Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma
Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma
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DOI：
10.1016/j.jaci.2012.07.047
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发表时间：
2013-01-01
影响因子：
14.2
通讯作者：
Bachert, Claus
中科院分区：
文献类型：
--
作者：
Gevaert, Philippe;Calus, Lien;Bachert, Claus
背景：成年鼻息肉患者通常患有哮喘，这对这些患者的生活质量造成了严重影响。鼻息肉和哮喘可能是治疗上的挑战；这两种疾病的炎症有许多共同特征，例如气道嗜酸性粒细胞增多、局部 IgE 形成和 T(H)2 细胞因子谱。奥马珠单抗是一种人类抗 IgE 单克隆抗体，已被证明对严重过敏性哮喘患者有效。奥马珠单抗可以成为鼻息肉合并哮喘患者的一种治疗选择。 目的：本研究的目的是探讨奥马珠单抗治疗鼻息肉合并哮喘患者的临床疗效。 方法：对患有鼻息肉合并哮喘的过敏性和非过敏性患者（n = 24）进行了一项随机、双盲、安慰剂对照研究。受试者接受 4 至 8 剂（皮下）奥马珠单抗 (n = 16) 或安慰剂 (n = 8)。主要终点是 16 周后鼻内窥镜息肉总评分降低。次要终点包括鼻窦计算机断层扫描、鼻腔和哮喘症状、验证问卷结果（简式健康问卷、31 项鼻窦炎结果测量仪和哮喘生活质量问卷）以及血清/鼻分泌物生物标志物水平的变化。 结果：奥马珠单抗治疗组 16 周后鼻内镜息肉总评分显着下降（-2.67，P = .001），通过计算机断层扫描（Lund-Mackay 评分）证实了这一点。无论是否存在过敏，奥马珠单抗对气道症状（鼻充血、前鼻漏、嗅觉丧失、喘息和呼吸困难）和生活质量评分均具有有益作用。结论：奥马珠单抗在治疗鼻息肉合并哮喘方面表现出临床疗效，支持气道中局部 IgE 形成的重要性和功能。 (J 过敏临床免疫学杂志 2013 年；131:110-6。)
Background: Adult patients with nasal polyps often have comorbid asthma, adding to the serious effect on the quality of life of these patients. Nasal polyps and asthma might represent a therapeutic challenge; inflammation in both diseases shares many features, such as airway eosinophilia, local IgE formation, and a T(H)2 cytokine profile. Omalizumab is a human anti-IgE mAb with proved efficacy in patients with severe allergic asthma. Omalizumab could be a treatment option for patients with nasal polyps and asthma.Objective: The goal of this study was to investigate the clinical efficacy of omalizumab in patients with nasal polyps and comorbid asthma.Methods: A randomized, double-blind, placebo-controlled study of allergic and nonallergic patients with nasal polyps and comorbid asthma (n = 24) was conducted. Subjects received 4 to 8 (subcutaneous) doses of omalizumab (n = 16) or placebo (n = 8). The primary end point was reduction in total nasal endoscopic polyp scores after 16 weeks. Secondary end points included a change in sinus computed tomographic scans, nasal and asthma symptoms, results of validated questionnaires (Short-Form Health Questionnaire, 31-item Rhinosinusitis Outcome Measuring Instrument, and Asthma Quality of Life Questionnaire), and serum/nasal secretion biomarker levels.Results: There was a significant decrease in total nasal endoscopic polyp scores after 16 weeks in the omalizumabtreated group (-2.67, P = .001), which was confirmed by means of computed tomographic scanning (Lund-Mackay score). Omalizumab had a beneficial effect on airway symptoms (nasal congestion, anterior rhinorrhea, loss of sense of smell, wheezing, and dyspnea) and on quality-of-life scores, irrespective of the presence of allergy.Conclusion: Omalizumab demonstrated clinical efficacy in the treatment of nasal polyps with comorbid asthma, supporting the importance and functionality of local IgE formation in the airways. (J Allergy Clin Immunol 2013;131:110-6.)