Upadacitinib as monotherapy and in combination with non-biologic dmards for the treatment of psoriatic arthritis: subgroup analysis from two phase 3 trials

Aim: Approximately 40% of PsA patients (pts) on advanced therapy are on monotherapy.This analysis assessed the efficacy and safety in the subgroups of pts who were treated with Upadacitinib (UPA) as monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (non-bDMARDs) in SELECT-PsA1 and SELECT-PsA 2. Methods: The SELECT-PsA program enrolled pts with prior inadequate response (IR) or intolerance to ≥1 non-bDMARD (N=1705) and prior IR or intolerance to ≥1 bDMARD (N=642). Data from both trials was integrated for pts receiving placebo (PBO), UPA 15 mg once daily (QD) and UPA 30 mg QD; adalimumab data was excluded from this analysis as it was only evaluated in SELECT-PsA 1. This analysis includes ACR20/50/70 responses and change from baseline in pain and HAQ-DI (Week 12); Static Investigator Global Assessment of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline and PASI75/90/100 responses (Week 16); proportion of pts achieving resolution of enthesitis, dactylitis, and minimal disease activity (Week 24). Treatment-emergent adverse events (TEAEs) were analyzed and summarized through Week 24. Results: Both UPA monotherapy and combination therapy led to improvements in efficacy outcomes vs PBO. Across endpoints, for each UPA dose, generally consistent point estimates of the PBO subtracted treatment effect and associated overlapping CIs were observed between pts who were on UPA monotherapy and those who were on combination therapy. Generally, the frequency of AEs, including serious AEs, were comparable with UPA when administered as monotherapy and combination therapy. The frequency of AEs of serious infections and hepatic disorder were lower with monotherapy while the frequency of AEs leading to discontinuation of study drug were lower with combination therapy. Conclusion: In the SELECT PsA Phase 3 trials, the efficacy and safety of UPA was generally consistent when administered as monotherapy or when given in combination with non-bDMARDs.