Volume 6 Supplement 1
Asthma diagnosis and treatment – 1015. Improvements in lung function in an indian population with IgE mediated asthma receiving omalizumab in a real-world setting
© Guleria et al; licensee BioMed Central Ltd. 2013
Published: 23 April 2013
Omalizumab is a recombinant humanized anti-IgE monoclonal antibody, indicated for add-on therapy for moderate- to severe-persistent allergic (IgE-mediated) asthma. Interim results at the 16 weeks time point of this 52 week study have previously been presented. We present a subgroup analysis looking at the efficacy of omalizumab at 16 weeks in relation to the serum IgE levels at baseline.
This open-label, multi-center, observational, prospective study, recruited 72 patients with moderate-to-severe persistent allergic asthma. Clinical efficacy was evaluated on the basis of improvement in asthma exacerbations, days missed at work/college, hospitalizations, ACQ 5, ACT scores, and FEV1. Safety and tolerability were also assessed. Qualitative and quantitative variables are analyzed using Chi-Square tests and paired t-tests, respectively. All parameters are comparing results at week 16 of omalizumab treatment with those at baseline.
Mean serum-IgE levels at baseline were 437.45 kIU L–1 (range 32-1599 kIU L–1). For analysis purposes patients were categorized into three groups, according to their baseline serum-IgE levels. Group 1 (n=31), comprised patients with baseline serum-IgE levels of 32-250 kIU L–1), and in group 2 (n=24) and 3 (n=17), patients with baseline serum-IgE levels of 251-600 and >600 kIU L–1; respectively. Mean (SD) age in three groups was 53.5 (9.6), 43.8 (15.3) and 60.5 (13.5) years; correspondingly. In group 1, FEV1 levels improved by 0.27 liters (0.88 vs. 1.15, 95%CI ; p=0.000) and in group 2 and 3 by 0.67 liters (1.32 vs. 2.00, 95%CI ; p=0.001) and by 0.55 liters (1.27 vs. 1.46, 95%CI ; p=0.002); respectively. Improvement in FEV1 levels was more prominent amongst patients with serum-IgE levels >600 kIU L–1. This change in FEV1 levels in 3 groups, was significantly different, as determined by one-way ANOVA (F (2,23)=7.959, p=0.002).
In these patients add-on therapy with omalizumab improved lung function, quality of life and other clinical measures. In this small sub group analysis, the improvement was more marked in patients with a higher IgE level at baseline.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.