Safety of biological drugs in the treatment of severe asthma - adverse effects in benralizumab therapy

Introduction: Eosinophils and IL-5 play a key role in the pathomechanism of asthma. This correlation led researchers to develop drugs targeting IL-5 and its receptors directly. A promising pharmaceutical from this group is Benralizumab -a monoclonal antibody binding to IL-5 receptors. Due to the limited knowledge of the effects of long-term eosinopenia (which is the effect of Benralizumab on the body), it was necessary to conduct studies on the safety of the drug. Aim: Assessment of safety in long-term Benralizumab treatment in severe asthma therapy. Materials and methods: Systematic review of adverse events during SIROCCO, CALIMA, ZONDA, BORA and MELTEMI Benralizumab safety studies. Results: During the previous studies (SIROCCO, CALIMA, ZONDA), among the study participants, adverse events occurred in 1330 (64,8%) patients receiving Benralizumab and 723 (35,2%) receiving sham treatment. During BORA's expansion, adverse events occurred in another 1089 (69,1%) patients. During the 5-year observation period of the MELTEMI study, a further 401 adverse events were recorded among the 446 participants in the program. The vast majority of recorded adverse events were upper respiratory tract infections, exacerbations of asthma, or bronchitis. During the studies and as part of the follow-up of patients after their completion, cancer (classified as one of the adverse events) was diagnosed in 25 (0.9%) patients participating in the tests. Conclusions: The conducted research does not show a significant increase in the incidence of adverse events in the course of long-term therapy with Benralizumab in patients with severe bronchial asthma. Further monitoring of prolonged eosinopenia on the health status of patients treated with Benralizumab is required.