Asthma Treatment Is Safe, Effective for Youth for up to 3 Years
Benralizumab, 30 mg, is safe and effective for adolescents with asthma for up to 3 years of treatment, according to new data from the BORA trial.
The BORA trial included 86 adolescents who had completed the SIROCCO and CALIMA phase 3 trials of benralizumab. During SIRROCCO and CALIMA, participants received either 4 weeks or 8 weeks of benralizumab, 30 mg.
In BORA, the participants had continued their regimen of benralizumab, 30 mg, for 108 weeks. Then the researchers assessed for safety, annual asthma exacerbation rate, and change from baseline in prebronchodilator forced expiratory volume in 1 second (pre-FEV1).
Results confirmed previous findings; treatment-emergent adverse events were 74% in the 8-week group and 68% in the 4-week group; serious adverse events were 7% in the 8-week group and 8% in the 4-week group.
“Safety and efficacy profiles in this 2 year extension study, representing up to 3 years of benralizumab treatment in adolescents, were consistent with previous findings,” the researchers concluded.
Busse W, Bleecker E, FitzGerald JM, et al. Three-year safety and efficacy of benralizumab for adolescent patients with severe, uncontrolled asthma: results of the BORA Extension Study. Paper presented at: American Academy of Allergy Asthma & Immunology Annual Meeting 2020; March 13-16, 2020; Virtual. Accessed March 15, 2020. https://www.jacionline.org/article/S0091-6749(19)32065-2/fulltext