Background and objective The phase IV Fasenra Safety Trial in India (FAST) assessed the safety and effectiveness of benralizumab for a period of 24 weeks in adult Indian patients with severe eosinophilic asthma. Methods This phase IV, single-arm, multicenter, prospective, interventional study (NCT05384938) included benralizumab-naïve adult patients (18–75 years) with a physician-confirmed diagnosis of severe asthma with an eosinophilic phenotype. Patients received 30 mg of benralizumab subcutaneously once every 4 weeks for the first three doses and then 30 mg once every 8 weeks thereafter as part of routine clinical care. The primary outcomes included adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious TEAEs, along with the nature, incidence, and severity of AEs, including unexpected adverse drug reactions and AEs leading to treatment discontinuation or dose modifications. The secondary outcomes included time to first asthma exacerbation, annualized exacerbation rate, treatment outcome, and changes in absolute eosinophil count. Results Of the 155 patients screened, 138 (89.0%) who received at least one dose of benralizumab were included in the safety and effectiveness analysis. At baseline, the median number of asthma exacerbation events per year was 2.0, and the median absolute eosinophil count was 375.0 cells/mm 3 (range: 70.0–7352.8). Overall, 31.2% of the patients (43) experienced TEAEs; the most common TEAEs were pyrexia (16.7%), dyspnea (5.1%), productive cough (4.4%), cough (2.9%), and nasopharyngitis (2.2%). Serious TEAEs were reported in 5 (3.6%) patients and included dyspnea and productive cough (reported in 4 patients each), pyrexia (3), and constipation, H1N1 influenza, and back pain (1 each). No TEAEs leading to study drug discontinuation or death were reported. Nineteen (13.8%) patients experienced asthma exacerbation during the 24 weeks, with a median (range) time to first exacerbation event of 100.0 (41–184) days. A total of 61.5% of the patients (83/135) had well-controlled asthma, while 33.3% (45/135) had partly controlled asthma. A statistically significant decrease was observed in the mean asthma exacerbation events per year (from baseline to Week 24; 2.0 vs. 0; p 0.0001) and peripheral blood eosinophil counts (from baseline to Weeks 4, 16, and 24; p 0.001). Conclusion The findings of this prospective, single-arm, multicenter, phase IV study in Indian patients with severe eosinophilic asthma demonstrated that benralizumab showed an acceptable and expected safety profile with consistent efficacy. Clinical trial registration https://clinicaltrials.gov/study/NCT05384938 , identifier NCT05384938.
Talwar et al. (Mon,) studied this question.