1. Significantly more patients in the upadacitinib group achieved ASAS40 response at week 14 compared to the placebo group.
2. Quality-of-life measures and subjective back pain were improved with upadacitinib.
Evidence Rating Level: 1 (Excellent)
Study Rundown: First-line treatment for non-radiographic axial spondyloarthritis includes non-steroidal anti-inflammatory drugs (NSAIDs) and biologic disease-modifying anti-rheumatic drugs (bDMARDs). Upadacitinib, a Janus kinase (JAK) inhibitor, has been reported to be effective for ankylosing spondylitis, however, research on non-radiographic axial spondyloarthritis is limited. This randomized controlled trial aimed to assess the safety and efficacy of upadacitinib in patients with non-radiographic axial spondyloarthritis. The primary outcome was the proportion of patients with Assessment of Spondylarthritis international Society (ASAS40) response, defined as ≥40% response in 3 of 4 domains: disease activity, physical function, total spine pain, and spinal stiffness/inflammation, by week 14. Key secondary outcomes included change in Ankylosing Spondylitis Disease Activity Score (ASDAS) based on inflammatory markers. According to study results, upadacitinib resulted in significant improvements in the primary outcome of ASAS40 response compared to placebo. In addition, patient measures of quality of life and total back pain were improved with upadacitinib. This study was strengthened by a large sample size with individuals from various countries, increasing its generalizability.
Relevant Reading: Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis
In-depth [randomized-controlled trial]: Between Nov 26, 2019, and May 20, 2021, 1352 patients were screened for eligibility across 113 sites in 23 countries. Included were patients with non-radiographic MRI-confirmed axial spondyloarthritis or those with elevated C-reactive protein (CRP). Altogether, 313 patients (156 in upadacitinib and 157 in placebo) were included in the final analysis. The primary outcome of ASAS40 response rate at week 14 was significantly higher in the upadacitinib group than placebo (70 of 156 [45%] vs. 35 of 157 [23%], 95% confidence interval [CI] 12-32, p<0.0001). A similar pattern was noted in additional measures of disease activity such as ASDAS low activity (p<0.0001) and ASAS partial remission (p=0.0035). In addition, at week 14, those in the upadacitinib group reported significant improvements in quality-of-life scores (p<0.0001) and total back pain (p=0.0004). The proportion of serious adverse events was comparable in both groups (3% upadacitinib vs. 1% placebo) with only 5 of 156 patients in the upadacitinib groups having neutropenia. There were no treatment-related deaths. Overall, findings from this study suggest that upadacitinib was both safe and effective in treatment of non-radiographic axial spondyloarthritis.
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