Sarilumab +甲氨蝶呤活跃类风湿性关节炎患者的甲氨蝶呤和反应不足:一项III期研究的结果。

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热那亚的MC,她R, Kivitz AJ, Rell-Bakalarska M, Martincova R,百花大教堂,Rohane P,凡根H,加戈,风扇C, van Adelsberg J,温斯坦SP,斯塔尔N,格雷厄姆•纳米Yancopoulos GD,惠钦格TW, van der Heijde D

Sarilumab +甲氨蝶呤活跃类风湿性关节炎患者的甲氨蝶呤和反应不足:一项III期研究的结果。

关节炎Rheumatol。2015年6月,67 (6):1424 - 37。doi: 10.1002 / art.39093。

PubMed ID

25733246 (在PubMed

]

文摘

摘要目的:评价的有效性和安全性sarilumab结合甲氨蝶呤(MTX)治疗类风湿性关节炎(RA)。方法:成人严重RA和不适当的应对MTX随机(比)接收sarilumab(剂量150毫克或200毫克)或安慰剂每2周在每周与MTX 52周。Co-primary端点是患者实现美国风湿病学院20%的比例(ACR20)改进反应在24周,从基线健康评估问卷(HAQ)残疾指数(DI)在第16周,和基线的变化修改锋利/ van der Heijde得分(合成)的射线伤害在52周。结果:基线特征相似的组。对于所有3 co-primary端点,sarilumab 150毫克和200毫克组表明显著改善与安慰剂组相比(ACR20反应率在24周,58.0%,66.4%,和33.4%,分别为(P < 0.0001);最小二乘均值变化哈克DI在第16周,-0.53,-0.55,和-0.29,分别(P < 0.0001);意味着改变啦在52周,0.90,0.25,和2.78,分别(P < 0.0001)。最常见的治疗诱发的副反应是感染。sarilumab 150毫克,sarilumab 200毫克,和安慰剂组,严重感染的发生率为2.6%,4.0%,和2.3%,分别。海拔>丙氨酸转氨酶水平三倍的上限一般发生在9.5%,8.0%,和2.1%的病人,分别; in 24 patients, this led to discontinuation of treatment. Elevated total cholesterol levels were observed in 36.8%, 43.0%, and 18.3% of patients, respectively. In patients receiving 150 mg and 200 mg sarilumab, neutrophil counts of 0.5 to <1.0 x 10(9) /liter were observed in 5.1% and 7.8% of patients, respectively, while neutrophil counts of <0.5 x 10(9) /liter were observed in 0.9% and 0.7% of patients, respectively; none of the patients receiving placebo experienced changes in neutrophil counts. CONCLUSION: In RA patients treated with sarilumab (150 mg or 200 mg every 2 weeks) in combination with MTX, both doses provided sustained clinical efficacy, as shown by significant improvements in symptomatic, functional, and radiographic outcomes. Sarilumab was generally well tolerated. The adverse events observed in this study were consistent with the effects of interleukin-6 signaling blockade.

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药物

Sarilumab