4.7 Article

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

Journal

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume 131, Issue 1, Pages 110-U166

Publisher

MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2012.07.047

Keywords

Omalizumab; anti-IgE; local IgE; nasal polyposis; asthma; quality of life

Funding

  1. Ghent University
  2. Flemish Scientific Research Board
  3. Belgian Research Fund [B/11005/02]
  4. Flemish Scientific Research Board [A12/5-HB-KH3, G.0436.04]
  5. Interuniversity Attraction Poles program (IUAP)-Belgian state-Belgian Science Policy [P6/35]
  6. Global Allergy and Asthma European Network (GA2LEN)
  7. Novartis

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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.)

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