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Safety and Tolerability of Omalizumab, A Randomized Clinical Trial of Humanized anti‐IgE Monoclonal Antibody in Systemic Lupus Erythematosus

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Qys秋 发表于 2019-1-4 09:00:07 | 显示全部楼层 |阅读模式
Safety and Tolerability of Omalizumab, A Randomized Clinical Trial of Humanized anti‐IgE Monoclonal Antibody in Systemic Lupus Erythematosus (STOP LUPUS)

Abstract

Background
Autoreactive IgE antibodies have been implicated in the pathogenesis systemic lupus erythematosus (SLE). We hypothesized that omalizumab, a monoclonal antibody (mAb) binding IgE, may improve SLE activity by reducing type I IFN production by hampering plasmacytoid dendritic cells and basophil activation. This study assessed the safety, tolerability, and clinical efficacy of omalizumab in mild to moderate SLE.

Methods
Fifteen subjects with SLE and a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) of > 4 and elevated autoreactive IgE antibodies were randomized to receive omalizumab or placebo (2:1) for 16 weeks, followed by 16‐week open label treatment and 4‐week washout period. SLEDAI 2K, British Isles Lupus Assessment Group index (BILAG 2004) and Physician Global Assessment (PGA) were recorded at each visit. Type I interferon (IFN) induced gene signature was determined using quantitative PCR.

Results
Omalizumab was well tolerated with no allergic reactions, and mostly mild adverse events comparable to placebo treatment. SLEDAI 2K scores improved in the omalizumab group at week 16 (p=0.038), as well as during the open label phase in subjects initially receiving placebo (p=0.020). No worsening in BILAG scores or PGA were detected. Omalizumab led to a trend towards reduction in IFN gene signature in subjects treated with omalizumab (p=0.11), especially in subjects with high baseline IFN signature (p=0.052).

Conclusion
Omalizumab is well tolerated in SLE and associated with improvement in disease activity. Larger randomized clinical trials will be needed to assess efficacy of omalizumab in patients with SLE.


奥马佐单抗的安全性和耐受性:抗-IgE人源化单克隆抗体治疗系统性红斑狼疮(阻止狼疮)的随机临床试验

摘要

背景
自身激活的IgE抗体与系统性红斑狼疮(SLE)的发病机制有关。我们假设奥马佐单抗,一种结合IgE的单克隆抗体(mAb),通过抑制浆细胞样树突状细胞和嗜碱性粒细胞的活化,减少I型干扰素的产生,可以提高SLE活性。本研究评估了奥马佐单抗治疗轻中度系统性红斑狼疮的安全性、耐受性和临床疗效。

方法
15名系统性红斑狼疮和系统性红斑狼疮疾病活动指数2000(SLEDAI 2K)大于4且自身活性IgE抗体升高的受试者随机接受奥马佐单抗或安慰剂(2:1)治疗16周,随后接受16周的开放标签治疗和4周的冲洗期。每次访问时记录狼疮活动指数(SlEDAI 2K)、不列颠群岛狼疮评估组指数(BILAG 2004)和医师全球评估(PGA)。采用定量聚合酶链反应(PCR)测定了I型干扰素(IFN)诱导的基因特征。

结果
奥马佐单抗耐受性良好,无过敏反应,主要是与安慰剂治疗相比的轻微不良事件。奥马利珠单抗组在第16周(p=0.038)以及在最初接受安慰剂的受试者中的开放标签阶段(p=0.020)的SlEDAI 2K评分有所改善。未检测到BILAG评分或PGA恶化。奥马佐单抗导使得受奥马佐单抗治疗的受试者(p=0.11)的IFN基因特征降低的趋势,尤其是在具有高基线IFN特征的受试者(p=0.052)中。

结论
奥马佐单抗在SLE中具有良好的耐受性,并与疾病活动的改善有关。需要更大的随机临床试验来评估奥马佐单抗对SLE患者的疗效。




英语翻译  邓秋梅 3151201020
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