Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma
Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma
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DOI：
10.1067/mai.2001.117880
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发表时间：
2001-08-01
影响因子：
14.2
通讯作者：
Gupta, N
中科院分区：
文献类型：
--
作者：
Busse, W;Corren, J;Gupta, N
背景：重组人源化抗IgE单抗omalizumab与游离的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，从而可能有效地治疗哮喘。本研究的目的是评价奥马珠单抗治疗吸入性糖皮质激素依赖型哮喘的疗效和安全性。方法：在这项III期双盲安慰剂对照试验中，525名需要每日吸入皮质类固醇的严重过敏性哮喘患者被随机分成两组，每隔2周或4周皮下注射安慰剂或奥马珠单抗，具体取决于基线的IgE水平和体重。吸入皮质类固醇剂量。结果：与安慰剂组相比，奥马珠单抗治疗的受试者在激素稳定阶段(分别为0.28比0.54[P=.006]和减退阶段(分别为0.39比0.66[P=.003]和21.3%比32.3%[P=.004])哮喘发作显著减少(分别为0.28比0.54[P=.006]和14.6%比23.3%[P=.009])。奥马珠单抗治疗组的二丙酸倍氯米松降幅明显大于安慰剂组(中位数75%比50%[P
Background: A recombinant humanized anti-IgE mAb, omalizumab, forms complexes with free IgE, blocking its interaction with mast cells and basophils; as a consequence, it might be effective in the treatment of asthma.Objective. The purpose of this study was to evaluate the efficacy and safety of omalizumab in the treatment of inhaled corticosteroid-dependent asthma. Methods: In this phase III, double-blinded, placebo-controlled trial, 525 subjects with severe allergic asthma requiring daily inhaled corticosteroids were randomized to receive placebo or omalizumab subcutaneously every 2 or 4 weeks, depending on baseline IgE level and body weight. Inhaled corticosteroid doses. were kept stable over the initial 16 weeks of treatment and tapered during a further 12-week treatment period.Results: Omalizumab treatment resulted in significantly fewer asthma exacerbations per subject and in lower percentages of subjects experiencing an exacerbation than placebo treatment during the stable steroid phase (0.28 vs 0.54 [P=.006] and 14.6% vs 23.3% [P=.009], respectively) and during the steroid reduction phase (0.39 vs 0.66 [P=.003] and 21.3% vs 32.3% [P=.004], respectively). Beclomethasone dipropionate reduction was significantly greater with omalizumab treatment than with placebo (median 75% vs 50% [P