (PASI) score, TJC, SJC, enthesitis, &amp; dactylitis. In the final model, CRP, FACIT-F, pain, PASI score, &amp; the presence of dactylitis were significantly associated with EQ-5D-5L index &amp; 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), &amp; PBO (N=244) groups, the LS mean changes from baseline at W24 were 0.12, 0.12, &amp; 0.05, respectively, for EQ-5D-5L index &amp; 18.1, 18.4, &amp; 6.8, respectively, for EQ-VAS. Conclusion: Joint &amp; skin symptoms, dactylitis, fatigue, pain, &amp; elevated levels of CRP were significantly associated with reduced HRQoL (measured by EQ-5D-5L index &amp; EQ-VAS) in bio-naïve pts with active PsA. Treatment of multiple PsA domains may help optimize HRQoL. Improvement across clinical domains 1 &amp; in HRQoL has been observed in GUS-treated pts with PsA. References: [1]Mease P, et al. Lancet 2020;395:1126-36. Table 1. Multivariate analysis of pt characteristics/clinical features &amp; EQ-5D-5L index &amp; EQ-VAS scores at W0 &amp; W24 Parameter EQ-5D-5L Index EQ-VAS Estimate p value Estimate p value Age (y) -0.0001 0.69 0.06 0.12 Female -0.003 0.53 1.11 0.20 CRP (mg/dL) -0.005 &lt;0.001 -0.51 0.007 FACIT-F (0-52) 0.007 &lt;0.001 0.57 &lt;0.001 Pain (0-10) -0.02 &lt;0.001 -3.47 &lt;0.001 PASI (0-72) -0.001 0.03 -0.17 &lt;0.001 SJC (0-66) -0.001 0.21 -0.17 0.02 TJC (0-68) -0.001 0.04 -0.04 0.41 Dactylitis (Y/N) 0.01 0.02 1.74 0.49 Enthesitis (Y/N) -0.004 0.33 -0.98 0.22 Disclosure of Interests: Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Regeneron, Roche, and UCB, Iain McInnes Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, and UCB, Dafna D Gladman Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Grant/research support from: Abbvie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Feifei Yang Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Global Services, LLC, Steve Peterson Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Global Services, LLC, Prasheen Agarwal Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Alexa Kollmeier Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Elizabeth C Hsia Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Chenglong Han Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, May Shawi Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Global Services, LLC, William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, MSD, Pfizer, and UCB, Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, SUN, and UCB, Proton Rahman Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Janssen and Novartis.