INTERNATIONAL SAFETY PROFILE FOR THE USE OF OMALIZUMAB IN CLINICAL PRACTICE

Abstract

The article provides an overview of information on cases of adverse reactions with the use of omalizumab, the reports of which are included in the database of the World Health Organization's international drug monitoring program in 6 years (selected period 01.01.2017-01.01.2024). An analysis of the safety indicators of omalizumab, which is the drug of choice in the treatment of a number of severe atopic diseases, was carried out. Despite the long-term use of the drug in medical practice (more than 15 years) and reports on its efficacy, there is insufficient information on adverse reactions during its use, especially in the Russian Federation, since long-term clinical monitoring has not been carried out. The obtained characteristics of the structure of adverse reactions to the use of omalizumab by gender, age of patients, nature of their complaints, severity of outcomes, geography and initiators of reports, constitute a theoretical basis for improving and fine-tuning the domestic system of pharmacovigilance and drug monitoring, and may also be of practical interest to doctors, researchers and health regulators. The first rank places in the structure of adverse reactions to omalizumab are occupied by: general disorders and reactions at the site of administration, disorders of the skin and subcutaneous tissue, disorders of the respiratory system, thoracic and mediastinal organs, injuries, intoxication and complications of procedures, disorders of the nervous system. In the overall structure of NR, serious adverse reactions to omalizumab accounted for 35,1%. The analysis showed that in the assessment of adverse reactions, a significant role is given to patients (their representatives), whose opinion is determined by subjective feelings and the level of awareness, so more attention should be paid to drug informing patients.