Department of Rheumatology, Kameda Medical Center, 929 Higashi-Cho, Kamogawa City, Chiba Prefecture 296-8602, Japan.
Rheumatology (Oxford). 2011 Nov;50(11):2093-9. doi: 10.1093/rheumatology/ker295. Epub 2011 Sep 2.
To assess the effectiveness, drug survival and safety of tocilizumab compared with TNF-α inhibitors in clinical practice.
Patients in the Cohort of Arthritis Biologic Users at Kameda Institute (CABUKI) registry who were on biologics during July 2003 to October 2010 were included. Remission rates at 6 months, Kaplan-Meier drug survival estimates and serious adverse event (SAE) rates were compared.
A total of 247 RA patients were analysed. For first-line biologic users, the 6-month 28-joint DAS (DAS-28)-ESR remission rates were 66.7% for tocilizumab vs 25.8% for TNF inhibitors (P < 0.001, Fisher's exact test). This advantage disappeared with the application of the newly suggested Boolean remission criterion for clinical trials: 0% for tocilizumab vs 8.2% for TNF inhibitors (P = 0.367, Fisher's exact test). Tocilizumab users in DAS-28-ESR remission had lower mean ESR (3.9 mm/h for tocilizumab vs 7.9 mm/h for TNF inhibitors, P = 0.026, t-test) and higher mean swollen joint count (2.6 for tocilizumab vs 1.3 for TNF inhibitors, P = 0.036, t-test), thus failing to meet the more stringent Boolean criteria. First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.
Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry. Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission. However, the newly suggested Boolean criteria are more appropriate measures of effectiveness as DAS-28-ESR remission by tocilizumab was mainly due to very low ESR in our study population.
评估托珠单抗与 TNF-α 抑制剂在临床实践中的疗效、药物生存率和安全性。
本研究纳入了 2003 年 7 月至 2010 年 10 月期间在加美达研究所关节炎生物制剂使用者队列（CABUKI）登记处使用生物制剂的患者。比较了 6 个月时的缓解率、Kaplan-Meier 药物生存率估计值和严重不良事件（SAE）发生率。
共分析了 247 例 RA 患者。对于一线生物制剂使用者，托珠单抗的 6 个月 28 关节 DAS（DAS-28-ESR）缓解率为 66.7%，而 TNF 抑制剂为 25.8%（P<0.001，Fisher 确切检验）。然而，当应用新提出的临床试验布尔缓解标准时，这种优势消失了：托珠单抗为 0%，而 TNF 抑制剂为 8.2%（P=0.367，Fisher 确切检验）。在 DAS-28-ESR 缓解的托珠单抗使用者中，ESR 均值较低（托珠单抗为 3.9mm/h，TNF 抑制剂为 7.9mm/h，P=0.026，t 检验），且肿胀关节计数均值较高（托珠单抗为 2.6，TNF 抑制剂为 1.3，P=0.036，t 检验），因此未能达到更严格的布尔标准。一线和二线托珠单抗使用者与 TNF 抑制剂使用者的药物生存率和 SAE 发生率相似。
在这项日本单中心登记研究中，托珠单抗的药物生存和安全性与 TNF 抑制剂相似。与 TNF 抑制剂相比，托珠单抗在 6 个月时通过 DAS-28-ESR 缓解具有优势。然而，新提出的布尔标准更适合作为疗效的衡量标准，因为在我们的研究人群中，托珠单抗的 DAS-28-ESR 缓解主要归因于非常低的 ESR。
Zotero 插件
