ABS38: Add-on omalizumab significantly improves quality of life in patients with severe persistent allergic (IgE-mediated) asthma

Abstract

Patients with severe persistent allergic asthma experience frequent serious exacerbations and daily symptoms that diminish health-related quality of life (QoL). To evaluate effects on QoL of add-on omalizumab, an anti-IgE therapy. Subjects and method: A pooled analysis of data from six controlled clinical trials of omalizumab in asthma patients (96% having severe persistent asthma) was conducted. Omalizumab was addedto current asthma therapy and compared with placebo (five double-blind studies) or with current therapy alone (one open-label study). Asthma-related QoL was assessed at baseline and endpoint using the Juniper Asthma Quality of Life Questionnaire (AQLQ). Change from baseline in AQLQ overall score was compared between treatments using analysis of covariance methods. Percentages of omalizumab- and control-treated patients achieving clinically meaningful (=0.5-point) improvement in AQLQ overall score were compared using Mantel-Haenszel chi-square tests. Additionally, QoL data were separately evaluated from one study included in the pooled analysis: INNOVATE, a 28-week randomized double-blind study which exclusively enrolled patients for whom omalizumab is indicated in the EU (patients with severe persistent allergic asthma that is inadequately controlled despite high dose ICS plus LABA). QoL data were available from 2,548 patients (pooled analysis: omalizumab n = 1,342, control n = 1,206) and 419 patients (INNOVATE). Add-on omalizumab produced significantly greater improvements than control (p < 0.01, both analyses) for each individual AQLQ domain and overall score. Significantly more omalizumab patients achieved clinically meaningful (=0.5-point) improvement in AQLQ overall score at endpoint versus baseline than control patients (pooled analysis: 66.3% vs 52.4%, p < 0.001; INNOVATE: 60.8% vs 47.8%, p =0.008). Add-on omalizumab improves QoL to a significant and clinically meaningful level in patients with severe persistent allergic asthma. Moreover, similar results were obtained in a population of patients with inadequately controlled severe persistent allergic asthma despite receiving high-dose ICS and LABA. Conflict of interest and funding Supported by Novartis Pharma AG.