P69 Functionality, reliability, and performance of an accessorised pre-filled syringe with home-administered subcutaneous benralizumab for adult patients with severe asthma
Bibliographic record
Abstract
Introduction and Objectives Benralizumab, 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.1,2 The 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. Methods Patients (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). Results Nearly 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. Conclusions Most 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. References Bleecker ERet al. Lancet2016;388:2115–27. FitzGerald JMet al. Lancet2016;388:2128–41.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".