Effect of tezepelumab on exacerbation-related oral corticosteroid use 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 adults and adolescents with severe, uncontrolled asthma. Objective This pre-specified exploratory analysis evaluated the effect of tezepelumab on exacerbation-related oral corticosteroid (OCS) use in patients from NAVIGATOR. Methods NAVIGATOR was a multicentre, randomized, double-blind, placebo-controlled study. Patients (12–80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥1 additional controller medication with or without OCS were randomized 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The total number of days of exacerbation-related OCS use was assessed in the tezepelumab and placebo groups, and per patient in each group. In patients receiving maintenance OCS treatment, days with increased use were counted. Results Of 1061 randomized patients, 1059 received study treatment (tezepelumab 210 mg, n=528; placebo, n=531). Of these patients, 231 (44%) and 319 (60%) received OCS treatment for exacerbations during the treatment period in the tezepelumab and placebo groups, respectively. Over 52 weeks, the total number of days with exacerbation-related OCS use was 3706 and 8220 in the tezepelumab and placebo groups. The median (interquartile range) total number of days with exacerbation-related OCS use per patient was lower in the tezepelumab group (9 [5–16]) than the placebo group (14 [7–29]). Conclusion Patients with severe, uncontrolled asthma treated with tezepelumab had fewer days of OCS use for exacerbations than those who received placebo. 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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".