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类风湿关节炎患者生物制剂转换的疾病活动度阈值:来自美国大型队列的经验。

Thresholds in disease activity for switching biologics in rheumatoid arthritis patients: experience from a large U.S. cohort.

机构信息

University of Alabama at Birmingham, 35294, USA.

出版信息

Arthritis Care Res (Hoboken). 2011 Dec;63(12):1672-9. doi: 10.1002/acr.20643.

Abstract

OBJECTIVE

To examine the threshold in disease activity associated with switching biologic treatment regimens in rheumatoid arthritis (RA) patients in real-world clinical practice.

METHODS

Using data from a prospective observational North American cohort of RA patients through December 30, 2009, patients who initiated a new anti-tumor necrosis factor α (anti-TNFα) agent with ≥6 months of followup were identified. Patients were classified as switchers or maintainers depending on whether they continued their anti-TNF treatment or switched (including discontinuation) within 12 months. Level of disease activity measured by the Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints (DAS28) at the time of the switch (corresponding followup visit for maintainers) was examined and random-effect multivariable logistic regression was used to adjust for covariates.

RESULTS

Mean age and RA duration among 1,549 eligible patients were 56.1 and 9.6 years, respectively, 80% were women, 62% were initiating their first biologic, and 30% were initiating their second biologic. At the time of the switch, the median DAS28 and CDAI score were 3.1 and 8.4 among maintainers and 4.0 and 15.2 among switchers, respectively. Maintainers also experienced a greater amount of reduction in disease activity compared with switchers (CDAI: -7.7 versus -2.3, DAS28: -1.1 versus -0.3). The threshold to switch decreased over calendar time, with the greatest amount of reduction observed among patients with moderate disease activity.

CONCLUSION

On average, physicians and patients were willing to continue biologic treatment for patients who were at or near low disease activity. The threshold to switch decreased over time, especially among partial responders.

摘要

目的

在真实世界的临床实践中,研究与类风湿关节炎(RA)患者转换生物治疗方案相关的疾病活动阈值。

方法

利用 2009 年 12 月 30 日前一项前瞻性观察性北美 RA 患者队列的数据,确定了开始使用新的抗肿瘤坏死因子α(anti-TNFα)药物且随访时间≥6 个月的患者。根据患者是否在 12 个月内继续使用抗 TNF 治疗或转换(包括停药),将其分为转换组或维持组。在转换时(维持组为相应的随访就诊时)测量疾病活动程度,使用临床疾病活动指数(CDAI)和 28 个关节疾病活动评分(DAS28)进行评估,并采用随机效应多变量逻辑回归来调整协变量。

结果

在 1549 名符合条件的患者中,平均年龄和 RA 病程分别为 56.1 岁和 9.6 年,分别为 80%为女性,62%为首次使用生物制剂,30%为第二次使用生物制剂。在转换时,维持组的中位数 DAS28 和 CDAI 评分分别为 3.1 和 8.4,转换组分别为 4.0 和 15.2。与转换组相比,维持组的疾病活动度也有更大程度的降低(CDAI:-7.7 比-2.3,DAS28:-1.1 比-0.3)。随着时间的推移,转换的阈值降低,中度疾病活动患者的降幅最大。

结论

平均而言,医生和患者愿意继续为接近或处于低疾病活动度的患者使用生物制剂治疗。随着时间的推移,转换的阈值降低,尤其是在部分缓解者中。

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