Omalizumab Is Effective In Allergic And Non-allergic Patients With Nasal Polyps And Asthma

Abstract

RationaleAdult patients with nasal polyps often suffer from comorbid asthma, adding to the serious impact on quality of life of these patients. Nasal polyps and asthma may represent a therapeutic challenge. Omalizumab is a human monoclonal anti-IgE antibody with proven efficacy in severe allergic asthma. The goal of this study was to investigate the clinical efficacy of omalizumab in patients with nasal polyps and comorbid asthma.MethodsA randomized double-blind, placebo-controlled study of 24 patients with nasal polyps and comorbid asthma was conducted. Subjects received 4 to 8 (subcutaneous) doses of Omalizumab (n=16) or placebo (n=8) depending on serum IgE concentrations (30-700kU/l) and body weight. The primary endpoint was the reduction of the total nasal endoscopic polyp score after 16 weeks. Secondary endpoints included a change in sinus CT-scan, nasal and asthma symptoms, validated questionnaires (SF-36, RSOM-31 and AQLQ) and serum/nasal secretion biomarkers.ResultsThere was a significant decrease in total nasal endoscopic polyp score after 16 weeks in the omalizumab-treated group compared to placebo (-2.67; P=0.001), which was confirmed by CT-scan (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 the quality of life scores, irrespective of the presecnce of allergy.ConclusionsOmalizumab demonstrated clinical efficacy in the treatment of allergic and non-allergic patients with nasal polyps and asthma, supporting the importance and functionality of local IgE formation in the airways. RationaleAdult patients with nasal polyps often suffer from comorbid asthma, adding to the serious impact on quality of life of these patients. Nasal polyps and asthma may represent a therapeutic challenge. Omalizumab is a human monoclonal anti-IgE antibody with proven efficacy in severe allergic asthma. The goal of this study was to investigate the clinical efficacy of omalizumab in patients with nasal polyps and comorbid asthma. Adult patients with nasal polyps often suffer from comorbid asthma, adding to the serious impact on quality of life of these patients. Nasal polyps and asthma may represent a therapeutic challenge. Omalizumab is a human monoclonal anti-IgE antibody with proven efficacy in severe allergic asthma. The goal of this study was to investigate the clinical efficacy of omalizumab in patients with nasal polyps and comorbid asthma. MethodsA randomized double-blind, placebo-controlled study of 24 patients with nasal polyps and comorbid asthma was conducted. Subjects received 4 to 8 (subcutaneous) doses of Omalizumab (n=16) or placebo (n=8) depending on serum IgE concentrations (30-700kU/l) and body weight. The primary endpoint was the reduction of the total nasal endoscopic polyp score after 16 weeks. Secondary endpoints included a change in sinus CT-scan, nasal and asthma symptoms, validated questionnaires (SF-36, RSOM-31 and AQLQ) and serum/nasal secretion biomarkers. A randomized double-blind, placebo-controlled study of 24 patients with nasal polyps and comorbid asthma was conducted. Subjects received 4 to 8 (subcutaneous) doses of Omalizumab (n=16) or placebo (n=8) depending on serum IgE concentrations (30-700kU/l) and body weight. The primary endpoint was the reduction of the total nasal endoscopic polyp score after 16 weeks. Secondary endpoints included a change in sinus CT-scan, nasal and asthma symptoms, validated questionnaires (SF-36, RSOM-31 and AQLQ) and serum/nasal secretion biomarkers. ResultsThere was a significant decrease in total nasal endoscopic polyp score after 16 weeks in the omalizumab-treated group compared to placebo (-2.67; P=0.001), which was confirmed by CT-scan (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 the quality of life scores, irrespective of the presecnce of allergy. There was a significant decrease in total nasal endoscopic polyp score after 16 weeks in the omalizumab-treated group compared to placebo (-2.67; P=0.001), which was confirmed by CT-scan (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 the quality of life scores, irrespective of the presecnce of allergy. ConclusionsOmalizumab demonstrated clinical efficacy in the treatment of allergic and non-allergic patients with nasal polyps and asthma, supporting the importance and functionality of local IgE formation in the airways. Omalizumab demonstrated clinical efficacy in the treatment of allergic and non-allergic patients with nasal polyps and asthma, supporting the importance and functionality of local IgE formation in the airways.