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首页> 外文期刊>Expert opinion on biological therapy >Mavrilimumab, a human monoclonal GM-CSF receptor-α antibody for the management of rheumatoid arthritis: a novel approach to therapy.
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Mavrilimumab, a human monoclonal GM-CSF receptor-α antibody for the management of rheumatoid arthritis: a novel approach to therapy.

机译：Mavrilimumab，一种用于治疗类风湿关节炎的人类单克隆GM-CSF受体-α抗体：一种新颖的治疗方法。

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INTRODUCTION: Mavrilimumab , formerly known as CAM-3001, a GM-CSF receptor-α antibody, is the first human monoclonal antibody to be used in Phase II studies (2011) to modulate the innate immunity pathway targeting GM-CSF signaling in moderate rheumatoid arthritis (RA). AREAS COVERED: Analysis of available clinical trial data on GM-CSF receptor-α antibody and medical literature search using MEDLINE for molecular mechanisms of pathogenesis of RA and its treatment forms the basis of this expert opinion review. The mavrilimumab Phase II double blind, randomized, placebo-controlled ascending dose trial demonstrated statistically significant achievement of primary and secondary end points in patients with moderate RA. The trial demonstrated significant clinical benefit in the 100 mg mavrilimumab cohort compared to the placebo group. EXPERT OPINION: The novel molecular targeting mechanism of mavrilimumab together with its demonstrated clinical efficacy, tolerability and safety profile in Phase II clinical trials in moderate RA, suggests significant potential utility for this drug to induce clinical remission, reduce flares and improve morbidity and mortality in patients with RA.
机译：简介：Mavrilimumab（前身为CAM-3001，一种GM-CSF受体-α抗体），是第一批用于II期研究（2011年）的药物，可调节中度类风湿中针对GM-CSF信号传导的先天免疫途径关节炎（RA）。覆盖的领域：GM-CSF受体-α抗体的可用临床试验数据分析以及使用MEDLINE进行RA发病机理及其治疗的分子生物学方法的医学文献检索，构成了本专家意见审查的基础。 mavrilimumab II期双盲，随机，安慰剂对照的递增剂量试验显示，中度RA患者的主要和次要终点在统计学上具有显着意义。与安慰剂组相比，该试验在100 mg mavrilimumab队列中显示出显着的临床益处。专家意见：mavrilimumab的新型分子靶向机制及其在中度RA的II期临床试验中证明的临床疗效，耐受性和安全性表明，该药物在诱导临床缓解，减少耀斑，改善发病率和死亡率方面具有巨大的潜在用途。 RA患者。

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