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

• Published in: Journal of allergy and clinical immunology Vol. 131; no. 1; pp. 110 - 116.e1
• Main Authors: Gevaert, Philippe, Calus, Lien, Van Zele, Thibaut, Blomme, Katrien, De Ruyck, Natalie, Bauters, Wouter, Hellings, Peter, Brusselle, Guy, De Bacquer, Dirk, van Cauwenberge, Paul, Bachert, Claus
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.01.2013; Elsevier; Elsevier Limited
• Subjects: Adult; adults; Allergies; Allergy and Immunology; Anti-Allergic Agents - adverse effects; Anti-Allergic Agents - therapeutic use; anti-IgE; Antibodies, Anti-Idiotypic - adverse effects; Antibodies, Anti-Idiotypic - therapeutic use; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Asthma; Asthma - complications; Asthma - drug therapy; Asthma - immunology; Biological and medical sciences; biomarkers; blood serum; Clinical trials; Comorbidity; Computed tomography; Cytokines; Drug therapy; Dyspnea; Ear diseases; Eosinophilia; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Helper cells; Hospitals; Humans; Hypersensitivity; Immunoglobulin E; Immunopathology; Inflammation; Inventories; local IgE; Lymphocytes T; Male; Medical sciences; Mental health; Middle Aged; Monoclonal antibodies; nasal polyposis; Nasal Polyps - complications; Nasal Polyps - drug therapy; Nasal Polyps - immunology; Nose; Olfaction; Omalizumab; Otolaryngology; Otorhinolaryngology. Stomatology; patients; placebos; Polyps; polyps (pathological conditions); Quality of life; questionnaires; Respiration; Respiratory tract; rhinosinusitis; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Scanning; secretion; Sinus; smell; Treatment Outcome; Tumors; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Wheezing; United States > US; SEs; local IgE; Omalizumab; asthma; CRSwNP; AQLQ; nasal polyposis; SF-36; CT; anti-IgE; RSOM-31; TPS; quality of life; Staphylococcus aureus enterotoxins; Asthma Quality of Life Questionnaire; Chronic rhinosinusitis with nasal polyposis; Computed tomography; 31-Item Rhinosinusitis Outcome Measuring Instrument; Short-Form Health Questionnaire; Total nasal endoscopic polyp score; Human; Lung disease; Allergy; Immunopathology; Nose disease; Nasal polyp; Upper respiratory tract; Respiratory disease; IgE; Monoclonal antibody; Asthma; Quality of life; Immunology; Efficiency; Nasal polyposis; ENT disease; Bronchus disease; Obstructive pulmonary disease
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2012.07.047

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 TH2 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. The goal of this study was to investigate the clinical efficacy of omalizumab in patients with nasal polyps and comorbid asthma. 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. There was a significant decrease in total nasal endoscopic polyp scores after 16 weeks in the omalizumab-treated 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. 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.