2-year safety and efficacy results for benralizumab

Abstract

The era of biological therapies for asthma started with approval in 2003 of a humanised anti-IgE antibody, omalizumab, for the treatment of patients with severe allergic asthma. Since then, IgG antibodies targeting interleukin (IL)-5 (mepolizumab and reslizumab) and IL-5 receptor α (benralizumab) have been approved for the treatment of patients with severe eosinophilic asthma characterised by recurrent exacerbations. In 2016, two phase 3 studies 1 Bleecker ER FitzGerald JM Chanez P et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016; 388: 2115-2127 Summary Full Text Full Text PDF PubMed Scopus (850) Google Scholar , 2 FitzGerald JM Bleecker ER Nair P et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016; 388: 2128-2141 Summary Full Text Full Text PDF PubMed Scopus (870) Google Scholar showed that benralizumab had good safety and efficacy when administered over 1 year in patients with severe uncontrolled asthma, reducing asthma exacerbations and improving lung function in patients with blood eosinophil counts of 300 cells per μL or greater at baseline. Although 1-year safety results for anti-IL-5 or anti-IL-5 receptor α antibodies have generally been acceptable, 3 He LL Zhang L Jiang L Xu F Fei DS Efficacy and safety of anti-interleukin-5 therapy in patients with asthma: a pairwise and Bayesian network meta-analysis. Int Immunopharmacol. 2018; 64: 223-231 Crossref PubMed Scopus (13) Google Scholar no study has assessed their long-term safety or efficacy. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trialThe 2 years of safety results validate that observations observed in the first year of benralizumab continued through a second year of treatment. No new consequences of long-term eosinophil depletion occurred, and the incidence of other adverse events, including opportunistic infections, were similar during the second year. Full-Text PDF