Real-World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Canadian Patients with Axial Spondyloarthritis: Interim Results from the Upstand Study

Objectives To prospectively assess the real-world effectiveness of upadacitinib (UPA) on early and sustained pain control in Canadian patients with axial spondyloarthritis (axSpA) participating in the UPSTAND study. Methods UPSTAND ( NCT04846244 ) is a 12-month, multi-country observational study in adult patients with axSpA for whom, prior to and independent of the study enrollment, the treating physician has decided to prescribe UPA, per local label. Patients had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and total back pain scores ≥4 at baseline and an inadequate response or intolerance/contraindication to NSAIDs. Co-primary endpoints are 1) total spinal pain score <4 and ≥2unit improvement from baseline at Week 12, and 2) maintenance up to Week 52 (not available). Secondary endpoint measures include patient assessment of spinal, total back, and nocturnal back pain, painDETECT for capturing neuropathic pain, Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) for capturing nociplastic pain, Ankylosing Spondylitis Disease Activity Score (ASDAS), and BASDAI. This interim analysis reports data through 20-Jun-2024; at cutoff, all patients had completed at least the Week 12 visit. Results are presented as observed cases using descriptive statistics. Results A total of 71 Canadian patients were included in this analysis (mean age: 51.3 years [SD: 12.5]; female gender: 52.1%; mainly White [90.1%] or Asian [8.5%]). Most patients had radiographic axSpA (97.1%) and 70.1% experienced symptoms of axSpA for ≥10 years (mean duration 18.3 years). The primary endpoint of a total spinal pain score <4 and a ≥2-point improvement from baseline at Week 12 was achieved by 31.7% (n/N = 13/41) of patients with a baseline score ≥4. The mean total (7.0 to 5.3) and nocturnal (6.6 to 5.0) back pain decreased rapidly over the first 2 weeks of treatment with further reduction up to Week 52 (Figure 1A/B). Treatment with UPA reduced both painDETECT (12.8 to 9.0) and WPI (7.6 to 6.1) from baseline to Week 52 (Figure 1C). Similarly, improvement in axSpA composite measures of disease activity was observed using the ASDAS and BASDAI (Figure 1D). UPA was generally well-tolerated, and its safety profile was consistent with observations made across randomized clinical trials (RCTs). Figure 1. Effectiveness of Upadacitinib to Improve Pain and Disease Severity in Axial Spondyloarthritis Conclusion These interim results show that Canadian patients with axSpA treated with UPA in the real-world setting have rapid and consistent improvement in pain (including measures reflecting neuropathic and nociplastic components) and in disease activity. This improvement in pain and disease control is consistent with data from RCTs.