POS0196 UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS REFRACTORY TO BIOLOGIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS: 56-WEEK DATA FROM THE PHASE 3 SELECT-PSA 2 STUDY

Abstract

Background:Upadacitinib (UPA) is an oral Janus kinase inhibitor currently under evaluation for the treatment of psoriatic arthritis (PsA). Previous 24-week results from the SELECT-PsA 2 study in patients with PsA and prior inadequate response to ≥1 biologic disease-modifying antirheumatic drug (bDMARD) demonstrated UPA efficacy with a safety profile consistent with that observed in rheumatoid arthritis.1Objectives:To evaluate the 56-week efficacy and safety of UPA in the SELECT-PsA 2 study.Methods:Patients were randomized to 56 weeks of blinded treatment with UPA 15 or 30 mg once daily (QD), or placebo (PBO) switched to UPA 15 or 30 mg QD at Week 24. Efficacy endpoints included proportions of patients achieving 20/50/70% improvement in American College of Rheumatology (ACR) criteria (ACR20/50/70), 75/90/100% improvement in the Psoriasis Area and Severity Index (PASI75/90/100), resolution of dactylitis and enthesitis, and minimal disease activity (MDA). Non-responder imputation was used for missing data. Treatment-emergent adverse events (TEAEs) were summarized for events occurring while on UPA and ≤30 days after last dose (for those who discontinued).Results:Of 641 patients who received ≥1 dose of study drug, 74.7% completed 56 weeks of treatment. Clinical improvements based on the proportion of patients achieving ACR20/50/70 and MDA (Figure 1), PASI75/90/100, and resolution of dactylitis and enthesitis were generally maintained through 56 weeks of UPA treatment. Week 56 results for patients who switched from PBO to UPA at Week 24 had a similar trajectory to those for patients originally randomized to UPA. Overall, improvements observed with UPA 15 mg were similar to or approached those with UPA 30 mg over 56 weeks. Dose-dependent increases were observed for exposure-adjusted event rates (EAERs) of serious infections, herpes zoster (HZ), hepatic disorders, hematologic lab-related adverse events, and creatine phosphokinase (CPK) elevations, but not for exposure-adjusted incidence rates (EAIRs) of major adverse cardiovascular events (MACE), venous thromboembolic events (VTEs), or malignancies (Table 1). Generally, rates of TEAEs were lower with UPA 15 mg versus 30 mg.Conclusion:In patients with PsA and prior inadequate response to ≥1 bDMARD, UPA efficacy was maintained over 56 weeks with no new safety signals.