POS0200 CLINICAL CHARACTERISTICS & OUTCOMES ASSOCIATE WITH WORK PRODUCTIVITY IN BIO-NAÏVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS THROUGH WEEK 24 OF THE DISCOVER-2 STUDY

Background:Psoriatic arthritis (PsA), a chronic inflammatory disease characterized by peripheral arthritis, axial inflammation, dactylitis, enthesitis & skin/nail psoriasis, causes impaired physical function, disability & loss of work productivity.Objectives:Evaluate associations between PsA clinical characteristics & outcomes including fatigue & work productivity using Work Productivity & 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 & 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), & daily activity during the previous week. Spearman correlation testing evaluated relationships between pt demographics & disease characteristics of PsA & WPAI domain scores based on observed values at baseline. Univariate linear regression assessed associations between WPAI & these variables based on observed data at W0 & at W24. Variables with pResults: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, & -3.5/-10.2/-10.9/-10.3 for PBO for absenteeism, presenteeism, absenteeism+presenteeism, & 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) & 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 & 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 & dactylitis. In final model, CRP, FACIT-F, & pain were statistically significantly associated with all WPAI domains (Table 1). Presence of enthesitis & higher PASI score were significantly associated with higher loss of work productivity & activity outside work.Conclusion:In PsA pts, extra-articular symptoms, fatigue, pain & elevated CRP were significantly associated with WPAI-assessed work & activity impairment. Treating all major clinical manifestations of PsA is needed to help pts improve work & activity impairment. GUS effectively treats all major clinical manifestations1 & improves work & activity impairment in PsA.2References:[1]Mease P. Lancet 2020;395:1126-36.[2]Curtis J. ACR 2020; Poster 0332.Table 1.Multivariate analysis of clinical characteristics/outcomes & WPAI domains at W0 & W24ParameterAbsenteeismaPresenteeismaProductivity LossaActivity ImpairmentbEstimatep-valueEstimatep-valueEstimatep-valueEstimatep-valueAge-0.050.42-0.27-0.28-0.060.17Female0.910.46-1.540.22-1.740.202.380.02CRP0.730.040.970.011.010.010.89FACIT-F-0.31-0.67-0.73-0.75Pain1.034.154.254.02PASI0.060.360.160.020.140.050.150.003SJC0.080.48-0.050.61-0.050.660.030.75TJC-0.100.130.110.090.090.190.100.04Dactylitis (Y/N)-1.100.392.470.052.580.050.540.57Enthesitis (Y/N)1.520.202.380.042.990.012.400.01aPts working at baselinebAll pts in studyDisclosure 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