Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-03-11 DOI:10.1007/s40744-024-00651-8

Louis Bessette, Jonathan Chan, Andrew Chow, Larissa Lisnevskaia, Nicolas Richard, Pierre-Andre Fournier, Dalinda Liazoghli, Tanya Girard, Derek Haaland

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引用次数: 0

Abstract

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.

Abstract Image

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奥帕他替尼对加拿大类风湿关节炎患者治疗的实际效果：前瞻性观察CLOSE-UP研究的中期结果

简介：2019年，加拿大批准帕达替尼（UPA）作为一种选择性、可逆的口服Janus激酶（JAK）-1抑制剂，用于治疗中度至重度活动性类风湿性关节炎（RA）成人患者。这项4期前瞻性研究旨在描述UPA在现实世界RA患者群体中的疗效。方法纳入开始接受每日一次UPA（15毫克）治疗的成人RA患者，这些患者参加了加拿大UPadacitinib治疗类风湿关节炎疗效的真实上市后观察性研究（CLOSE-UP），并在2023年2月28日前完成了6个月的评估。CLOSE-UP研究的主要终点是在6个月时达到疾病活动度评分-28关节计数C反应蛋白（DAS28-CRP）< 2.6的患者比例。数据在常规就诊时收集。对总体中期人群和基于既往治疗的亚组进行了数据分析和描述性总结，包括缓解或低疾病活动度、患者报告结果（PROs）和不良事件。总体而言，63.5%（191/301）的患者在第6个月时DAS28-CRP评分达到2.6分，根据既往治疗情况分析的所有亚组中，包括既往接受过JAK抑制剂治疗的患者（57.4%-71.0%）和接受UPA单药治疗的患者（71.6% [48/67]），都观察到了相似的比率。所有PRO指标均出现了早期（第3个月）和持续6个月的改善。结论UPA治疗对疾病活动性和PROs的实际改善与临床试验数据一致，适用于既往接受过治疗的一系列加拿大患者，也适用于UPA单药治疗，总体收益风险状况良好。

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies. 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