Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study

Objective To assess the long-term safety and efficacy of upadacitinib in patients with psoriatic arthritis (PsA) and an inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs) who completed up to 152 weeks of treatment in the SELECT-PsA 2 study (ClinicalTrials.gov: NCT03104374). Methods Patients were randomised to receive blinded upadacitinib 15 or 30 mg once daily (QD), or placebo for 24 weeks followed by upadacitinib 15 or 30 mg QD. After 56 weeks, patients were eligible to enter an open-label extension (OLE) in which they continued their assigned dose of upadacitinib. Efficacy and safety were assessed through 152 weeks. A subanalysis of patients with IR to tumour necrosis factor inhibitors (TNFis) was also conducted. Results In total, 450 patients entered the OLE and 358 completed 152 weeks of treatment. Improvements in efficacy outcomes observed at week 56, including the proportion of patients achieving: 20/50/70% improvement in American College of Rheumatology criteria, minimal disease activity, and 75/90/100% improvement in Psoriasis Area and Severity Index, were maintained through week 152. Efficacy outcomes in the TNFi-IR subgroup were similar to those reported in the overall population. Upadacitinib was well tolerated throughout long-term treatment, with no cumulative adverse effects observed through 152 weeks. Conclusion Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.