Benralizumab (Fasenra, AstraZenecca) is an antieosinophil humanized monoclonal antibody that selectively targets the interleukin-5 receptor expressed on the surface of eosinophils.
It was approved in the US in 2017 based on phase-3 studies demonstrating improvements in multiple asthma clinical outcomes, including exacerbation rate and asthma symptoms for patients with poorly controlled severe eosinophilic asthma.
"The ANDHI phase 3b study increases confidence in the benralizumab mechanism of action for treating patients with severe eosinophilic asthma through further assessment of the onset and maintenance of clinical effects, benefits in health-related quality of life (HRQOL) measures, and the potential to treat symptoms of nasal polyposis for patients with chronic rhinosinusitis with nasal polyposis," Dr. Tim Harrison of the University of Nottingham, in the UK, and colleagues explain in The Lancet Respiratory Medicine.
The study enrolled 656 patients with severe eosinophilic asthma (blood eosinophil count at least 150 cells per uL) with 427 receiving benralizumab at 30 mg every eight weeks (first three doses given four weeks apart) and 229 receiving matching placebo for 24 weeks.
Baseline annualized asthma exacerbation rates were similar (3.2 in the benralizumab group and 3.1 in the placebo group).
Over 24 weeks, treatment with benralizumab led to a significant 49% reduction in the risk of asthma exacerbation, the primary efficacy measure, compared with placebo (rate ratio estimate, 0.51; P<0.0001), the researchers report.
Benralizumab also led to "clinically meaningful and statistically significant" improvement in the St. George's Respiratory Questionnaire (SGRQ) total score (least squares mean change from baseline, -8.11; P<0.0001), the key secondary endpoint, they note.
Improvements at week 24 with benralizumab were also noted for forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), Asthma Control Questionnaire 6 (ACQ-6) and clinician and patient global impression of change, with between-group differences observed as early as weeks one to four.
In addition, the study provides preliminary evidence of a beneficial effect of benralizumab on chronic rhinosinusitis symptoms in patients with asthma with nasal polyposis. A phase-3 confirmatory study of benralizumab treatment for patients with nasal polyposis (with or without asthma) is underway.
Adverse events such as headache, nasopharyngitis, sinusitis, pyrexia, and bronchitis were reported in 63 % of patients who received benralizumab and 62% of patients who received placebo. Mirroring prior studies, benralizumab was generally well tolerated with only six (1%) of 427 patients discontinuing treatment due to adverse events.
Dr. Harrison did not respond to a request for comment by press time.
AstraZeneca funded the trial. Several authors have financial relationships with the company.
SOURCE: https://bit.ly/3pOTc8U Lancet Respiratory Medicine, online December 22, 2020.
By Reuters Staff
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