Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after three years of treatment
The Journal of Allergy and Clinical Immunology Feb 20, 2021
Busse WW, Bleecker ER, FitzGerald JM, et al. - The safety extension study BORA involved adults and adolescents experiencing severe asthma who finished the 48-week SIROCCO and 56-week CALIMA Phase III benralizumab trials, and continued safety as well as efficacy of benralizumab in the first year of BORA (Year 2 of treatment) has been documented, researchers herein present results for adolescents during Years 2 and 3 of treatment in BORA. Patients receiving regimens of benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W) in SIROCCO/CALIMA continued these treatment regimens in BORA (Q4W/Q4W and Q8W/Q8W, respectively), while re-randomization 1:1 of placebo patients was done to benralizumab (placebo/Q4W and placebo/Q8W, respectively) for 108 weeks. The rates of treatment-emergent adverse events (TEAEs) for Q4W and Q8W regimens were 68% and 74%, respectively, TEAEs resulting in discontinuation were 4% and 0% and, serious adverse events were 8% and 7% for these respective groups, and no deaths happened. Overall 69% Q8W patients were exacerbation-free in efficacy analyses. Overall, this 2-year extension study (up to 3 years of benralizumab treatment in adolescents) revealed safety and efficacy profiles which were consistent with previous findings.
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