Phase III SELECT-PsA 1 trial: 5-year follow-up of upadacitinib in PsA

Results from the long-term extension of the randomized, phase III SELECT-PsA 1 trial (NCT03104400), evaluating upadacitinib vs adalimumab in patients with active psoriatic arthritis (PsA) and an inadequate response to non-biologic disease-modifying antirheumatic drugs (non-bDMARD-IR), were published in Rheumatology and Therapy by McInnes et al.  

Key data: Of 1,704 patients enrolled in SELECT-PsA 1,983 completed treatment at Week 260. The proportions of patients attaining ≥20% improvement in American College of Rheumatology criteria (ACR20; 90.3% and 86.6%), ACR50 (71.8% and 71.2%), and ACR70 (47.1% and 48.4%) responses were maintained through Week 260 with upadacitinib 15 mg and 30 mg, respectively, and were generally comparable to adalimumab (86.3%, 66.4%, and 44.7%, respectively). Psoriasis Area and Severity Index (PASI) responses at Week 260 were similar between patients receiving upadacitinib 15 mg, upadacitinib 30 mg, and adalimumab (PASI75, 78.4%, 79.8%, and 85.2%; PASI90, 67.2%, 65.9%, and 71.9%; PASI100, 47.0%, 52.7%, and 51.1%). At Week 260, 58.9%, 62.5%, and 55.0% of patients receiving upadacitinib 15 mg, upadacitinib 30 mg, and adalimumab, respectively, demonstrated minimal disease activity (MDA). The safety profile of upadacitinib was consistent with observations at 104 and 152 weeks. Higher rates of herpes zoster, non-melanoma skin cancer (NMSC), creatine kinase (CPK) elevation, and infections were observed with upadacitinib relative to adalimumab. No new safety signals were identified with prolonged upadacitinib treatment. 

Key learning: In the 5-year analysis of SELECT-PsA 1, upadacitinib demonstrated sustained efficacy across multiple PsA domains, with a safety profile consistent with that observed throughout the trial. These findings support the long-term benefit–risk profile of upadacitinib in patients with PsA and non-bDMARD-IR.