POTENTIAL OF THE DOMESTIC BIOSIMILE OMALIZUMAB IN ACHIEVEMENT OF CONTROL IN PATIENTS WITH SEVERE ASTHMA.

Abstract

Background. Severe atopic asthma is a medical and social problem due to its prevalence, the tendency to exacerbations, the impact on the quality of life and on the work ability, and high treatment costs. The appearance biosimilar omalizumab among biologicals makes such therapy more accessible to patients. This article presents the results of an open prospective clinical study of the biosimilar omalizumab - Genolar® in patients with the severe atopic asthma. Aims: To evaluate the efficacy and tolerability of the domestically produced biosimilar omalizumab in the real clinical practice. Materials and methods. The study involved 15 adult patients (19-66 years) with a reliable history consistent with moderate to severe atopic asthma who hadn`t have asthma control at the time of inclusion in the study. All patients received the Genolar® (omalizumab, Generic JSC, Russia) for 52 weeks at the dose calculated according to the instructions. The efficacy was evaluated taking into account changes in symptom severity, improved asthma control using the Asthma Control Questionnaire (ACQ-5), pulmonary function tests, peak flow measurements, assessment the asthma exacerbations number and the healthcare resources use. Results. According to our study results, all patients demonstrated a decrease in the night and daytime attacks frequency and the shortness of breath severity due to omalizumab, which made it possible to reduce the basic therapy and refuse systemic glucocorticosteroids using in patients who previously received their. After 6 months we obtained an improvement in the asthma symptoms control (Δ ACQ-5=(-1.87), p=0.0002 compared to baseline with a trend towards further improvement in indicators and reached Δ ACQ-5=(-2.18), p=0.0001 to the 52nd week). We also obtained a statistically significant improvement in pulmonary function (after a year of treatment, the increase in forced expiratory volume in the first second was +19.85% compared to baseline, p=0.0001). No asthma exacerbation was registered during 12 months omalizumab treatment. Conclusions. Our study showed that the biosimilar Genolar® treatment in patients with severe atopic asthma allowed to achieve asthma control, decrease the exacerbations number and reduce the basic therapy volume, including oral-corticosteroid elimination.