真实世界中司库奇尤单抗治疗中轴型脊柱关节炎的疗效及保留率：来自加拿大脊柱关节炎研究网络的研究结果。
Real-World Retention and Clinical Effectiveness of Secukinumab for Axial Spondyloarthritis: Results From the Canadian Spondyloarthritis Research Network.
机构信息
R.D. Inman, MD, D.D. Gladman, MD, Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, University of Toronto, Toronto, Ontario;
D. Choquette, MD, Institut de recherche en rhumatologie de Montréal, CHUM, Montréal, Quebec.
出版信息
J Rheumatol. 2023 May;50(5):634-640. doi: 10.3899/jrheum.220824. Epub 2023 Jan 15.
OBJECTIVE
Axial spondyloarthritis (axSpA) is a chronic, immune-mediated, inflammatory condition consisting of 2 clinical subsets: nonradiographic axSpA and ankylosing spondylitis, the latter having an estimated prevalence of 0.2% to 1% in Canada. Secukinumab (SEC) received Health Canada approval in 2016 for the treatment of adults with axSpA who have responded inadequately to conventional treatment, and has demonstrated efficacy and safety through extensive clinical trials. However, there is limited evidence on its real-world use in Canada. The objective of this study was to use the Canadian Spondyloarthritis (CanSpA) Research Network to describe real-world retention and effectiveness of SEC in the Canadian axSpA population.
METHODS
This was an observational cohort study of Canadian patients with axSpA aged 18 to 65 years within the CanSpA network who had received treatment with SEC. Patients were indexed on the first date of SEC initiation. Retention and clinical effectiveness were assessed at 12 months postindex. Clinical effectiveness was measured as the proportion in remission and change in disease activity using multiple clinical indices.
RESULTS
A total of 146 patients were included. Overall retention was estimated at 62.9%. Low disease activity (ie, Bath Ankylosing Spondylitis Disease Activity Index < 4) was achieved in 29.2% of patients, and 2% had achieved remission based on the Ankylosing Spondylitis Disease Activity Score. Bath Ankylosing Spondylitis Metrology Index scores improved by more than 60% from baseline to 12 months.
CONCLUSION
The results of this real-world study of Canadian patients with axSpA, one of the first of its kind, support the effectiveness of SEC for treatment of axSpA. The CanSpA network presents an opportunity to continue building and improving the real-world evidence base for treatment of Canadian patients with spondyloarthritis.
目的
中轴型脊柱关节炎（axSpA）是一种慢性、免疫介导的炎症性疾病，包括 2 种临床亚型：非放射学 axSpA 和强直性脊柱炎，后者在加拿大的估计患病率为 0.2%至 1%。司库奇尤单抗（SEC）于 2016 年获得加拿大卫生部批准，用于治疗对常规治疗反应不足的 axSpA 成年患者，并且通过广泛的临床试验证明了其疗效和安全性。然而，在加拿大，其实际应用的证据有限。本研究的目的是利用加拿大脊柱关节炎（CanSpA）研究网络，描述 SEC 在加拿大 axSpA 人群中的实际应用保留率和疗效。
方法
这是一项观察性队列研究，纳入了 CanSpA 网络中年龄在 18 至 65 岁之间的接受 SEC 治疗的 axSpA 加拿大患者。患者以 SEC 起始日期为索引日期。在索引后 12 个月评估保留率和临床疗效。临床疗效通过使用多个临床指标评估缓解率和疾病活动度变化来衡量。
结果
共纳入 146 例患者。总体保留率估计为 62.9%。29.2%的患者达到低疾病活动度（即 Bath 强直性脊柱炎疾病活动指数＜4），根据强直性脊柱炎疾病活动评分，有 2%的患者达到缓解。Bath 强直性脊柱炎计量学指数评分从基线到 12 个月改善超过 60%。
结论
这项加拿大 axSpA 患者真实世界研究的结果，是同类研究中的首例，支持 SEC 治疗 axSpA 的有效性。CanSpA 网络为继续建立和完善加拿大脊柱关节炎患者治疗的真实世界证据基础提供了机会。
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