Department of Pediatrics, University of Pavia, Fondazione IRCCS San Matteo, Pavia, Italy.
Paediatr Drugs. 2014 Dec;16(6):491-502. doi: 10.1007/s40272-014-0107-z.
Omalizumab is a recombinant humanized monoclonal antibody that reduces levels of circulating immunoglobulin E (IgE) and expression of IgE high-affinity receptors on mast cells and basophils, interrupting the subsequent allergic inflammatory cascade. Current indications for treatment with omalizumab in pediatric patients are clearly defined and are confined to moderate-to-severe uncontrolled allergic asthma and chronic spontaneous urticaria (CSU). Any other prescription can only be off label. Data available from clinical trials conducted in children suggest that omalizumab is clinically effective and generally well tolerated. Given its mechanism of action, recent reports have suggested its possible clinical use in other IgE-mediated disorders, such as allergic rhinitis, food allergy, and anaphylaxis. In recent years, several studies have also investigated the possible applications of omalizumab in a number of non IgE-mediated diseases. The aim of the present review is to assess all applications of omalizumab as therapy in the pediatric population. The approved indications--allergic asthma and CSU--are reviewed. Moreover, further potential applications of omalizumab are discussed in both IgE-mediated and non-IgE-mediated diseases.
奥马珠单抗是一种重组人源化单克隆抗体,可降低循环免疫球蛋白 E(IgE)水平,并抑制肥大细胞和嗜碱性粒细胞上 IgE 高亲和力受体的表达,从而阻断随后的过敏炎症级联反应。目前奥马珠单抗在儿科患者中的治疗适应证明确,仅限于中重度未控制的过敏性哮喘和慢性自发性荨麻疹(CSU)。任何其他适应证均为超适应证用药。来自儿童临床试验的数据表明,奥马珠单抗具有临床疗效,且通常具有良好的耐受性。鉴于其作用机制,最近的报告提示其在其他 IgE 介导的疾病(如过敏性鼻炎、食物过敏和过敏反应)中的可能临床应用。近年来,多项研究还探讨了奥马珠单抗在多种非 IgE 介导疾病中的潜在应用。本综述旨在评估奥马珠单抗在儿科人群中的所有治疗应用。我们对已批准的适应证(过敏性哮喘和 CSU)进行了综述。此外,还讨论了奥马珠单抗在 IgE 介导和非 IgE 介导疾病中的进一步潜在应用。