Benralizumab Demonstrates Safety, Efficacy at 3 Years for Moderate-to-Severe Asthma

By Jeff Craven /alert Contributor
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At 3 years, benralizumab (Fasenra; AstraZeneca) continues to lower exacerbation rates and improve lung function in adults and adolescents with severe, uncontrolled asthma, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

“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,” William W. Busse, MD, professor of allergy and immunology at the University of Wisconsin Medical School in Madison, Wisconsin, and colleagues wrote in their study abstract.

BORA is a phase 3 extension trial of adults and adolescents in the SIROCCO and CALIMA studies who were taking inhaled corticosteroids plus a long-acting β2 agonist in addition to benralizumab or placebo. SIROCCO was a 48-week study, and CALIMA lasted for 52 weeks, at which point patients could enter BORA for a 2-year extension study. Results from the first year of the BORA phase 3 extension trial, where patients experienced 2 years of total treatment with benralizumab, were recently published in The Lancet Respiratory Medicine.

Busse and colleagues reporting on 2-year outcomes from BORA, or 3 years of total treatment with benralizumab, in their abstract. There were 86 patients from SIROCCO and CALIMA taking benralizumab at a dose of 30 mg every 4 weeks (25 patients) or every 8 weeks (61 patients) who transitioned to the BORA extension study, where they maintained their treatment regimens for up to 108 weeks. Patients who received placebo in SIROCCO or CALIMA were randomized to the 4-week or 8-week benralizumab group in BORA. The researchers measured the safety of benralizumab as a primary outcome, with secondary outcomes of annual exacerbation rate as well as change from baseline in prebronchodilator forced expiratory volume in 1 second (FEV1).

There were 69 patients who reached the end of the BORA extension trial, including 51 patients in the 8-week benralizumab group. The safety findings in BORA were consistent with the parent trials, with 17 of 25 patients (68%) in the 4-week group experiencing a treatment-emergent adverse event compared with 46 of 61 patients (74%) in the 8-week group. One patient (4%) in the 4-week group discontinued the trial due to treatment-related adverse events, while there were no discontinuations or deaths in the 8-week group. Serious adverse events occurred for 2 of 25 patients (8%) in the 4-week group and 4 of 61 patients (7%) in the 8-week group.

Treatment efficacy was also similar in BORA to the parent trials, with 42 of 61 patients (69%) in the 8-week group having no exacerbations within 3 years of treatment, which included 18 of 29 patients (62%) who transitioned from placebo to benralizumab and 24 of 32 patients (75%) who remained on their dosing regimen throughout the parent trial and the extension study. Regarding change from baseline in prebronchodilator FEV1, the mean change at 108 weeks was 0.327 L in the group who transitioned from placebo to the 8-week benralizumab group, and 0.323 L for patients who stayed on the 8-week regimen.

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