When compared to placebo, benralizumab results in a significantly improved asthma exacerbation rates.
Tim Harrison, MBBS, BSc, FRCP, MD, MSc
There is currently a knowledge gap in regard to the efficacy and safety of benralizumab for patients with severe eosinophilic asthma, including the onset effect and additional health-related quality of life measures.
A team, led by Tim Harrison, MBBS, BSc, FRCP, MD, MSc Respiratory Research Unit, Nottingham NIHR BRC, University of Nottingham, planned to present findings on the 656 ANDHI patient study at the American Thoracic Society (ATS) 2020 International Conference.
In the study, the investigators examined adults with severe, eosinophilic asthma with ≥2 prior-year exacerbations despite high-dosage inhaled corticosteroid [ICS] plus additional controller[s] and screening blood eosinophil counts [BEC] ≥150 cells/µL.
Each patient was randomized in a 2:1 ratio of either 24 weeks of benralizumab (30 mg every 8 weeks [first 3 doses every 4 weeks]) (n = 427) or placebo (n = 229).
The demographics for both treatment groups were similar (female = 61.6% vs 59.4%; mean age = 52.5 vs. 53.3 years; white = 86.0% vs 85.7%; prior year asthma exacerbation rate [AER] = 3.2 vs. 3.1; mean pre-BD FEV1 = 1700 vs 1750 mL; mean SGRQ total score = 58.19 vs. 56.69; Phadiatop positive = 56.5% vs 57.6% [benralizumab vs. placebo, respectively]).
In addition, patients in the BEC ≥150-<300 cells/µL group were required to have ≥1 of maintenance oral corticosteroids (OCS) use, nasal polyposis (NP), FVC<65% predicted, ≥3 prior-year exacerbations, or aged ≥18 years at diagnosis.
The investigators sought primary and secondary efficacy variables of annualized asthma exacerbation rate and change from baseline to week 24 in the St. George’s Respiratory Questionnaire (SGRQ) total score, FEV1, and Asthma Control Questionnaire 6 (ACQ-6).
They also used the Sino-Nasal Outcome Test-22 (SNOT-22) for a subset of patients with a medical history of nasal polyposis.
The median baseline eosinophil count was 90 cells/µL for both groups and nasal polyposis was reported for 146 (34.2%) benralizumab and 82 (35.8%) placebo patients. There was also a mean SNOT-22 of 51.5 for the benralizumab treatment group and 48.2 for placebo.
Ultimately, the treatment substantially improved AER, with a 49% reduction when compared to placebo (0.94 vs. 1.86; P ≤.0001). The investigators also found a clinically meaningful and statistically significant improvement in the least-squares mean change in SGRQ total score at week 24 compared to placebo (∆−8.11; P ≤.0001), with similar differences at all earlier time points.
The treatment also improved lung function, ACQ-6, and SNOT-22 scores at week 24 compared to placebo, with numerical or statistical differences observed from the first measured time points.
There was also no major differences in safety between the 2 groups, with adverse events reported for 63.5% of benralizumab patients and 62.4% of placebo patients, including headaches, nasopharyngitis, sinusitis, pyrexia, and bronchitis.
There were fewer serious adverse events found in the benralizumab group (5.4%) when compared to the placebo (10.9%) group.
“ANDHI results extend benralizumab’s efficacy and safety profile for severe asthma patients, including differences observed at first time point in lung function and disease-specific HRQOL, effects on NP, and safety comparable with previous studies,” investigators wrote.
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 published online by the ATS International Conference.