P185 Real-world effectiveness of upadacitinib on early pain control in patients with axial spondyloarthritis: interim results from the UPSTAND observational study

Abstract Background/Aims Upadacitinib has demonstrated efficacy and safety in axSpA patients in late phase clinical trials. Here we present interim findings from the UPSTAND study evaluating early and sustained pain control in axSpA patients treated with upadacitinib. Methods UPSTAND is a 12-month, multi-country observational study evaluating the real-world effectiveness of upadacitinib on pain in adult axSpA patients who’d experienced an inadequate response to ≥ 2 NSAIDs.The co-primary endpoints are 1) total spinal pain score 4 and a ≥ 2-point improvement from baseline at week 12, evaluated in patients with a total spinal pain score ≥4 at baseline and 2) maintenance of this response at week 52. Total spinal pain is defined as the mean of total back pain and nocturnal back pain measured via numeric rating scale (0-10). Additional endpoints included improvements in neuropathic pain and nociplastic pain assessed by painDETECT and Widespread Pain Index (WPI) score respectively and low disease activity (LDA), inclusive of inactive disease (ASDAS 2.1). Safety was evaluated in all patients who received upadacitinib and reported as events (E) per 100 patient-years (E/100 PY) and 95% confidence intervals. Results 660 patients (96% with r-axSpA) enrolled in the study and received ≥1 dose of upadacitinib. At week 12, a total spinal pain score 4 and ≥2-point reduction from baseline, in patients with a total spinal pain score ≥4 at baseline was achieved by 41.9% of patients (n/N=156/372). Patients treated with upadacitinib experienced reductions in total and nocturnal back pain from baseline (total mean: 6.9, N = 621; nocturnal mean: 6.4, N = 621) to week 12 (total mean: 4.4, N = 433; nocturnal mean: 4.0, N = 432). Daily measures of total and nocturnal back pain over the first 2 weeks showed treatment with upadacitinib led to a quickand consistent reduction in pain, with reductions as early as day 1. 35.3% of patients achieved ASDAS LDA at week 12 (n/N=88/249) and 46.2% at week 24 (n/N=91/197). PainDETECT scores (baseline mean: 13.4, N = 615) and WPI scores (baseline mean: 6.8, N = 613) reduced at week 12 (painDETECT: 9.6, N = 503; WPI: 5.0, N = 505), with further reductions at week 24 (painDETECT: 8.7, N = 399; WPI: 4.6, N = 399). There were 35 serious treatment emmergent adverse events (TEAEs) (7.0 E/100 PY), 84 TEAEs leading to discontinuation of upadacitinib (16.7 E/100 PY), and one non-treatment emergent death occurring 30 days after the last dose. COVID-19 (41, 8.2 E/100 PY) and upper respiratory tract infection (27, 5.4 E/100 PY) were the TEAs observed most frequently. One event of deep vein thrombosis and no events of MACE were reported. Conclusion In an ongoing observational study, patients with axSpA treated with upadacitinib experienced quick and consistent reductions in spinal pain, including nocturnal pain, demonstrating real-world effectiveness of upadacitinib to deliver early pain control, consistent with clinical trial data. Disclosure D. Poddubnyy: Consultancies; Has received consulting fees from AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, MoonLake, Novartis, Pfizer, Samsung Bioepis and UCB. Honoraria; Has received speaker honoraria from AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB. Grants/research support; Has received research grants from AbbVie, Lilly, MSD, Novartis and Pfizer. D. Vassilopoulos: Consultancies; Has received consulting fees from AbbVie, Eli Lilly, GSK, Janssen, Novartis, Pfizer, Sobi and UCB. Grants/research support; (Through the Special Account for Research Grants-S.A.R.G., National and Kapodistrian University of Athens, Athens, Greece)Has received research grants from AbbVie, Eli Lilly, Genesis-Pharma, Pfizer and UCB. A. Tran: Consultancies; Has received consulting fees from AbbVie, Eli Lilly, Pfizer, Novartis, Janssen and UCB. Honoraria; Has received speaker honoraria from Janssen and Pfizer. Grants/research support; Has received a research grant from AbbVie. A. Moltó: Consultancies; Has received consulting fees from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB and Viatris. Grants/research support; Has received research grants from AbbVie, Biogen and UCB. V. Navarro-Compán: Consultancies; Has received consulting fees from AbbVie, Alfasigma, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer and UCB Pharma. Honoraria; Has received speaking fees from AbbVie, Alfasigma, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Grants/research support; Has received research grants from AbbVie and Novartis. T. Gao: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. C.D. Saffore: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. J. Urbanik: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. I. Lagunes: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. B. Parikh: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. C. Hansell: Corporate appointments; Is an employee of AbbVie. Shareholder/stock ownership; May hold AbbVie stock or stock options. P. Mease: Consultancies; Has received consulting fees from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer and UCB. Honoraria; Has received speaker fees from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer and UCB. Grants/research support; Has received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer and UCB.