Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR
Bibliographic record
Abstract
Background Tezepelumab is a human monoclonal antibody that blocks activity of thymic stromal lymphopoietin. The phase 3 NAVIGATOR study (NCT03347279) investigated tezepelumab’s efficacy and safety in patients with severe, uncontrolled asthma. Objective This pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with or without reported nasal polyps (NP+ or NP−) in the past 2 years. Methods NAVIGATOR was a multicentre, randomized, double-blind, placebo-controlled study. Patients (12–80 years old) were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The annualized asthma exacerbation rate (AAER) over 52 weeks and the least-squares (LS) mean changes from baseline to week 52 in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV 1 ) and Sino-Nasal Outcomes Test (SNOT)-22 score were assessed in NP subgroups. Results Of 1059 patients (tezepelumab, n=528; placebo, n=531), 83 had NP in the past 2 years and 976 did not. Mean (SD) baseline pre-BD FEV 1 (tezepelumab, placebo) was 2.01 (0.75) L and 1.89 (0.66) L for NP+ patients and 1.82 (0.71) L and 1.85 (0.71) L for NP− patients. Tezepelumab reduced AAER by 86% (95% CI: 70–93) and 52% (95% CI: 42–61), and improved pre-BD FEV 1 by 0.20 L (95% CI: 0.02–0.37) and 0.13 L (95% CI: 0.08–0.18) versus placebo in NP+ and NP− patients, respectively. Tezepelumab reduced SNOT-22 score in NP+ patients by 9.6 points (95% CI: 0.9–18.2) versus placebo (baseline mean scores: tezepelumab, 49.4; placebo, 47.8). Conclusion Tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid NP. Acknowledgements Medical writing support was provided by Madeleine Wynn, MRes, of PharmaGenesis London, London, UK, with funding from AstraZeneca and Amgen Inc. Publication History Article published online: 11 May 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".