Late Breaking Abstract - Long-term safety and efficacy of benralizumab in severe, uncontrolled asthma: first results of BORA, a randomized, Phase III extension study
Bibliographic record
Abstract
Introduction: Patients (pts) who completed Phase III SIROCCO, CALIMA, and ZONDA trials, which demonstrated the efficacy and safety of benralizumab in severe, uncontrolled asthma, could participate in the safety extension study BORA (NCT02258542). Aims and Objectives: We evaluated the safety and efficacy for pts who received 1 year of benralizumab in BORA. Methods: Pts exiting predecessor studies on benralizumab 30 mg SC every 4 weeks (Q4W) or every 8 weeks (Q8W) continued their regimens in BORA. Predecessor placebo (p-pbo) pts were re-randomized 1:1 to either Q4W or Q8W. Primary outcome was safety. Secondary outcomes included annual asthma exacerbation rate (AER) and prebronchodilator FEV1. This analysis presents pts who completed SIROCCO/CALIMA (~1 year) and received benralizumab Q8W for 1 year in BORA. Results: 793 pts (predecessor Q8W [p-Q8W] 512; p-pbo 281) were included. Safety profile was consistent with previous studies (table). ~75% of pts remained exacerbation-free with benralizumab Q8W, with AERs similar to SIROCCO/CALIMA results. FEV1 improved in p-pbo pts and was maintained in p-Q8W pts at Week 56 vs. baseline (median [min, max] 0.050 L [−1.23, 1.42] and 0.00 L [−0.85, 1.69], respectively). Conclusions: Safety and efficacy profiles in Year 2 of benralizumab treatment were consistent with predecessor studies. ~75% of pts on benralizumab remained exacerbation‑free.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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".