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

Philippe Gevaert (UGent) , LIEN CALUS (UGent) , Thibaut Van Zele (UGent) , Katrien Blomme (UGent) , Natalie De Ruyck (UGent) , Wouter Bauters (UGent) , Peter Hellings, Guy Brusselle (UGent) , Dirk De Bacquer (UGent) , Paul Van Cauwenberge (UGent) , et al.
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Abstract
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.
Keywords
PROTEIN, CHILDREN, ANTI-IGE, CHRONIC SINUSITIS, EXPRESSION, INFLAMMATION, ANTIBODIES, THERAPY, RHINOSINUSITIS, STAPHYLOCOCCUS-AUREUS ENTEROTOXINS, quality of life, asthma, nasal polyposis, anti-IgE, local IgE, Omalizumab

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Chicago
Gevaert, Philippe, LIEN CALUS, Thibaut Van Zele, Katrien Blomme, Natalie De Ruyck, Wouter Bauters, Peter Hellings, et al. 2013. “Omalizumab Is Effective in Allergic and Nonallergic Patients with Nasal Polyps and Asthma.” Journal of Allergy and Clinical Immunology 131 (1): 110–U166.
APA
Gevaert, Philippe, CALUS, L., Van Zele, T., Blomme, K., De Ruyck, N., Bauters, W., Hellings, P., et al. (2013). Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 131(1), 110–U166.
Vancouver
1.
Gevaert P, CALUS L, Van Zele T, Blomme K, De Ruyck N, Bauters W, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY. 2013;131(1):110–U166.
MLA
Gevaert, Philippe, LIEN CALUS, Thibaut Van Zele, et al. “Omalizumab Is Effective in Allergic and Nonallergic Patients with Nasal Polyps and Asthma.” JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY 131.1 (2013): 110–U166. Print.
@article{3139229,
  abstract     = {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.},
  author       = {Gevaert, Philippe and CALUS, LIEN and Van Zele, Thibaut and Blomme, Katrien and De Ruyck, Natalie and Bauters, Wouter and Hellings, Peter and Brusselle, Guy and De Bacquer, Dirk and Van Cauwenberge, Paul and Bachert, Claus},
  issn         = {0091-6749},
  journal      = {JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY},
  language     = {eng},
  number       = {1},
  pages        = {110--U166},
  title        = {Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma},
  url          = {http://dx.doi.org/10.1016/j.jaci.2012.07.047},
  volume       = {131},
  year         = {2013},
}

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