Upadacitinib for the Treatment of Active Non-radiographic Axial Spondyloarthritis (SELECT-AXIS 2): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Lancet 2022 doi: 10.1016/S0140-6736(22)01212-0

Upadacitinib significantly improved the signs and symptoms of nr-axSpA compared with placebo at Week 14 in this investigation. Prior to this, upadacitinib had been shown to be effective in patients with AS. This study aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.

To achieve this, patients were stratified and randomly assigned (1:1) to receive oral upadacitinib 15 mg once daily or placebo using interactive response technology. Overall upadacitinib was well tolerated, with treatment-emergent adverse events occurring at similar rates between groups. The collective findings support the potential of upadacitinib as a new therapeutic option in patients with active nr-axSpA.