乌帕替尼治疗加拿大类风湿关节炎患者的真实世界有效性：前瞻性观察性CLOSE-UP研究的中期结果
Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study.
作者信息
Bessette Louis, Chan Jonathan, Chow Andrew, Lisnevskaia Larissa, Richard Nicolas, Fournier Pierre-Andre, Liazoghli Dalinda, Girard Tanya, Haaland Derek
机构信息
Centre de L'ostéoporose et de Rhumatologie de Québec (CORQ), Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO), Université de Laval, 100-1200 Avenue Germain-Des-Prés, Quebec, QC, G1V 3M7, Canada.
University of British Columbia, Vancouver, BC, Canada.
出版信息
Rheumatol Ther. 2024 Jun;11(3):563-582. doi: 10.1007/s40744-024-00651-8. Epub 2024 Mar 11.
INTRODUCTION
Upadacitinib (UPA), a selective, reversible, oral Janus kinase (JAK)-1 inhibitor, was approved in 2019 in Canada for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). This phase 4 prospective study aimed to characterise the effectiveness of UPA in the real-world population of patients with RA.
METHODS
Adults with RA who initiated treatment with once daily UPA (15 mg) and enrolled in the Canadian Real-Life post-marketing Observational Study assessing the Effectiveness of UPadacitinib for treating rheumatoid arthritis (CLOSE-UP) and who completed a 6-month assessment as of 28 February 2023 were included. The primary endpoint of the CLOSE-UP study is the proportion of patients achieving a Disease Activity Score-28 Joint Count C-reactive protein (DAS28-CRP) < 2.6 at 6 months. Data was collected at routine visits. Data analysed and summarised descriptively for the overall interim population and for subgroups based on prior therapy included remission or low disease activity, patient-reported outcomes (PROs), and adverse events.
RESULTS
A total of 392 patients were included in the interim analysis. Overall, 63.5% (191/301) of patients achieved a DAS28-CRP score < 2.6 at month 6, with similar rates observed for all subgroups analysed according to prior therapy including those with prior JAK inhibitor exposure (range 57.4-71.0%), and in patients who received UPA monotherapy (71.6% [48/67]). Early (month 3) and sustained improvements up to 6 months were observed for all PROs. The safety profile was consistent with previous reports.
CONCLUSION
Real-world improvements in disease activity and PROs in response to UPA treatment were consistent with clinical trial data across a range of Canadian patients with prior therapy exposure and with UPA monotherapy, with an overall favourable benefit-risk profile.
TRIAL REGISTRATION
NCT04574492.
简介
乌帕替尼（UPA）是一种选择性、可逆的口服 Janus 激酶（JAK）-1 抑制剂，于 2019 年在加拿大获批用于治疗中度至重度活动性类风湿关节炎（RA）成人患者。这项 4 期前瞻性研究旨在描述乌帕替尼在 RA 真实世界患者群体中的有效性。
方法
纳入了开始每日一次服用乌帕替尼（15 mg）治疗并参加加拿大上市后真实世界观察性研究“评估乌帕替尼治疗类风湿关节炎的有效性（CLOSE-UP）”且截至 2023 年 2 月 28 日完成 6 个月评估的 RA 成人患者。CLOSE-UP 研究的主要终点是在 6 个月时疾病活动评分-28 关节计数 C 反应蛋白（DAS28-CRP）<2.6 的患者比例。在常规访视时收集数据。对总体中期人群以及根据既往治疗情况划分的亚组的数据进行分析，并对缓解或低疾病活动度、患者报告结局（PROs）和不良事件进行描述性总结。
结果
共有 392 例患者纳入中期分析。总体而言，63.5%（191/301）的患者在第 6 个月时 DAS28-CRP 评分<2.6，根据既往治疗情况分析的所有亚组，包括既往接受过 JAK 抑制剂治疗的患者（范围为 57.4-71.0%）以及接受乌帕替尼单药治疗的患者（71.6% [48/67]），观察到的比例相似。所有 PROs 在早期（第 3 个月）和长达 6 个月时均有持续改善。安全性概况与既往报告一致。
结论
在加拿大一系列既往接受过治疗的患者以及接受乌帕替尼单药治疗的患者中，乌帕替尼治疗后疾病活动度和 PROs 的真实世界改善情况与临床试验数据一致，总体获益风险状况良好。
试验注册
NCT04574492。
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