Efficacy and safety of upadacitinib in patients with psoriatic arthritis and exposure to one anti-TNF: post hoc analysis of SELECT-PsA 2
In brief
Upadacitinib achieves 58% ACR20 response versus 22% with placebo in TNF-exposed PsA
In patients who had failed one TNF inhibitor, upadacitinib 15 mg daily produced ACR20, ACR50, ACR70 and minimal disease activity rates of 58%, 38%, 22% and 24% at 24 weeks, far outpacing placebo, and these benefits persisted through three years. Efficacy was similar regardless of how long the prior TNF blocker had been used, and early pain relief predicted long-term disease control, with no new safety concerns observed.
- Journal
- RMD open (Q1)
- Published
- 27 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Laura C Coates, Philip Mease, Arthur Kavanaugh, Joseph F Merola, Marina Magrey, Thomas Iyile, et al.
- PMID
- 42660564
- DOI
- 10.1136/rmdopen-2025-006655
Why clinicians should know about it
- Picked for Dermatology (top studies of the week, 30 August 2026): Upadacitinib long‑term efficacy in PsA after TNFi
- Picked for Anatomy (top studies of the week, 30 August 2026): High-quality evidence in a top journal
- Picked for Rheumatology (top studies of the week, 30 August 2026): Upadacitinib 15 mg shows sustained efficacy in PsA after TNF‑i
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.