Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma
Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma
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DOI：
10.1111/j.1398-9995.2004.00533.x
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发表时间：
2004-07-01
期刊：
影响因子：
12.4
通讯作者：
Fox, H
中科院分区：
文献类型：
--
作者：
Ayres, JG;Higgins, B;Fox, H
背景：哮喘控制不佳的患者有较高的发病率和死亡率。本研究评价了奥马珠单抗在控制不佳、中度至重度过敏性asthma.Methods患者中的疗效和耐受性：这是一项随机、开放标签、多中心、平行组研究。共纳入312例接受大于或等于400 mug/d（青少年）或大于或等于800 mug/d（成人）吸入性二丙酸倍氯米松或等效药物的患者（12-73岁）。患者接受最佳标准治疗（BSC）联合或不联合奥马珠单抗[每4周至少0.016 mg/kg/IgE（IU/ml）]治疗12个月。结果：哮喘恶化相关事件的年平均数从BSC单药治疗的9.76例（n = 106）降至奥马珠单抗治疗的4.92例（n = 206）（P < 0.001）。平均临床显著哮喘加重率分别为2.86和1.12/患者年（P < 0.001）。奥马珠单抗治疗患者（41.4%）需要急救药物
Background: Patients with poorly controlled asthma have greater morbidity and mortality. This study evaluated the efficacy and tolerability of omalizumab in patients with poorly controlled, moderate-to-severe allergic asthma.Methods: This was a randomized, open-label, multicentre, parallel-group study. A total of 312 patients (12-73 years) receiving greater than or equal to400 mug/day (adolescent) or greater than or equal to800 mug/day (adult) inhaled beclomethasone dipropionate, or equivalent were included. Patients received best standard care (BSC) with or without omalizumab [at least 0.016 mg/kg/IgE (IU/ml) every 4 weeks] for 12 months.results: The annualized mean number of asthma deterioration-related incidents was reduced from 9.76 with BSC alone (n = 106) to 4.92 per patient-year with omalizumab (n = 206) (P < 0.001). Mean clinically significant asthma exacerbation rates were 2.86 and 1.12 per patient-year, respectively (P < 0.001). Omalizumab-treated patients (41.4%) required rescue medication