对于ANCA相关性血管炎病人,联合使用环磷酰胺和糖皮质激素可缓解绝大部分病人的病情,但复发率高。在新发和复发病人中使用利妥昔单抗,与硫唑嘌呤比,可使更多的ANCA-相关血管炎病人在28个月后病情仍然缓解,严重副反应事件发生率无差别。

20141106日《新英格兰医学杂志》

 

中文译文


 

【题目】在ANCA-相关性血管炎维持治疗中使用利妥昔单抗与硫唑嘌呤的比较

【译文】

背景:对于抗中性粒细胞胞浆抗体(ANCA)相关血管炎,联合使用环磷酰胺和糖皮质激素可缓解绝大部分病人的病情。但是,即使是接受硫唑嘌呤或甲氨蝶呤进行维持治疗的病人,复发率仍然居高不下。利妥昔单抗可能有助于持续缓解病情。

方法:新诊断的肉芽肿血管炎、显微镜下多血管炎或肾脏局限性ANCA相关性血管炎病人,或经环磷酰胺和糖皮质激素治疗完全缓解后又复发的病人,随机分配到两组:在进入研究后第61218个月的014天接受500mg 利妥昔单抗治疗,或者每天使用硫唑嘌呤直至22个月。主要终点是28个月的主要缓解率(再次出现病情活跃或加重并且伯明翰系统性血管炎活动评分>0,至少1个主要器官受累,出现疾病相关的致命事件,或各情况均出现)。

结果:共招募了115个病人,(87例肉芽肿血管炎,23例显微镜下多血管炎,5例肾脏局限性ANCA相关性血管炎)接受硫唑嘌呤(58例)或利妥昔单抗(57例)治疗。在第28个月,硫唑嘌呤组有17例(29%)复发,利妥昔单抗组3例(5%)复发(复发危险比:6.6195%CI1.56-27.96P=0.002)。两组发生严重副反应事件的频率相似。两组各有25例发生严重副反应事件(P=0.92);硫唑嘌呤组发生44次,利妥昔单抗组发生45次。硫唑嘌呤组有8例,利妥昔单抗组有11例发生严重感染;硫唑嘌呤组有2例,利妥昔单抗组有1例发生癌症。硫唑嘌呤组出现2例死亡(1例死于败血症,1例死于胰腺癌)。

 

结论:与硫唑嘌呤相比,利妥昔单抗可使更多的ANCA-相关血管炎病人在28个月后病情仍然缓解。

 

英文原稿


 

[Title] Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis.

[Authors] Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, et al.

[Abstract]

BACKGROUND: The combination of cyclophosphamide and glucocorticoids leads to remission in most
patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitides. However, even when
patients receive maintenance treatment with azathioprine or methotrexate, the relapse rate remains high.
Rituximab may help to maintain remission.

METHODS: Patients with newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or renal-limited ANCA-associated vasculitis in complete remission after a cyclophosphamide-glucocorticoid regimen were randomly assigned to receive either 500 mg of rituximab on days 0 and 14 and at months 6, 12, and 18 after study entry or daily azathioprine until month 22. The primary end point at month 28 was the rate of major relapse (the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score >0, and involvement of one or more major organs, disease-related life-threatening events, or both).

RESULTS: The 115 enrolled patients (87 with granulomatosis with polyangiitis, 23 with microscopic polyangiitis, and 5 with renal-limited ANCA-associated vasculitis) received azathioprine (58 patients) or rituximab (57 patients). At month 28, major relapse had occurred in 17 patients in the azathioprine group (29%) and in 3 patients in the rituximab group (5%) (hazard ratiofor relapse, 6.61; 95% confidence interval, 1.56 to 27.96; P=0.002). The frequencies of severe adverse events were similar in the two groups. Twenty-five patients in each group (P=0.92) had severe adverse events; there were 44 events in the azathioprine group and 45 in the rituximab group. Eight patients in the azathioprine group and 11 in the rituximab group had severe infections, and cancer developed in 2 patients in the azathioprine group and 1 in the rituximab group. Two patients in the azathioprine group died (1 from sepsis and 1 from pancreatic cancer).

CONCLUSIONS: More patients with ANCA-associated vasculitides had sustained remission at month 28 with rituximab than with azathioprine.

 

原文网址

http://www.nejm.org/doi/full/10.1056/NEJMoa1404231

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