Department of Pediatrics, University of North Texas, Fort Worth, TX 76132, USA.
J Allergy Clin Immunol. 2009 Dec;124(6):1210-6. doi: 10.1016/j.jaci.2009.09.021.
Many children with asthma continue to experience symptoms despite available therapies.
This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications.
A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase).
A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo.
Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.
尽管有多种治疗方法，但许多哮喘儿童仍存在症状。
本研究评估奥马珠单抗（一种人源化抗 IgE mAb）在中高剂量吸入皮质激素（ICS）联合或不联合其他控制药物治疗但仍未得到充分控制的中重度持续性过敏性（IgE 介导）哮喘儿童中的疗效和安全性。
一项随机、双盲、安慰剂对照试验纳入了年龄为 6 至<12 岁、有常年过敏原敏感性和既往因哮喘加重和症状而就诊史的患儿，这些患儿即使使用了中高剂量 ICS 也未得到充分控制。患者以 2:1 的比例随机接受奥马珠单抗（皮下注射 75-375mg，每 2 或 4 周 1 次）或安慰剂治疗，为期 52 周（24 周固定剂量 ICS 期后为 28 周可调剂量 ICS 期）。
共有 627 名患者（奥马珠单抗，n=421；安慰剂，n=206）被随机分组，576 名（奥马珠单抗，n=384；安慰剂，n=192）患者进行了疗效分析。在 24 周固定剂量 ICS 期内，奥马珠单抗使临床显著哮喘加重（症状恶化，需要加倍基础 ICS 剂量和/或全身用皮质激素）的发生率降低了 31%（0.45 比 0.64；率比，0.69；P=0.007）。在 52 周期间，与安慰剂相比，哮喘加重率降低了 43%（P<0.001）。奥马珠单抗显著降低严重哮喘加重的发生率。在 52 周期间，奥马珠单抗具有可接受的安全性，与安慰剂相比，不良事件总发生率无差异。
在中重度持续性过敏性（IgE 介导）哮喘患儿（6 至<12 岁）中，奥马珠单抗作为维持治疗有效且耐受良好，这些患儿即使使用中高剂量 ICS 也无法充分控制症状。
