Effect of omalizumab on symptoms of seasonal allergic rhinitis - A randomized controlled trial
Effect of omalizumab on symptoms of seasonal allergic rhinitis - A randomized controlled trial
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DOI：
10.1001/jama.286.23.2956
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发表时间：
2001-12-19
影响因子：
120.7
通讯作者：
Della Cioppa, G
中科院分区：
文献类型：
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作者：
Casale, TB;Condemi, J;Della Cioppa, G
季节性变应性鼻炎是一种常见的IgE介导的疾病，会产生麻烦的症状，一种重组人源化单克隆抗IgE抗体（omalizumab）与游离IgE形成复合物，阻断其与肥大细胞和嗜碱性粒细胞的相互作用，降低循环中的游离IgE水平。目的评价奥玛珠单抗预防季节性变应性鼻炎患者症状的有效性和安全性。设计1997年7月25日至11月21日进行的随机、双盲、剂量范围、安慰剂对照试验。在美国设立了25个门诊中心。536例患者，年龄12 - 75岁，至少有2年中度至重度豚草引起的季节性变应性鼻炎病史，基线IgE水平在30 - 700 IU/mL之间。干预措施患者被随机分配接受omalizumab， 50 mg (n=137), 150 mg (n=134)，或300 mg (n=129)，或安慰剂（n=136），在豚草季节之前皮下注射，并在花粉季节每3周重复一次基线IgE水平为151至700 IU/mL（4次总治疗）的患者，每4周重复一次基线IgE水平为30至150 IU/mL（3次总治疗）的患者。自治疗开始12周内，每日自评鼻部症状严重程度评分（范围0-3）、抗组胺药物的抢救使用和鼻炎特异性生活质量。结果300mg omalizumab组鼻症状严重程度评分明显低于安慰剂组（最小二乘均值，分别为0.75 vs 0.98； P= 0.002）。观察到IgE降低与鼻症状和抢救抗组胺药使用之间存在显著关联。接受300mg omalizumab治疗的患者的鼻炎特异性生活质量评分始终优于接受低剂量或安慰剂治疗的患者，并且在高峰季节没有下降。不良事件发生的频率在奥玛珠单抗组和安慰剂组之间没有显著差异。结论Omalizumab降低了季节性变应性鼻炎患者血清游离IgE水平，并以剂量依赖性的方式提供临床获益。
Context Seasonal allergic rhinitis is a common IgE-mediated disorder that produces troublesome symptoms, A recombinant humanized monoclonal anti-IgE antibody (omalizumab) forms complexes with free IgE, blocking its interaction with mast cells and basophils and lowering free IgE levels in the circulation.Objective To assess the efficacy and safety of omalizumab for prophylaxis of symptoms in patients with seasonal allergic rhinitis.Design Randomized, double-blind, dose-ranging, placebo-controlled trial conducted from July 25 through November 21, 1997.Setting Twenty-five outpatient centers throughout the United States.Patients Five hundred thirty-six patients aged 12 to 75 years with at least a 2-year history of moderate to severe ragweed-induced seasonal allergic rhinitis and a baseline IgE level between 30 and 700 IU/mL.Interventions Patients were randomly assigned to receive omalizumab, 50 mg (n=137), 150 mg (n=134), or 300 mg (n=129), or placebo (n=136) subcutaneously just prior to ragweed season and repeated during the pollen season every 3 weeks in patients with baseline IgE levels of 151 to 700 IU/mL (4 total treatments) and every 4 weeks in patients with baseline IgE levels of 30 to 150 IU/mL (3 total treatments).Main Outcome Measures Self-assessed daily nasal symptom severity scores (range, 0-3), rescue antihistamine use, and rhinitis-specific quality of life during the 12 weeks from the start of treatment.Results Nasal symptom severity scores were significantly lower in patients who received 300 mg of omalizumab than in those who received placebo (least squares means, 0.75 vs 0.98, respectively; P=.002). A significant association was observed between IgE reduction and nasal symptoms and rescue antihistamine use. Rhinitis-specific quality of life scores were consistently better in patients who received 300 mg of omalizumab than in those who received lower dosages or placebo and did not decline during peak season. The frequency of adverse events was not significantly different among the omalizumab and placebo groups.Conclusion Omalizumab decreased serum free IgE levels and provided clinical benefit in a dose-dependent fashion in patients with seasonal allergic rhinitis.