Use of Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease Endoscopic Improvement Thresholds Enhances Effect Size Differentiation Between Adalimumab Versus Placebo: A Post Hoc Analysis of the EXTEND Trial
Bibliographic record
Abstract
INTRODUCTION: The Modified Multiplier of the Simple Endoscopic Score for Crohn's Disease (MM-SES-CD) refines the assessment of endoscopic CD severity by differentially weighting parameters in the original SES-CD. A threshold of <22.5 for MM-SES-CD suggests endoscopic remission (ER) and correlates with a low risk of long-term disease progression. This study examines whether MM-SES-CD-defined ER and response criteria are more sensitive to treatment effects compared to conventional SES-CD definitions. METHODS: This post hoc analysis of the EXTEND (extend the safety and efficacy of adalimumab through endoscopic healing) trial compared various SES-CD and MM-SES-CD definitions of ER and endoscopic response in CD patients treated with adalimumab or placebo. The study included participants with moderate-severe CD and a baseline MM-SES-CD score ≥ 22.5. The primary outcome of ER, defined as MM-SES-CD < 22.5, was evaluated at Weeks 12 and 52. Area under the curve (AUC) analyses compared thresholds for predicting Week 52 ER. RESULTS: Of the 100 participants (77.5% of the EXTEND population), 51 received adalimumab and 49 received placebo. At Week 12, 62% achieved MM-SES-CD ≥ 20% reduction from baseline, compared to 39% with SES-CD ≥ 50% reduction. At Week 52, 56.9% of adalimumab-treated participants achieved MM-SES-CD < 22.5, compared to 10.2% in the placebo group. Modified Multiplier of the Simple Endoscopic Score for Crohn's Disease ≥ 20% reduction at Week 12 better predicted Week 52 ER than SES-CD ≥ 50% reduction (AUC: 0.73 vs 0.62, p = 0.002). CONCLUSION: MM-SES-CD definitions improved discrimination between treatment and placebo and offered superior predictive accuracy for Week 52 ER. Its use may enhance trial efficiency and better predict long-term disease outcomes.
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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 | 0.030 | 0.028 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.006 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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".