Study Tests Effectiveness of Omalizumab in Treating Perennial Severe Allergic Asthma

Study Tests Effectiveness of Omalizumab in Treating Perennial Severe Allergic Asthma

A new study exploring perennial severe allergic asthma entitled “Prevalence of perennial severe allergic asthma in Italy and effectiveness of omalizumab in its management: PROXIMA – an observational, 2 phase, patient reported outcomes study was published this July in Clinical and Molecular Allergy. The study consisted of the evaluation of the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence in patients treated with omalizumab in an Italian population.

Asthma is a common chronic condition of the airways that is complex and characterized by variable and regular symptoms, airflow obstruction, bronchial hyper responsiveness and inflammation. Asthma may be classified clinically on the basis of various parameters including the atopic status of the individual, the degree of airway obstruction, or the nature of trigger factors. Globally, asthma affects more than 300 million people within this population around 10% are estimated to suffer from severe asthma, contributing to a considerable burden of morbidity and mortality. In patients with allergic asthma there are significantly higher levels of IgE antibodies, which induce chronic airway inflammation by high-affinity (FcεRI) or low-affinity (FcεRII) IgE receptors found on cells such as mast cells and basophils.

The GEIRD Study performed in the Italian population found that the average incidence of asthma was reported to be 6.6%, reporting an increase of 35% in the last twenty years. The differences between seasonal and perennial allergic asthma based on seasonality of allergens has been a matter of discussion among physicians because of some coinciding features of allergens.

For the first time, a study, the PROXIMA study (Patient-Reported Outcomes and Xolair ® In the Management of Asthma), was conceived to evaluate the percentage of individuals with severe asthma sensitive to perennial allergens, indoor allergens such as dust, pet dander or mold, and to evaluate asthma control and therapy adherence during 12 months in patients treated with omalizumab in Italian population. Additionally, they analyzed protein biomarkers and correlated them with severe allergic asthma and therapy effects using proteomic approach.

In several clinical studies with omalizumab, recombinant monoclonal antibodies (IgE antibody), revealed a considerable improvement in asthma control and reduced exacerbations in patients with severe allergic asthma episodes. This study was performed in a real-world setting in Italy. The findings from this study will further confirm the control of asthma achieved and maintained by omalizumab therapy in this population. Moreover, the identification of biomarkers by proteomic analysis may reveal potential proteins associated with a type of response and therapy by patients with asthma. The data will help in identification and characterization of best responders to this therapy and may lead in the future to a tailored-made approach medicine.

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