Response to IL-5/IL-5R Antagonists and Remission Rate in Patients With Severe Asthma Who Would Have Been Excluded From the Pivotal Clinical Trials
Bibliographic record
Abstract
Background Randomized controlled trials (RCTs) assessing the efficacy of IL-5/IL-5R antagonists showed a significant reduction in asthma exacerbations as well as a corticosteroid-sparing effect in selected patients with severe eosinophilic asthma. Objective To compare the response and remission rate after treatment with IL-5/IL-5R antagonists in patients with asthma who would or would not have met inclusion criteria of pivotal RCTs. Methods This was a retrospective cohort study of patients with severe eosinophilic asthma aged 18 and older treated with IL-5/IL-5R antagonists between 2012 and 2020 in a tertiary outpatient asthma clinic. Patients aged 75 years or younger, with a smoking history of less than 10 pack-years and a reversible FEV 1 less than 80% predicted in the previous year were considered to fulfill the pivotal RCT inclusion criteria. Response to treatment and clinical remission of asthma were assessed in those who did or did not fulfill pivotal RCT inclusion criteria. Results A total of 108 subjects were included. Only 22 patients (20.4%) met all pivotal RCT inclusion criteria. There was no significant difference in response to treatment of these patients compared with those who did not fulfill inclusion criteria (odds ratio [95% CI] = 0.66 [0.15-2.85]). However, RCT eligibility was associated with a higher likelihood of achieving clinical remission (odds ratio [95% CI] = 4.09 [1.02-16.45]). Conclusion IL-5/IL-5R antagonists seem to be as effective in subjects who would have been excluded from pivotal RCTs as in those who met the RCT inclusion criteria, but RCT eligibility increases the likelihood of achieving clinical remission of asthma.
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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 | 0.006 | 0.007 |
| 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 | 0.002 |
| 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".