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类风湿关节炎患者中按血清状态划分的改善病情抗风湿药的真实世界治疗效果

Real-World Treatment Effectiveness of Disease-Modifying Antirheumatic Drugs by Serostatus Among Patients With Rheumatoid Arthritis.

作者信息

Jin Yinzhu, Liu Jun, Desai Rishi J, Kim Seoyoung C

机构信息

Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

出版信息

ACR Open Rheumatol. 2023 Nov;5(11):571-580. doi: 10.1002/acr2.11548. Epub 2023 Sep 29.

Abstract

OBJECTIVE

The objective of this study was to compare the clinical effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) among seropositive versus seronegative patients with rheumatoid arthritis (RA) in a real-world setting.

METHODS

We used Optum's deidentified Clinformatics Data Mart Database (January 1, 2004, to March 31, 2021) linked with outpatient laboratory test results. The study population was adult patients with RA who initiated a bDMARD or JAKi. The index date was the dispensing of the first-ever study drug. At least 1-year continuous enrollment before and after the index date was required. Disenrollment due to death after the index date was allowed. Serostatus was defined using laboratory test results or the International Classification of Diseases, 10th Revision code M05x or M06.0x any time prior to the index date. Treatment effectiveness was measured based on a claims-based composite endpoint at 1-year post index, including nonoccurrence of any of the following: addition of conventional synthetic DMARDs, addition of or switching to new bDMARDs/JAKi, initiation of glucocorticoids, increased glucocorticoid dose, or death. Log-binomial regression models were constructed to estimate the risk ratio (RR) with 95% confidence interval (CI) comparing seropositive patients with seronegative patients, adjusting for more than 60 baseline covariates.

RESULTS

We identified a total of 7813 seropositive patients and 4202 seronegative patients. The mean (±SD) age was 56.7 (±14.0) years; 77.9% were female. The risk of 1-year treatment effectiveness was 70.2% among seropositive patients and 69.8% among seronegative patients. The adjusted RR (95% CI) was 1.00 (0.98-1.02).

CONCLUSION

In this real-world cohort study, seropositive and seronegative patients with RA had similar 1-year treatment effectiveness after initiating a bDMARD/JAKi.

摘要

目的

本研究的目的是在现实环境中比较生物性抗风湿药物(bDMARDs)或 Janus 激酶抑制剂(JAKi)在血清阳性与血清阴性类风湿关节炎(RA)患者中的临床疗效。

方法

我们使用了 Optum 的去识别化临床信息数据集市数据库(2004 年 1 月 1 日至 2021 年 3 月 31 日),并与门诊实验室检测结果相关联。研究人群为开始使用 bDMARD 或 JAKi 的成年 RA 患者。索引日期为首次使用研究药物的配药日期。索引日期前后至少需要连续登记 1 年。允许在索引日期后因死亡而退出研究。血清状态根据索引日期前任何时间的实验室检测结果或国际疾病分类第 10 版代码 M05x 或 M06.0x 定义。治疗效果根据索引日期后 1 年基于索赔的复合终点进行测量,包括未出现以下任何情况:添加传统合成 DMARDs、添加或换用新的 bDMARDs/JAKi、开始使用糖皮质激素、增加糖皮质激素剂量或死亡。构建对数二项回归模型以估计风险比(RR)及 95%置信区间(CI),比较血清阳性患者与血清阴性患者,并对 60 多个基线协变量进行调整。

结果

我们共识别出 7813 例血清阳性患者和 4202 例血清阴性患者。平均(±标准差)年龄为 56.7(±14.0)岁;77.9%为女性。血清阳性患者 1 年治疗有效的风险为 70.2%,血清阴性患者为 69.8%。调整后的 RR(95%CI)为 1.00(0.98 - 1.02)。

结论

在这项现实队列研究中,血清阳性和血清阴性 RA 患者在开始使用 bDMARD/JAKi 后 1 年的治疗效果相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/10642251/9555f0b98891/ACR2-5-571-g001.jpg

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