Division of Respiratory Medicine, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Allergol Int. 2010 Jun;59(2):167-74. doi: 10.2332/allergolint.09-OA-0137. Epub 2010 Feb 25.
We have previously demonstrated that addition of omalizumab to standard therapy improved asthma control by significantly improving lung function and reducing asthma exacerbations in Japanese patients with moderate-to-severe asthma. The aim of this study was to evaluate the effects of omalizumab on long-term disease control in Japanese patients with moderate-to-severe persistent asthma.
An open-label, 48-week study was conducted in 133 Japanese patients with moderate-to-severe persistent asthma. Omalizumab was administered subcutaneously every 2 or 4 weeks based on serum IgE level and body weight in each patient.
Treatment with omalizumab significantly improved lung function. A subgroup of patients with inadequately controlled severe persistent asthma, despite high dose inhaled corticosteroids and other multiple controller therapies, which corresponds to the Japanese label (label population), showed greater improvements in morning PEF and FEV(1) than the whole study population (full Analysis Set). Serum free IgE levels decreased to below the target and were maintained during the treatment period in almost all patients. The majority of adverse events were mild-to-moderate in severity and there was no trend toward an increase in incidence of adverse events with increase in duration of omalizumab. In addition, the profile of adverse events in this study was similar to that in a 16-week, placebo-controlled study which the present authors had conducted previously in Japan. There were no anaphylactic reactions and no anti-omalizumab antibodies were detected.
Long-term treatment with omalizumab is effective and well tolerated in Japanese patients with moderate-to-severe persistent asthma.
我们之前已经证明，奥马珠单抗联合标准疗法可以通过显著改善肺功能和减少中重度哮喘日本患者的哮喘恶化来改善哮喘控制。本研究的目的是评估奥马珠单抗对中重度持续性哮喘日本患者长期疾病控制的影响。
一项开放标签、48 周的研究纳入了 133 名中重度持续性哮喘日本患者。根据每位患者的血清 IgE 水平和体重，奥马珠单抗每 2 或 4 周皮下给药。
奥马珠单抗治疗显著改善了肺功能。在未能充分控制的重度持续性哮喘亚组中，尽管使用了高剂量吸入皮质激素和其他多种控制药物，但仍有更多患者的清晨 PEF 和 FEV1 得到了改善，该亚组对应于日本标签（标签人群）。与整个研究人群（全分析集）相比。血清游离 IgE 水平降至目标以下，并在治疗期间得到维持。大多数不良事件的严重程度为轻度至中度，且奥马珠单抗治疗时间延长并没有增加不良事件的发生率。此外，本研究的不良事件谱与作者之前在日本进行的为期 16 周、安慰剂对照研究相似。没有发生过敏反应，也没有检测到抗奥马珠单抗抗体。
奥马珠单抗长期治疗可有效改善中重度持续性哮喘日本患者的病情，且具有良好的耐受性。
