Add-on mepolizumab for chronic rhinosinusitis with nasal polyps: SYNAPSE study
Bibliographic record
Abstract
Prof. Martin Wagenmann MD is presenting the data on behalf of all the authors with their permissions. The abstract was previously presented at ERS2020, Eur Respir J. 2020;56(Suppl. 64):4616. Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory disease with recalcitrant symptoms. NP tissue eosinophils lead to recurrence, which often require repeat surgeries. Aims: To assess the efficacy and safety of 4-weekly add-on mepolizumab 100 mg SC in adults with CRSwNP. Methods: SYNAPSE (NCT03085797), a randomised, double-blind, placebo-controlled, multicentre, 52-week study, included patients with severe bilateral NP, treated with intranasal corticosteroids; with a prior NP surgery and eligible for repeat surgery. Co-primary endpoints: changes in total endoscopic NP score (Week 52) and nasal obstruction VAS score (Weeks 49 – 52). Secondary endpoints: time to first NP surgery (key); overall VAS symptom score, Sinonasal Outcome Test-22 score; systemic corticosteroid (SCS) use, composite and loss of smell VAS scores. Safety was assessed. Results: Total endoscopic NP score and nasal obstruction VAS score significantly improved (p < 0.001) with mepolizumab (n = 206) vs. placebo (n = 201). Median change in endoscopic NP score showed a 1-point improvement with mepolizumab (adjusted: − 0.73 [95% CI:-1.11,-0.34]); median change in nasal obstruction VAS score showed a > 3-point improvement (adjusted: − 3.14 [− 4.09,-2.18]). All secondary endpoints significant. Mepolizumab reduced NP surgery by 57% (hazard ratio 0.43 [0.25,0.76]; p = 0.003), improved SNOT-22, VAS (overall, composite, loss of smell) and SCS use. No new safety issues with mepolizumab. Nasopharyngitis was the most common AE (23 – 25%). Conclusions: Mepolizumab improved NP size and sinonasal symptoms and reduced NP surgery and SCS use in adults with severe CRSwNP and may be a treatment option in this population. Publication History Article published online: 30 April 2021 © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG 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) | 0.001 | 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".