| Abstrakt: |
Introduction and ObjectivesBenralizumab, a humanised anti-eosinophil monoclonal antibody, is in development as an add-on treatment for severe, uncontrolled, eosinophilic asthma. During Phase III trials, benralizumab significantly reduced annual asthma exacerbation rates and was well-tolerated.1,2The GREGALE study (NCT02417961) assessed patient and caregiver-reported functionality, performance, and reliability of an accessorised pre-filled syringe (APFS) used to administer benralizumab subcutaneously in an at-home setting.MethodsPatients (n=116) with severe, uncontrolled asthma despite receiving medium- or high-dosage inhaled corticosteroids and long-acting β2-agonists, received up to five APFS-administered subcutaneous doses (Weeks 0, 4, 8, 12, and 16) of 30 mg benralizumab. The first three doses were administered at the study sites. The patient/caregiver administered the last two doses at home. Endpoints included the percentage of patients/caregivers who successfully administered benralizumab at home, percentage of APFS returned to study sites and evaluated as functional, percentage of APFS returned as malfunctioning to Product Complaints, efficacy (Asthma Control Questionnaire 6 [ACQ-6]), safety, and pharmacodynamics (blood eosinophil count).ResultsNearly all patients and caregivers successfully administered benralizumab with an APFS at home (Week 12: 112/114, 98%; Week 16: 108/109, 99%; figure 1). Two at-home administrations were unsuccessful because of patient-use error. One APFS was recorded as nonfunctional because it was not returned for evaluation. Product Complaints identified only 1 APFS malfunction of 573 dispensed. Mean ACQ-6 scores decreased from baseline through all postbaseline time points through end of treatment (baseline: mean 2.14 [standard deviation {SD} 0.81]; Week 20: mean 1.40 [SD 0.90]). Near-complete depletion of eosinophils was observed at end of treatment vs. baseline (baseline: median 250 cells/µL [interquartile range {IQR} 175–430 cells/µL]; and Week 20: median 0 cells/µL [IQR 0–10 cells/µL]). Incidence of adverse events leading to benralizumab discontinuation was 2.6%. Most common adverse events (≥5% of patients) were nasopharyngitis, upper respiratory tract infection, headache, and sinusitis. Five patients (4.3%) experienced transient mild or moderate injection-site reactions.[Figure]ConclusionsMost patients and caregivers successfully administered benralizumab in an at-home setting. The APFS was functional, reliable, and performed well.Please refer to page A258 for declarations of interest in relation to abstract P69.ReferencesBleecker ERet al. Lancet2016;388:2115–27.FitzGerald JMet al. Lancet2016;388:2128–41. |
