Histologic Predictors of Endoscopic Healing in Crohn's Disease
Bibliographic record
Abstract
Crohn's disease (CD) is an inflammatory bowel disease that can affect any part of the gastrointestinal tract and is characterized by periods of relapse and remission. Unfortunately, patients with CD often experience disease progression, including fistulas, strictures, and symptoms including worsening abdominal pain and/or diarrhea.(1) The Crohn’s Disease Activity Index (CDAI) is a widely used tool in clinical trials for CD as primary endpoints, namely clinical remission (CR) and response.(2,3) While the CDAI has demonstrated drug efficacy through these endpoints, histologic endpoints are lacking. Several studies have identified a disconnect between patient reported symptoms and endoscopic evidence of disease, which may be attributed to the presence of comorbid gastrointestinal disorders. Treatment goals have evolved to include endoscopic-based endpoints, using tools such as the Crohn’s Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for CD (SES-CD).(4,5) However, evidence of histologic inflammation is present in approximately one third of patients achieving endoscopic healing.(6,7) Therefore, the relationship between clinical, histologic and endoscopic measures of CD activity require further investigation. The Global Histology Activity Score (GHAS) is a widely used tool that grades biopsies of the ileum and colonic segments (collected at baseline, week 12 and 54 in EXTEND).(8) Therefore, regional and global GHAS can be separated and compared. Recently, the efficacy of ustekinumab on histologic improvement in CD patients have been explored, using data from the phase 3 induction and maintenance UNITI trials (ClinicalTrials.gov NCT01369329, NCT01369342, and NCT01369355) (9). However, to date, no study has investigated the relationship between baseline histologic disease activity and ability to attain endoscopic healing in CD. The primary objective of this study is to evaluate the association between baseline histologic characteristics and endoscopic measures of disease activity at week 54 using data from the EXTEND trial. The secondary objectives of this study include assessing alternative definitions of mucosal healing (SES-CD of 0 and/or absence of mucosal ulcerations) and endoscopic response (SES-CD reduction at least 50% from baseline) at week 12 and 54. Planned exploratory analyses with immunohistochemistry may be done. Logistic regression will be used and models will be adjusted for confounders, such as disease duration, treatment allocation, concomitant corticosteroid use and concomitant immunomodulator use.
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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 | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".