POS0200 CLINICAL CHARACTERISTICS &amp; OUTCOMES ASSOCIATE WITH WORK PRODUCTIVITY 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), a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis &amp; skin/nail psoriasis, causes impaired physical function, disability &amp; loss of work productivity. Objectives: Evaluate associations between PsA clinical characteristics &amp; outcomes including fatigue &amp; work productivity using Work Productivity &amp; Activity Impairment Questionnaire: PsA (WPAI-PsA). Methods: The Phase 3 DISCOVER-2 trial assessed guselkumab (GUS), an anti-IL-23p19 subunit monoclonal antibody, in bio-naïve adults with active PsA (swollen joint count [SJC] ≥5 &amp; tender joint count [TJC] ≥5, C-reactive protein [CRP] ≥0.6 mg/dL) despite standard therapies. 1 Patients (Pts) were randomized 1:1:1 to GUS 100 mg Q4W; GUS 100 mg at W0, W4, then Q8W; or placebo (PBO). WPAI-PsA assesses PsA-related work time missed (absenteeism), impairment while working (presenteeism), productivity loss (absenteeism+presenteeism), &amp; daily activity during the previous week. Spearman correlation testing evaluated relationships between pt demographics &amp; disease characteristics of PsA &amp; WPAI domain scores based on observed values at baseline. Univariate linear regression assessed associations between WPAI &amp; these variables based on observed data at W0 &amp; at W24. Variables with p&lt;0.10 were included in a multivariate analysis employing a mixed-effects model for repeated measures, controlling for all other variables; resulting p-values &lt;0.05 were considered statistically significant. Results: As reported elsewhere, 2 least-squares mean % changes from baseline at W24 were -3.8/-19.5/-20.0/-20.5 for GUS Q4W, -3.1/-19.4/-19.7/-21.5 for GUS Q8W, &amp; -3.5/-10.2/-10.9/-10.3 for PBO for absenteeism, presenteeism, absenteeism+presenteeism, &amp; daily activity impairment, respectively. Among 738 pts, WPAI domain scores were moderately to strongly correlated (ie, ≥0.4) with pt-reported pain (0-10 visual analog scale), 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 Component Summary (PCS) score, but weakly correlated with other variables (Figure 1). Based on univariate analyses &amp; evaluation of collinearity between variables, attributes included in multivariate models were age, body mass index (BMI), gender, CRP, FACIT-F, pain, Psoriasis Area Severity Index (PASI), TJC, SJC, enthesitis &amp; dactylitis. In final model, CRP, FACIT-F, &amp; pain were statistically significantly associated with all WPAI domains (Table 1). Presence of enthesitis &amp; higher PASI score were significantly associated with higher loss of work productivity &amp; activity outside work. Conclusion: In PsA pts, extra-articular symptoms, fatigue, pain &amp; elevated CRP were significantly associated with WPAI-assessed work &amp; activity impairment. Treating all major clinical manifestations of PsA is needed to help pts improve work &amp; activity impairment. GUS effectively treats all major clinical manifestations 1 &amp; improves work &amp; activity impairment in PsA. 2 References: [1]Mease P. Lancet 2020;395:1126-36. [2]Curtis J. ACR 2020; Poster 0332. Table 1. Multivariate analysis of clinical characteristics/outcomes &amp; WPAI domains at W0 &amp; W24 Parameter Absenteeism a Presenteeism a Productivity Loss a Activity Impairment b Estimate p-value Estimate p-value Estimate p-value Estimate p-value Age -0.05 0.42 -0.27 &lt;0.001 -0.28 &lt;0.001 -0.06 0.17 Female 0.91 0.46 -1.54 0.22 -1.74 0.20 2.38 0.02 CRP 0.73 0.04 0.97 0.01 1.01 0.01 0.89 &lt;0.001 FACIT-F -0.31 &lt;0.001 -0.67 &lt;0.001 -0.73 &lt;0.001 -0.75 &lt;0.001 Pain 1.03 &lt;0.001 4.15 &lt;0.001 4.25 &lt;0.001 4.02 &lt;0.001 PASI 0.06 0.36 0.16 0.02 0.14 0.05 0.15 0.003 SJC 0.08 0.48 -0.05 0.61 -0.05 0.66 0.03 0.75 TJC -0.10 0.13 0.11 0.09 0.09 0.19 0.10 0.04 Dactylitis (Y/N) -1.10 0.39 2.47 0.05 2.58 0.05 0.54 0.57 Enthesitis (Y/N) 1.52 0.20 2.38 0.04 2.99 0.01 2.40 0.01 a Pts working at baseline b All pts in study Disclosure of Interests: Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Eli Lilly, Myriad, Pfizer, Regeneron, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Eli Lilly, 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: Janssen, Employee of: Janssen, Steve Peterson Shareholder of: Janssen, Employee of: Janssen, Prasheen Agarwal Shareholder of: Janssen, Employee of: Janssen, Alexa Kollmeier Shareholder of: Janssen, Employee of: Janssen, Elizabeth C Hsia Shareholder of: Janssen, Employee of: Janssen, Chenglong Han Shareholder of: Janssen, Employee of: Janssen, May Shawi Shareholder of: Janssen, Employee of: Janssen, 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, and 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, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Roche, 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