OBJECTIVE:Omalizumab (Xolair), is a recombinant humanised monoclonal anti-immunoglobulin E (IgE) antibody, for the treatment of allergic asthma. This review describes how the correlation between clinical outcomes and a suitable surrogate marker (free serum IgE) led to the development of an individualised dosing strategy for omalizumab. It also demonstrates how subsequent studies using this dosing strategy were able to achieve low levels of IgE and clinical benefit. DATA SOURCES:Published articles and data on file (Novartis Pharma AG, Genentech). RESULTS:Studies in patients with IgE-mediated diseases of the airways have shown that clinical benefit with omalizumab is observed when free IgE levels in serum are reduced to 50 ng/ml (20.8 IU/ml) or less (target 25 ng/ml (10.4 IU/ml)). The ability of omalizumab to reduce free IgE levels to such levels is dependent on dose, the patient's weight and baseline IgE level. To simplify dosing, and ensure that free IgE reduction is achieved, an individualised tiered dosing table was developed from which patients with asthma, depending on weight and starting IgE level, receive omalizumab 150-375 mg by subcutaneous injection every 2 or 4 weeks. This dosing strategy has proved clinically efficacious for improving disease control in patients with allergic asthma, as shown by significantly lower exacerbation rates and decreased dependence on treatment with inhaled corticosteroids, along with improvements in symptoms, lung function and usage of rescue bronchodilators. CONCLUSIONS:The clinical efficacy of omalizumab has been optimised through the development of an individualised dosing table that emerged from an understanding of the pharmacodynamics of this agent.

译文

目的:奥马珠单抗(Xolair)是一种重组人源化单克隆抗免疫球蛋白E(IgE)抗体,用于治疗过敏性哮喘。这篇综述描述了临床结果与合适的替代指标(游离血清IgE)之间的相关性如何导致奥马珠单抗的个体化给药策略的发展。它还证明了使用该剂量策略的后续研究如何能够实现低水平的IgE和临床益处。
数据来源:已发表的文章和数据存档(Novartis Pharma AG,Genentech)。
结果:对IgE介导的气道疾病患者的研究表明,当血清中的游离IgE水平降低至50 ng / ml(20.8 IU / ml)或更低(目标为25 ng / ml( 10.4 IU / ml)。奥马珠单抗将游离IgE水平降低至该水平的能力取决于剂量,患者体重和基线IgE水平。为了简化剂量,并确保实现免费的IgE降低,开发了个性化的分层剂量表,根据体重和起始IgE水平,哮喘患者每2或4周通过皮下注射接受奥马珠单抗150-375 mg。这种给药策略已被证明在临床上有效地改善了过敏性哮喘患者的疾病控制,这表现为明显降低了急性发作率,降低了对吸入性糖皮质激素治疗的依赖性,并改善了症状,改善了肺功能并使用了急救性支气管扩张剂。
结论:奥马珠单抗的临床疗效已通过开发个性化剂量表而得以优化,该剂量表是从对该药的药效学理解中得出的。

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