Safety and tolerability of omalizumab
Safety and tolerability of omalizumab
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DOI：
10.1111/j.1365-2222.2009.03214.x
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发表时间：
2009-06-01
影响因子：
6.1
通讯作者：
Jimenez, P.
中科院分区：
文献类型：
--
作者：
Corren, J.;Casale, T. B.;Jimenez, P.
Omalizumab（Xolair（（R））是一种重组人源化单克隆抗IgE抗体，已证实对中重度和重度持续性过敏性鼻炎患者有效。（IgE介导的）哮喘：回顾临床研究数据以评估奥马珠单抗的安全性。我们使用已完成的临床研究数据分析奥马珠单抗的安全性（长达1年），涉及超过7500例哮喘、鼻炎或相关疾病患者，在一项重度过敏性哮喘患者研究中长达4年，以及上市后安全性数据。分析的重点是免疫系统效应、超敏反应、恶性肿瘤、寄生虫感染和血小板减少症的风险。奥马珠单抗在一项研究中显示出良好的安全性和耐受性，并可维持长达4年。奥马珠单抗治疗患者和对照患者的过敏反应发生率分别为0.14%和0.07%。奥马珠单抗治疗患者均未出现可测量的抗奥马珠单抗抗体。上市后，基于57300例患者的估计暴露量（2003年6月至2006年12月），估计奥马珠单抗使用导致的速发型过敏反应发生率至少为0.2%。目前的临床试验数据不支持omalizumab增加恶性肿瘤或血小板减少症的风险，数据表明，在中度至重度或重度过敏性哮喘患者中添加omalizumab的有效性已得到证实，并伴有良好的安全性和耐受性。
Omalizumab (Xolair((R))) is a recombinant humanized monoclonal anti-IgE antibody with proven efficacy in patients with moderate-to-severe and severe persistent allergic (IgE-mediated) asthma.To review clinical study data to assess the safety profile of omalizumab.We analysed the safety of omalizumab using data from completed clinical studies (up to 1 year) involving more than 7500 patients with asthma, rhinitis or related conditions and up to 4 years in one study of patients with severe allergic asthma, as well as post-marketing safety data. Analysis focuses on the risk of immune-system effects, hypersensitivity reactions, malignant neoplasia, parasitic infections and thrombocytopenia.Omalizumab exhibited a good safety and tolerability profile that was maintained up to 4 years in one study. The incidence of anaphylaxis was 0.14% in omalizumab-treated patients and 0.07% in control patients. No omalizumab-treated patient developed measurable anti-omalizumab antibodies. Post-marketing, based on estimated exposure of 57 300 patients (June 2003-December 2006), the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients. Current clinical trial data do not support an increased risk of malignant neoplasia or thrombocytopenia with omalizumab.Data indicate that the proven efficacy of add-on omalizumab in patients with moderate-to-severe or severe allergic asthma is accompanied by a favourable safety and tolerability profile.