Results of ANDHI provide additional support on the safety and efficacy of benralizumab for patients with asthma.
Recent study findings further back the efficacy and safety of benralizumab for patients with severe asthma.
Tim Harrison, MBBS, BSc, FRCP, MD, MSc, from the Respiratory Research Unit at the University of Nottingham, and colleagues conducted the ANDHI trial to extend knowledge and understanding of the efficacy and safety of benralizumab for severe eosinophilic asthma patients, including the onset of effect and additional health-related quality of life measures. They included adult patients with severe eosinophilic asthma with at least 2 prior-year exacerbations despite high-dosage inhaled corticosteroid plus additional controllers and screening blood eosinophil counts of at least 150 cells/µL.
Patients were randomized 2:1 to either 24 weeks of benralizumab 30 mg every 8 weeks or placebo. Those who had blood eosinophil counts of at least 150 to less than 300 cells/µL were required to have at least 1 of the following: maintenance oral corticosteroids use, nasal polyposis, forced vital capacity less than 65% predicted, at least 3 prior-year exacerbations, or at least 18 years old at diagnosis.
Additional variables taken into account included annualized asthma exacerbation rate and change from baseline to week 24 in St. George’s Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 second (FEV1), and Asthma Control Questionnaire 6 (ACQ-6). Further, the team analyzed the results of the Sino-Nasal Outcome Test-22 (SNOT-22) in a subset of patients with a history of nasal polyposis.
Harrison and the team randomized 656 patients to receive either benralizumab (n=427) or placebo (n=229). Characteristics and demographics were similar in the benralizumab versus placebo groups (female, 61.6% vs 59.4%; mean age, 52.5 vs 53.3 years old; white, 86% vs 85.7%; prior year asthma exacerbation rate, 3.2 vs 3.1; mean pre-bronchodilator FEV1, 1700 vs 1750 mL; mean SGRQ total score, 58.19 vs 56.69; Phadiatop positive, 56.5% vs 57.6%). Both groups had a median baseline eosinophil count of 390 cells/µL.
Nasal polyposis was present for 34.2% of those in the benralizumab group and 35.8% of placebo patients, with a mean SNOT-22 of 51.5 for benralizumab versus 48.2 for placebo. The team found benralizumab significantly improved asthma exacerbation rate, with a 49% reduction versus placebo (.94 vs 1.86; P <.0001). There was also a clinically meaningful and statistically significant improvement in least-squares mean change in SGRQ total score at week 24 versus placebo (delta-8.11; P <.0001), with similar differences at earlier times throughout the study period. Benralizumab improved lung function, ACQ-6, and SNOT-22 at week 24 versus placebo.
The investigators noted the safety between both treatment groups was similar, with adverse events reports slightly more for benralizumab patients (63.5%) compared to placebo (62.4%). Commonly reported adverse events included headache, nasopharyngitis, sinusitis, pyrexia, and bronchitis. Less patients in the benralizumab group reported serious adverse events (5.4% vs 10.9%).
“ANDHI results extend benralizumab’s efficacy and safety profile for severe asthma patients, including differences observed at first time point in lung function and diseasespecific (health-related quality of life), effects on (nasal polyposis), and safety comparable with previous studies,” Harrison and the team concluded.
The study, “Exacerbation Reduction and Early and Sustained Improvements in SGRQ, Lung Function, and Symptoms of Nasal Polyposis with Benralizumab for Severe, Eosinophilic Asthma: Phase IIIb ANDHI Trial,” was presented as part of the American Thoracic Society annual meeting.