Abstract
BackgroundA significant proportion of patients with severe asthma may also suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes. The biologic agent omalizumab is effective as add-on therapy in patients with severe allergic asthma. The aim of this post hoc analysis of the PROXIMA study was to compare the efficacy of omalizumab between patients with severe allergic asthma, with and without comorbid CRSwNP.MethodsPROXIMA was a prospective observational 2-part study conducted in Italy in adult patients with severe allergic asthma, where, in the second part, patients eligible for add-on omalizumab initiated treatment for 12 months. Patient baseline data such as comorbidities and history of exacerbations were collected. Outcomes were asthma control (Asthma Control Questionnaire [ACQ]), lung function (forced expiratory volume in 1 s [FEV1]) and exacerbation rate. The post hoc analysis compared these outcomes between the cohort with comorbid CRSwNP and the cohort without CRSwNP.ResultsOf 123 patients included in this analysis, 17 (13.8%) were in the CRSwNP cohort. There was no significant difference between cohorts in baseline clinical characteristics or in change from baseline at 12 months in ACQ values, % of predicted FEV1 or annual asthma exacerbation rate, although results were numerically in favor of the CRSwNP cohort versus the non-CRSwNP cohort. The proportion of patients who achieved an improvement in all three outcomes was numerically greater in the CRSwNP cohort (35.7% vs 23.0%).ConclusionsIn an observational real-world setting, add-on omalizumab for severe allergic asthma was effective in improving asthma control, lung function and in reducing exacerbations, including in those patients with CRSwNP.
Highlights
A significant proportion of patients with severe asthma may suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes
CRSwNP was present in 17 (13.8%) patients (10 female, mean (SD) age 51.6 ± 12.5 years). Their clinical and functional features did not differ from the cohort without CRSwNP (Table 2): in particular, baseline mean (SD) Asthma Control Questionnaire (ACQ) scores (2.87 ± 1.60 vs 2.98 ± 1.02, p = 0.7065), Forced expiratory volume in 1 s (FEV1) (1.74 ± 0.80 L vs 1.70 ± 0.72 L, p = 0.7347) and annual asthma exacerbation rate (5.13 ± 4.13 vs 4.54 ± 4.08, p = 0.4131) were similar in the two groups
In this post hoc analysis of the real-world PROXIMA study [9, 35], we evaluated the effectiveness of omalizumab in patients with severe allergic asthma in two cohorts stratified by the presence/absence of comorbid CRSwNP
Summary
A significant proportion of patients with severe asthma may suffer from nasal polyposis, which is commonly defined as chronic rhinosinusitis with nasal polyps (CRSwNP), the presence of which may adversely affect asthma treatment outcomes. The biologic agent omalizumab is effective as add-on therapy in patients with severe allergic asthma. The aim of this post hoc analysis of the PROXIMA study was to compare the efficacy of omalizumab between patients with severe allergic asthma, with and without comorbid CRSwNP. Disease control can be achieved in many patients with asthma through the chronic use of anti-inflammatory agents—usually inhaled corticosteroids [ICS]—frequently in combination with bronchodilators such as long-acting β2-agonists. A small proportion of patients continue to experience symptoms and frequent asthma exacerbations despite treatment with high-dose ICS in combination with other controller drugs and/or chronic use of oral corticosteroids (OCS): these patients are considered to have severe asthma [3]. Novel biologic drugs have been developed to treat severe asthma by targeting specific immunologic mechanisms [4], complying with the concepts of personalized and precision medicine [5]
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