Department of Internal Medicine III-Nephrology, Rheumatology, Endocrinology, Faculty of Medicine and Dentistry, Palacký University in Olomouc, University Hospital Olomouc, I.P. Pavlova 6, 772 00, Olomouc, Czech Republic,
Clin Rheumatol. 2013 Oct;32(10):1451-8. doi: 10.1007/s10067-013-2303-6. Epub 2013 Jun 2.
The Czech national registry ATTRA collects data from patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and juvenile idiopathic arthritis, treated with the biologic drugs. ATTRA is a prospective centralized computerized registry of patients with a focus on efficacy, safety, and quality of life data. Abatacept is approved as a second-line agent which can be prescribed after a failure of at least one TNF-alfa inhibitor. Data of patients treated with abatacept has been collected since 2008. A statistical analysis of the group of RA patients treated with abatacept was performed recently. ATTRA registered 162 patients with RA treated with abatacept, the mean age 51.0 ± 12.2 (median 53.1, 19-74 years), the mean duration of the disease was 14 ± 9.1, median 11.3 years (0-41). One hundred thirty patients (80.2 %) were female. The mean DAS28 was at week 0, 5.9 ± 1.1, at week 16, 4.1 ± 1.4, at week 24, 3.8 ± 1.2, at week 36, 3.6 ± 1.3, and at week 52, 3.5 ± 1.2. DAS28 remission was achieved at week 16 in 15.8 %, at week 24 in 10 %, at week 36 in 20.9 %, and at week 2 in 20.8 % of patients. Of those patients with a DAS28 <2.6 (remission) at week 16, 58.3 % remained in remission at the week 52. Of those patients with DAS28 >5.1 (high disease activity) at the week 16, only 41.7 % had DAS >5.1 at week 52. One year on treatment survival was 82 %. Altogether 50 non-serious adverse events (AE) were reported in 36 patients (22 %) and 11 serious AE in 10 patients (6 %) with the most common being infections (31) and skin rashes (5). Just one non-serious allergic reaction was reported. Data from the ATTRA registry confirms a good overall efficacy and safety profile and a very good on drug survival with abatacept.
捷克国家注册中心 ATTRA 从类风湿关节炎、强直性脊柱炎、银屑病关节炎和幼年特发性关节炎患者中收集数据,这些患者接受生物药物治疗。ATTRA 是一个集中化的前瞻性患者登记处,重点关注疗效、安全性和生活质量数据。阿巴西普被批准为二线药物,可在至少一种 TNF-α 抑制剂治疗失败后使用。自 2008 年以来,ATTRA 一直在收集接受阿巴西普治疗的患者数据。最近对接受阿巴西普治疗的 RA 患者进行了统计学分析。ATTRA 登记了 162 例接受阿巴西普治疗的 RA 患者,平均年龄 51.0±12.2(中位数 53.1,19-74 岁),疾病平均病程为 14±9.1,中位数 11.3 年(0-41 年)。130 例(80.2%)为女性。第 0 周时平均 DAS28 为 5.9±1.1,第 16 周时为 4.1±1.4,第 24 周时为 3.8±1.2,第 36 周时为 3.6±1.3,第 52 周时为 3.5±1.2。第 16 周时,15.8%的患者达到 DAS28 缓解,第 24 周时,10%的患者达到缓解,第 36 周时,20.9%的患者达到缓解,第 24 周时,20.8%的患者达到缓解。在第 16 周时 DAS28<2.6(缓解)的患者中,58.3%在第 52 周时仍处于缓解状态。在第 16 周时 DAS28>5.1(疾病活动度高)的患者中,只有 41.7%的患者在第 52 周时 DAS>5.1。治疗 1 年后的生存率为 82%。共有 36 例(22%)患者报告了 50 例非严重不良事件(AE),10 例(6%)患者报告了 11 例严重 AE,最常见的是感染(31 例)和皮疹(5 例)。仅报告了 1 例非严重过敏反应。ATTRA 登记处的数据证实了阿巴西普具有良好的总体疗效和安全性,且药物生存状况非常好。