304. DUPILUMAB IMPROVES INFLAMMATORY AND FIBROSTENOTIC FEATURES OF EOSINOPHILIC ESOPHAGITIS ON ENDOSCOPY: POOLED ANALYSIS FROM EOE KIDS AND LIBERTY EOE TREET
Bibliographic record
Abstract
Abstract Background Eosinophilic esophagitis (EoE) is a type 2 inflammatory disease with rising prevalence among children and adults. The American College of Gastroenterology EoE guidelines recommend systematic endoscopic assessment of the esophagus using EoE Endoscopic Reference Score (EREFS) at every endoscopy. Dupilumab, a fully humanized monoclonal antibody that blocks interleukin-4/−13, is approved for EoE in the USA and EU for patients aged ≥1 year, weighing ≥15 kg. Here, we assessed changes in EREFS in children, adolescents, and adults treated with dupilumab vs placebo from a pooled analysis of the phase 3 EoE KIDS (NCT04394351) and LIBERTY EoE TREET (NCT03633617) studies. Methods Patients from Part A of EoE KIDS randomized to weight-tiered, higher-exposure dupilumab or placebo for 16 weeks, and from Parts A/B of LIBERTY EoE TREET randomized to weekly dupilumab 300 mg or placebo for 24 weeks, were included. EREFS total scores (range: 0–9), inflammatory (0–5), and fibrostenotic subscores (0–4), were based on the worst observed region calculated using the highest (most severe) score for each feature from the proximal or distal esophagus (edema [0–1], rings [0–3], exudates [0–2], furrows [0–2], strictures [0–1]) at Week 16 or 24 (W16/24). P-values are nominal. Results The pooled cohort included 159 patients who received dupilumab and 152 who received placebo. Baseline characteristics were generally comparable between dupilumab and placebo groups for EREFS total score, inflammatory subscore, and fibrostenotic subscore (mean [standard deviation]: 4.0 [1.6] vs 4.1 [1.6]; 2.5 [1.0] vs 2.6 [0.9]; 1.6 [0.8] vs 1.6 [0.7], respectively). At W16/24, EREFS total score, inflammatory subscore, and fibrostenotic subscore were significantly reduced with dupilumab vs placebo (1.5 [1.3] vs 3.9 [1.8], P < 0.0001; 1.5 [0.6] vs 2.3 [1.0], P < 0.0001; 1.2 [0.5] vs 1.6 [0.7], P = 0.0009, respectively), as were scores for each feature (Figure). Conclusion In this pooled analysis of two phase 3 studies, patients with EoE treated with dupilumab demonstrated improvements in multiple endoscopic features (both inflammatory and fibrostenotic), as characterized by EREFS, at W16/24 vs placebo. Our findings are consistent with prior clinical trials suggesting that EREFS correlates with treatment response. Nevertheless, esophageal biopsies should be obtained from every endoscopy for EoE to assess for histologic features.
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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 | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.011 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| 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".