Allergy Unit, Sant'Anna Hospital, Como, Italy.
Panminerva Med. 2012 Dec;54(4):305-12.
The immunoglobulin E (IgE) are a key factor in the pathophysiology of allergic diseases and the important therapeutic role of an anti-IgE antibody was long envisioned. It took time and efforts to solve the safety problems related to the anaphylactogen capacity of anti-IgE, finally crowned by the introduction of the humanized, monoclonal anti-IgE antibody omalizumab. Currently, omalizumab is indicated, based on clear evidence of efficacy, only in severe allergic asthma not controlled by conventional treatment. However, a continuously increasing amount of literature shows that omalizumab is efficacious in a number of disorders concerning the upper and lower airway and the skin, and, most importantly, in anaphylaxis. The latter application was demonstrated successful in placebo-controlled trials and warrants for a new, life-saving, indication for omalizumab. Also, the systemic reactions precluding the performance of allergen immunotherapy, especially concerning Hymenoptera venom, were prevented by omalizumab treatment. The most surprising success of omalizumab regards clinical conditions thus far considered unrelated to IgE antibodies. This is true for intrinsic asthma and for idiopathic urticaria (demonstrated by a placebo-controlled trial), and angioedema, suggesting in these condition a pathophysiologic role of IgE. These observations support a off-label use of omalizumab in patients suffering from IgE-related pathologies other than asthma who are at risk of fatal events or are uncontrolled by the optimal standard treatment.
免疫球蛋白 E（IgE）是过敏疾病病理生理学的关键因素，抗 IgE 抗体的重要治疗作用早已被设想。解决抗 IgE 的过敏原能力相关的安全性问题需要时间和努力，最终推出了人源化、单克隆抗 IgE 抗体奥马珠单抗。目前，奥马珠单抗基于疗效的明确证据，仅被批准用于常规治疗无法控制的严重过敏性哮喘。然而，越来越多的文献表明，奥马珠单抗在涉及上呼吸道和下呼吸道以及皮肤的多种疾病中具有疗效，最重要的是在过敏反应中具有疗效。后者的应用在安慰剂对照试验中得到了证实，为奥马珠单抗开辟了一个新的、拯救生命的适应证。此外，奥马珠单抗治疗还可以预防全身性反应，从而排除过敏原免疫治疗的进行，特别是针对蜂毒液。奥马珠单抗最令人惊讶的成功之处在于针对迄今为止被认为与 IgE 抗体无关的临床病症。这在特发性哮喘和特发性荨麻疹（一项安慰剂对照试验证明）和血管性水肿中是如此，表明在这些情况下 IgE 具有病理生理学作用。这些观察结果支持在 IgE 相关病理学患者中使用奥马珠单抗，这些患者存在致命事件的风险或对最佳标准治疗无法控制。
