EFFICACY OF UPADACITINIB ON PSORIATIC ARTHRITIS WITH AXIAL INVOLVEMENT DEFINED BY INVESTIGATOR ASSESSMENT AND PRO-BASED CRITERIA: RESULTS FROM TWO PHASE 3 STUDIES
Authors: Xenofon Baraliakos et al.
Axial involvement in psoriatic arthritis (PsA) has a clear impact on quality of life. It is important to assess the effect of drugs not only for peripheral joint disease but also for axial involvement. In the post-hoc analysis of 2 clinical phase 3 trials with Upadacitinib (SELECT PsA 1 and 2), the efficacy of this JAKi on axial symptoms was assessed in patients with PsA. Axial involvement at baseline was determined by investigator assessment of duration and character of back pain, age at onset and previous imaging. Spinal active disease was defined as BASDAI ≥4 and BASDAI question 2 ≥4. 31–34% of the patients had axial involvement as defined by investigator. 23–27% met the combined criteria including BASDAI active disease. At 24 weeks Upadacitinib showed greater efficacy compared to placebo for all assessed endpoints. In the SELECT PsA 1 study Upadacitinib showed a numerically higher response compared with Adalimumab across all BASDAI and ASDAS endpoints, ASDAS clinically important improvement was significantly higher with Upadacitinib versus Adalimumab.
This post hoc analysis of published clinical trials is important as it used a more stringent definition of axial involvement than previous analyses in clinical trials, which were based on investigator assessment alone. The efficacy of Upadacitinib for axial disease manifestations in PsA is demonstrated to be superior to placebo and at least comparable with Adalimumab. Thus, Upadacitinib is a therapeutic option for patients with PsA and axial involvement.