Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis
Bibliographic record
Abstract
BACKGROUND: Eosinophilic esophagitis (EoE) is a chronic type 2 inflammatory esophageal disease driven by interleukin 13 (IL-13). Cendakimab, a high-affinity monoclonal antibody, binds IL-13, blocking interaction with receptors IL-13 receptor alpha 1 and IL-13 receptor alpha 2. METHODS: In this phase 3 trial, we randomly assigned patients with EoE 12 to 75 years of age to cendakimab 360 mg once weekly for 48 weeks (QW/QW), cendakimab 360 mg once weekly (QW) for 24 weeks, then 360 mg every other week for weeks 24 to 48 (QW/Q2W), or placebo for 48 weeks. Coprimary end points at week 24 were change from baseline in dysphagia days, measured by a validated patient-reported modified Daily Symptom Diary, and histologic response (peak esophageal eosinophil count ≤6 per high-power field). Secondary end points included endoscopic features and safety. Cendakimab QW/QW and QW/Q2W regimens were assessed as a single treatment group in the analyses from week 0 to week 24 (cendakimab QW) and as separate treatment groups versus placebo in the analyses from weeks 24 to 48. RESULTS: <0.001). Cendakimab improved endoscopic severity from baseline to week 24, compared with placebo (least-squares mean change [standard error] -5.2 [0.24] points vs. -1.2 [0.34] points). Efficacy was maintained at week 48. Adverse events occurred in 83.8%, QW/QW, and 84.6%, QW/Q2W, of patients with cendakimab and 73.4% with placebo through week 48. CONCLUSIONS: Cendakimab demonstrated statistically significant improvements in symptoms, histologic response, and endoscopic features of EoE versus placebo; the adverse-event and side-effect profile was not dose limiting. (Funded by Bristol Myers Squibb; ClinicalTrials.gov number, NCT04753697.).
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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 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".