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Arthritis Rheumatol:贝利单抗皮下给药:系统性红斑狼疮患者的福音?

2017-06-22 安雅晶 石岩 环球医学

贝利单抗静脉给药会加大患者的时间和财务投入,为了改善系统性红斑狼疮(SLE)患者的治疗体验,各国科学家展开对贝利单抗皮下(SC)给药方式的研究。2017年5月,发表在《Arthritis Rheumatol》的一项为期52周的随机、双盲、安慰剂组对照研究表明,贝利单抗SC给药治疗SLE有效且安全。目的:评估SLE患者中,贝利单抗SC给药的有效性和安全性。方法:中度至重度SLE患者[红斑狼疮国家评估

贝利单抗静脉给药会加大患者的时间和财务投入,为了改善系统性红斑狼疮(SLE)患者的治疗体验,各国科学家展开对贝利单抗皮下(SC)给药方式的研究。2017年5月,发表在《Arthritis Rheumatol》的一项为期52周的随机、双盲、安慰剂组对照研究表明,贝利单抗SC给药治疗SLE有效且安全。

目的:评估SLE患者中,贝利单抗SC给药的有效性和安全性。

方法:中度至重度SLE患者[红斑狼疮国家评估中雌激素安全性(SELENA)版本中SLE疾病活动指数(SLEDA)评分≥8]除进行标准SLE治疗52周外,按2:1随机分为每周用预充注射器贝利单抗SC给药200mg组或安慰剂组。首要终点是52周时SLE应答指数(SRI4)。次要终点是糖皮质激素剂量减少和到耀斑的时间。安全性依据报告的不良事件(AEs)和实验室检查结果进行评估。

结果:839名随机患者中,836名(贝利单抗组556名和安慰剂组280名)接受治疗。共有159名患者在研究结束前退出。开始时,贝利单抗组平均SELENA-SLEDAI评分是10.5,安慰剂组是10.3.。与接受安慰剂的患者相比,贝利单抗组中更多患者有SRI4应答[61.4% vs 48.4%;比值比(OR)1.68,95%置信区间(95%CI) 1.25~2.25);P=0.0006]。在40~52周期间,与安慰剂组相比,贝利单抗组中严重耀斑的时间和风险皆有改善(中位171.0天vs 118.0天;风险比0.51[95%CI 0.35~0.74];P=0.0004),更多患者能减少糖皮质激素剂量≥25%(达到≤7.5 mg/天)(18.2% vs 11.9%;OR 1.65[95% CI 0.95~2.84];P=0.0732)。治疗组之间的AE发病率相当;10.8%使用贝利单抗的患者和15.7%接受安慰剂的患者报告严重的AEs。0.9%使用贝利单抗的患者和1.4%接受安慰剂的患者发生≥2级的IgG低球蛋白血症恶化。

结论:中度至重度SLE患者中,每周贝利单抗SC给药剂量200mg+标准SLE治疗显着改善他们的SRI4应答,与安慰剂组相比能减少严重的疾病耀斑,并且安全性与安慰剂+标准SLE治疗相似。

原始出处:

Stohl W, Schwarting A, et al. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049.

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    2017-07-07 王晓霞

    学习

    0

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    2017-07-03 王晓霞

    希望有新的进展

    0

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    2017-06-24 zhaojie88
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    2017-06-24 zhouqu_8
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    2017-06-22 清风拂面

    非常好,希望有用

    0

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