Efficacy and safety of upadacitinib in patients with psoriatic arthritis and exposure to one anti-TNF: post hoc analysis of SELECT-PsA 2.

OBJECTIVE: This post hoc analysis of the SELECT-PsA 2 study evaluated long-term efficacy and safety of upadacitinib 15 mg once daily in patients with psoriatic arthritis (PsA) and exposure to one prior tumour necrosis factor inhibitor (TNFi). METHODS: Patients were randomised to upadacitinib 15 mg once daily or placebo (switched to upadacitinib at week 24). Efficacy assessments 20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), minimal disease activity (MDA), 75%/90% improvement in Psoriasis Area Severity Index Score (PASI75/90), pain) were conducted through 152 weeks. Analyses evaluated the impact of prior TNFi exposure duration, skin improvement by location and early pain response as a predictor of long-term MDA. Safety was reported as treatment-emergent adverse events through week 152. RESULTS: Of 195 patients with exposure to one prior TNFi, 90 and 105 were randomised to upadacitinib 15 mg once daily and placebo, respectively. More patients randomised to upadacitinib 15 mg once daily versus placebo achieved ACR20 (57.8% vs 21.9%), ACR50 (37.8% vs 9.5%), ACR70 (22.2% vs 0%) and MDA (24.4% vs 2.9%) at week 24. Responses were maintained or improved through week 152. Patients who switched from placebo at week 24 achieved sustained PASI75/90 responses across different anatomical regions. Efficacy was generally similar regardless of the duration of prior TNFi exposure in sensitivity and tertile analyses. Lower pain scores at weeks 2 and 12 predicted MDA achievement at week 152. No new safety signals were identified. CONCLUSION: Upadacitinib 15 mg once daily demonstrated sustained efficacy and an acceptable safety profile in patients with PsA and exposure to one prior TNFi, irrespective of the duration of previous TNFi exposure.