Researchers find out in a recent study that omalizumab provides benefit to patients with moderate to severe allergic asthma, regardless of body mass index.
Being overweight and obese are risk factors for both early and late onset asthma. Obesity is associated with the severity of asthma and contributes toward a more difficult to control asthma phenotype.
Increasing body mass index (BMI) is associated with reduced efficacy of conventional asthma treatments, such as inhaled corticosteroids, systemic glucocorticoids, and inhaled corticosteroids long acting B2 agonist combinations. Biologics approved for use in patients with treatment resistant asthma target immunoglobulin E (IgE; omalizumab), interleukin (IL)-5 (mepolizumab, reslizumab) or its receptor (IL-5Rα; benralizumab), or the IL-4 receptor (IL-4Rα; dupilumab) and some studies have suggested that biologics may not be as effective in patients with higher BMIs. The reasons for this are unclear but may relate to differences in underlying inflammatory pathways, pharmacokinetics, or other biological factors related to obesity.
Omalizumab is a recombinant humanized monoclonal antibody that binds IgE at the same site as the high-affinity IgE receptor, quickly reducing the circulating levels of free IgE. Therefore, allergens will not be recognized by effector cells, such as mast cells, eosinophils, macrophages, and dendritic cells, impeding the activation of these cells and subsequent release of active mediators.
Researchers carried out a pooled analysis that used data from patients aged 18 to 75 years in the phase 3 studies 008 and 009. Studies 008 and 009 were double-blind, placebo-controlled, multicenter studies that recruited patients aged 12 to 75 years with moderate-to-severe allergic asthma who were symptomatic despite treatment with inhaled corticosteroids .
Response to omalizumab relative to placebo was evaluated for reduction in exacerbation rate, change from baseline in forced expiratory volume in 1 second (FEV1), beclomethasone dipropionate dose, and the proportions of patients able to reduce their BDP dose by 50% or 100% (completely eliminated), Total Asthma Symptom Score (TASS), and Asthma Quality of Life Questionnaire (AQLQ) score.
Total 995 patients who were included from studies 397 patients were categorized as normal or underweight, 330 as overweight and 268 as obese.
Study said, pooled analysis of the omalizumab pivotal trials, omalizumab reduced asthma exacerbations and BDP dose and improved lung function, asthma symptom score, and asthma-related QoL across all BMI categories compared with placebo.
Authors concluded that obese patients had a greater reduction in exacerbations, and nominal improvement in symptoms, than patients with a normal or overweight BMI. There were no differences between BMI categories with regard to FEV1 improvement or BDP dose reduction. The totality of the data suggests that improvements after omalizumab treatment are irrespective of BMI.
The study is published in Annals of Allergy, Asthma & Immunology.
