利妥昔单抗在难治性狼疮中标签外使用的疗效和安全性：来自意大利多中心注册研究的数据。

Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry.

作者信息

Iaccarino Luca, Bartoloni Elena, Carli Linda, Ceccarelli Fulvia, Conti Fabrizio, De Vita Salvatore, Ferraccioli Gianfranco, Galeazzi Mauro, Gatto Mariele, Gerli Roberto, Govoni Marcello, Gremese Elisa, Iuliano Annamaria, Mansutti Elena, Moroni Gabriella, Mosca Marta, Nalli Cecilia, Naretto Carla, Padovan Melissa, Palma Lavinia, Raffiotta Francesca, Roccatello Dario, Tincani Angela, Valesini Guido, Zen Margherita, Doria Andrea

机构信息

Department of Medicine-DIMED, Division of Rheumatology, University of Padova, Italy.

Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy.

出版信息

Clin Exp Rheumatol. 2015 Jul-Aug;33(4):449-56. Epub 2015 Jun 8.

PMID:26053285

Abstract

OBJECTIVES

To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting.

METHODS

145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1< ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis.

RESULTS

Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred.

CONCLUSIONS

Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

摘要

目的

在临床实践环境中评估利妥昔单抗（RTX）治疗对标准治疗无效的系统性红斑狼疮（SLE）患者的疗效和安全性。

方法

145例符合美国风湿病学会（ACR）标准的SLE患者在意大利的11个中心接受RTX治疗：118例接受两次输注（每次1 g），间隔两周；27例接受4次输注（375 mg/m²），间隔一周，其中10例在1个月和2个月后再接受两次剂量输注。全身完全缓解（CR）定义为欧洲狼疮活动度共识测量（ECLAM）评分≤1，部分缓解（PR）定义为1＜ECLAM≤3。肾脏CR（RCR）和肾脏PR（RPR）根据欧洲抗风湿病联盟（EULAR）关于狼疮性肾炎管理的建议进行定义。

结果

获得了134例（92.4%）患者的数据。平均随访时间为27.3±18.5个月。在首次RTX疗程后，85.8%的患者观察到CR或PR，45.5%的患者观察到CR；随访12个月后，94.1%的患者观察到RCR或RPR，30.9%的患者观察到RCR。在观察期内，35.1%的患者出现疾病复发，31.2%的患者出现肾脏复发。在接受再次治疗的患者中，84.4%的患者观察到CR或PR，57.8%的患者观察到CR。首次RTX疗程后，23.8%的患者发生不良事件，16.4%的患者发生感染，3.8%的患者发生输注反应；再次治疗后，分别有33.3%、22.2%和11.1%的患者发生上述情况。未发生严重输注反应或死亡。