Rituximab for induction and maintenance therapy in granulomatosis with polyangiitis (Wegener's). Results of a single-center cohort study on 66 patients
Rituximab for induction and maintenance therapy in granulomatosis with polyangiitis (Wegener's). Results of a single-center cohort study on 66 patients
复制标题
DOI：
10.1016/j.jaut.2014.03.002
复制
发表时间：
2014-05-01
影响因子：
12.8
通讯作者：
Guillevin, Loic
中科院分区：
文献类型：
--
作者：
Calich, Ana Luisa;Puechal, Xavier;Guillevin, Loic
本研究的目的是根据疾病的严重程度，评估利妥昔单抗（RTX）与糖皮质激素联合治疗的疗效和安全性，作为肉芽肿伴多血管炎（GPA）的缓解诱导治疗（Wegener's），并分析在常规的基于时间的方案中使用低剂量RTX的长期维持治疗的结果。中心回顾性研究使用了2002年至2013年期间接受RTX的所有CPA患者的标准化数据收集。缓解诱导方案由RTX和糖皮质激素组成，根据疾病严重程度进行调整。一旦达到缓解，患者接受RTX维持治疗（每6个月500 mg）18个月。6个月后，这些患者中有78.8%的患者通过中度口服泼尼松方案（基线平均剂量为32.8 +/- 23.4 mg/天）获得了缓解。声门下狭窄增加了治疗失败的风险（OR = 312，P = 0.0104）。92%的CPA患者继续RTX维持治疗18个月，随访34.2 +/- 26.2个月（平均总累积RTX剂量为4.6 +/- 1.7 g）。复发率为11.2/100患者年。复发发生在最后一次“RTX输注”后平均13.5 +/- 14.7个月。记录了21例严重不良事件; 13.6%的患者发生了严重infection.We的结论是，在这个单中心队列中，RTX与糖皮质激素治疗相适应的疾病严重程度似乎可以有效地诱导CPA患者的缓解。在常规的基于时间的方案中使用低剂量RTX的维持治疗是安全的，并且与治疗后的低复发率相关。(c)2014爱思唯尔有限公司版权所有。
The aim of this study was to evaluate the efficacy and safety of rituximab (RTX) associated with glucocorticoid treatment based on disease severity, as a remission induction treatment for granulomatosis with polyangiitis (GPA) (Wegener's) and to analyze the results of long-term maintenance therapy with low doses of RTX in a routine time-based protocol.This single-center retrospective study used standardized data collection from all CPA patients receiving RTX between 2002 and 2013. The remission induction regimen consisted of RTX and gluco-corticoids, adapted according to disease severity. Once remission was achieved, patients received RTX maintenance treatment (500 mg every 6 months) for 18 months.Sixty-six CPA patients received RTX for remission induction. After six months, a response had been achieved in 78.8% of these patients, with a moderate oral prednisone regimen (mean dose at baseline, 32.8 +/- 23.4 mg/day). Subglottic stenosis increased the risk of treatment failure (OR = 312, P = 0.0104). RTX maintenance treatment was continued for 18 months in 92% of the CPA patients, who were followed for 34.2 +/- 26.2 months (mean total cumulative RTX dose of 4.6 +/- 1.7 g). The relapse rate was 11.2/100 patient-years. The relapses occur a mean of 13.5 +/- 14.7 months after the last "RTX infusion. Twenty-one severe adverse events were recorded; 13.6% patients had severe infections.We conclude that in this single-center cohort, RTX associated with glucocorticoid treatment adapted for disease severity appeared to induce remission effectively in CPA patients. Maintenance treatment with low doses of RTX in a routine time-based protocol was safe and associated with low rates of relapse on treatment. (c) 2014 Elsevier Ltd. All rights reserved.