A phase 3b clinical trial studying benralizumab as a treatment for asthma and nasal polyps found the treatment provided benefits in several areas, including lung function and nasal polyps symptoms.
The ANDHI trial included adults with severe eosinophilic asthma with at least two exacerbations the year before the study while using high-dose inhaled corticosteroid and other controllers. Those who met the eligibility criteria were randomized to receive either 30 mg of benralizumab every eight weeks or matched placebo for 24 weeks.
The primary endpoint of the trial was annualized exacerbation rate, with rate ratio calculated over approximately 24 weeks of follow-up. Secondary endpoints included change from baseline to week 24 in St. George’s Respiratory Questionnaire (SGRQ) total score, peak expiratory flow change, and Sino-Nasal Outcome Test-22 (SNOT-22).
According to results published in The Lancet, benralizumab reduced exacerbation by 49% compared with placebo (RR estimate 0.51, 95% CI, 0.39-0.65; p<0.0001) over the 24-week treatment period. Patients in the drug arm also reported improvement in SGRQ total score versus placebo (least squares mean change from baseline 8.11; 95% CI, -11.41 to -4.82; p<0.0001). Benralizumab also improved other factors, including FEV, PEF, and SNOT-22 at week 24 versus placebo. Some of the factors examined saw early differences in the first four weeks of treatment.
The authors said they believe their research “increases confidence” in benralizumab as a treatment for patients with eosinophilic asthma by looking at health-related quality of life measures and the ability to successfully treat nasal polyps.
“These results support and extend the known benefits of eosinophil depletion by benralizumab for the treatment of severe eosinophilic asthma to include early and sustained improvement in disease-specific HRQOL and patient-reported outcomes, in addition to lung function and asthma control,” the authors said.
The most commonly reported adverse events in the drug arm included nasopharyngitis, headache, sinusitis, bronchitis, and pyrexia. The authors noted that there were fewer serious adverse events reported in the drug arm compared to placebo (5% vs. 11%). The only common serious adverse event, which was experienced by >1% of patients, was worsening of asthma, which was reported in 2% of patients in the drug arm and 4% in the placebo arm.
While the trial was 24 weeks long, the authors noted many patients in the drug arm achieved maximal benefit by week 12, which they said was an added advantage of the treatment. They also suggest more studies should be conducted looking at the impact of benralizumab for patients with chronic rhinosinusitis with nasal polyposis with and without severe eosinophilic asthma.
“Although the efficacy and safety of benralizumab for patients with severe eosinophilic asthma are well established, the phase 3b ANDHI trial confirms and extend the efficacy profile of benralizumab for patients with severe eosinophilic asthma in terms of onset of clinical effect, disease-specific HRQOL data, patient and clinician perception of response and preliminary evidence on the effect of benralizumab for patients with nasal polyposis,” the authors said. “The results reinforce the exacerbation reduction benefit of benralizumab observed in the pivotal studies, particularly for patients with blood eosinophil counts of at least 300 cells per µL for whom exacerbation reduction versus placebo was 59%, similar to the 51% reduction observed for the primary analysis population of patients with at least 300 cells per µL in SIROCCO, and results seen in other patient populations.”