POS0891 REAL-WORLD EFFECTIVENESS OF UPADACITINIB ON EARLY PAIN CONTROL IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: INTERIM RESULTS FROM THE UPSTAND OBSERVATIONAL STUDY

Background: Pain is the most common and bothersome symptom in axSpA and can be multifaceted, being attributed to inflammation (nociceptive), peripheral nervous system damage (neuropathic), or altered central nervous system pain modulation/central sensitization (nociplastic), all of which significantly impact patients' quality of life [1]. Upadacitinib (UPA), an oral JAK inhibitor (JAKi), has demonstrated efficacy and safety across the axSpA spectrum in multiple late phase clinical trials [2–4]. However, there is limited real-world evidence of the effectiveness of UPA on pain control. Here we present interim findings from patients who completed at least a week 12 visit from the UPSTAND study evaluating early and sustained pain control. Objectives: Here we present interim findings from patients who completed at least a week 12 visit from the UPSTAND study evaluating early and sustained pain control. Methods: UPSTAND (NCT04846244) is a 12-month, multi-country observational study evaluating the real-world effectiveness of UPA on pain in patients with axSpA. Enrolled patients were ≥ 18 years, diagnosed with axSpA, experienced an inadequate response to ≥ 2 NSAIDs, and were prescribed UPA prior to and independent of study enrollment in routine practice according to local label and reimbursement guidelines. Patients with prior use of JAKis or active symptoms of fibromyalgia as per clinical diagnosis were excluded. 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 among week 12 responders 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 to 10). Data are presented from an interim analysis through June 20th, 2024, after all patients completed at least the week 12 visit. Additional endpoints included improvements in additional pain types (neuropathic pain and nociplastic pain as 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 at least one dose of UPA and reported as events (E) per 100 patient-years (E/100 PY) and 95% confidence intervals. Results: A total of 660 patients (96% with r-axSpA) enrolled in the study and received at least one dose of UPA. At week 12, the primary endpoint of a total spinal pain score < 4 and ≥ 2-point reduction from baseline, evaluated in patients with a total spinal pain score ≥ 4 at baseline was achieved by 41.9% of patients (n/N = 156/372) (Figure 1A). Patients treated with UPA experienced clinically meaningful improvements in total back pain from baseline (6.9, N=621) to week 12 (4.4, N=433) and in nocturnal back pain from baseline (6.4, N=621) to week 12 (4.0, N=432) (Figure 1B). Additional improvements in both total back pain and nocturnal back pain were observed in those patients who completed a week 24 visit prior to the interim analysis. Daily measures of total back pain and nocturnal back pain over the first 2 weeks showed that treatment with UPA led to a rapid and consistent reduction in pain, with reductions observed as early as day 1 (Figure 1C, D). ASDAS LDA was achieved by 35.3% of patients at week 12 (n/N = 88/249) and 46.2% of patients at week 24 (n/N = 91/197) (Figure 1F). Reductions in painDETECT score (baseline mean: 13.4, N=615) and WPI score (baseline mean: 6.8, N=613) were observed at week 12 (painDETECT: 9.6, N=503; WPI: 5.0, N=505), with further reductions noted at week 24 (painDETECT: 8.7, N=399; WPI: 4.6, N=399) (Figure 1E). There were 35 serious TEAEs (7.0 E/100 PY), 84 TEAEs leading to discontinuation of UPA (16.7 E/100 PY), and one non-treatment emergent death occurring > 30 days after the last dose (Table 1). Additionally, all TEAEs occurring in ≥ 1.4 E/100 PY are reported, with COVID-19 (41, 8.2 E/100 PY) and upper respiratory tract infection (27, 5.4 E/100 PY) 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 UPA experienced rapid and consistent reductions in spinal pain, including nocturnal pain, demonstrating the real-world effectiveness of UPA to deliver early pain control, consistent with clinical trial data. REFERENCES: [1] Navarro-Compán V, et al. Ann Rheum Dis. 2021;80:1511-21. [2] van der Heijde D, et al. Lancet. 2019;394:2108-17. [3] van der Heijde D, et al. Ann Rheum Dis. 2022;81:1515-23. [4] Deodhar A, et al. Lancet. 2022;400:369-79. Acknowledgements: AbbVie funded this study (NCT04846244) and participated in the study design, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. The authors would like to thank Fabiana Ganz, a former employee of AbbVie, and Patrick Zueger of AbbVie for their contributions to the study design. Medical writing support was provided by Kathleen E. Gordon, PhD of AbbVie. Disclosure of Interests: Denis Poddubnyy has received speaker honoraria from AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB, consulting fees from AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, MoonLake, Novartis, Pfizer, Samsung Bioepis and UCB, research grants from AbbVie, Lilly, MSD, Novartis and Pfizer, Dimitrios Vassilopoulos has received consulting fees from AbbVie, Eli Lilly, GSK, Janssen, Novartis, Pfizer, Sobi and UCB (through the Special Account for Research Grants-S.A.R.G., National and Kapodistrian University of Athens, Athens, Greece), research grants from AbbVie, Eli Lilly, Genesis-Pharma, Pfizer, and UCB, Ai Tran has received speaker honoraria from Janssen and Pfizer, consulting fees from AbbVie, Eli Lilly, Pfizer, Novartis, Janssen, and UCB, a research grant from AbbVie, Anna Moltó has received consulting fees from AbbVie, Amgen, Biogen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB and Viatris, research grants from AbbVie, Biogen and UCB, Victoria Navarro-Compán has received speaking fees from AbbVie, Alfasigma, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer, UCB Pharma, consulting fees from AbbVie, Alfasigma, Eli Lilly, Galapagos, MoonLake, MSD, Novartis, Pfizer, UCB Pharma, research grants from AbbVie and Novartis, Tianming Gao is an employee of AbbVie and may hold stock or options, Christopher D Saffore is an employee of AbbVie and may hold stock or options, Jamie Urbanik is an employee of AbbVie and may hold stock or options, Ivan Lagunes is an employee of AbbVie and may hold stock or options, Bhumik Parikh is an employee of AbbVie and may hold stock or options, Philip J. Mease has received speaker fees from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB, consulting fees from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB, research grants from AbbVie, Acelyrin, Amgen, Bristol Myers, Inmagene, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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