Background: The efficacy and safety of upadacitinib (UPA) in patients (pts) with active psoriatic arthritis (PsA) was demonstrated in the phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials.1,2

Objectives: To explore the relationship between achievement of low disease activity (LDA) or remission (REM) and pt-reported outcomes (PROs) in SELECT-PsA 1 and 2.

Methods: The SELECT-PsA program enrolled pts with prior inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug (DMARD; SELECT-PsA 1) or ≥1 biologic DMARD (SELECT-PsA 2). Pts were randomized to 56 weeks (wks) of blinded treatment with UPA 15 or 30 mg once daily (QD), placebo switched to UPA 15 or 30 mg QD at Wk 24, or adalimumab (SELECT-PsA 1 only) 40 mg every other wk. LDA and REM were evaluated using the minimal disease activity (MDA; fulfillment of 5 out of 7) criteria and the Disease Activity index for Psoriatic Arthritis (DAPSA; cutoff ≤4), respectively. PROs assessed included Health Assessment Questionnaire-Disability Index (HAQ-DI), 36-Item Short-Form Survey physical component summary (SF-36 PCS), 5-Level EuroQol 5-Dimension (EQ-5D-5L) Index, and EQ-5D-5L Visual Analog Scale (VAS). Integrated data through Wk 56 from SELECT-PsA 1 and 2 from the full analysis set with both continuous UPA 15 mg and 30 mg groups were analyzed by responder status at Wks 24 and 56. Changes from baseline (BL) in PROs were analyzed using mixed effects repeated measures models (fixed effects for study, current use of non-biologic DMARDs, treatment group, visit, responder status, and continuous BL PROs). As-observed data were used in the models.

Results: A total of 1281 pts were included in the analysis (UPA 15 mg, n=640; UPA 30 mg, n=641). MDA was achieved by 33% (UPA 15 mg) and 40% (UPA 30 mg) of patients at

Wk 24, and 40% (UPA 15 mg) and 43% (UPA 30 mg) at Wk 56; and DAPSA-REM by 10% (UPA 15 mg) and 17% (UPA 30 mg) at Wk 24, and 16% (UPA 15 mg) and 18% (UPA 30 mg) at Wk 56. Pts who achieved MDA or DAPSA-REM (responders) at Wk 56 achieved larger reductions in HAQ-DI and larger increases in SF-36 PCS, EQ-5D-5L Index and EQ-5D-5L VAS compared with non-responders (Table 1) (all p<0.0001; statistical significance was exploratory in nature). MDA or DAPSA-REM response at Wk 24 was also associated with greater PRO improvements at Wk 56 (Figure 1). Consistent with the results presented for MDA and DAPSA-REM, patients who achieved Very Low Disease Activity or DAPSA-LDA also experienced greater improvements in PROs than those who did not.