Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma

被引:619
作者
Gevaert, Philippe [1 ]
Calus, Lien [1 ]
Van Zele, Thibaut [1 ]
Blomme, Katrien [1 ]
De Ruyck, Natalie [1 ]
Bauters, Wouter [2 ]
Hellings, Peter [4 ]
Brusselle, Guy [3 ]
De Bacquer, Dirk [5 ]
van Cauwenberge, Paul [1 ]
Bachert, Claus [1 ]
机构
[1] Ghent Univ Hosp, Upper Airways Res Lab, Dept Otorhinolaryngol, B-9000 Ghent, Belgium
[2] Ghent Univ Hosp, Dept Radiol, B-9000 Ghent, Belgium
[3] Ghent Univ Hosp, Dept Resp Med, B-9000 Ghent, Belgium
[4] Univ Hosp Leuven, Dept Otorhinolaryngol, Louvain, Belgium
[5] Univ Ghent, Dept Publ Hlth, Ghent, Belgium
关键词
Omalizumab; anti-IgE; local IgE; nasal polyposis; asthma; quality of life; STAPHYLOCOCCUS-AUREUS ENTEROTOXINS; ANTI-IGE; EXPRESSION; ANTIBODIES; THERAPY; INFLAMMATION; SINUSITIS; PROTEIN; SAFETY; ADULTS;
D O I
10.1016/j.jaci.2012.07.047
中图分类号
R392 [医学免疫学];
学科分类号
100108 [医学免疫学];
摘要
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.)
引用
收藏
页码:110 / U166
页数:8
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