S0887 Fecal Calprotectin as a Surrogate Marker of Clinical Remission, Clinical Response, Endoscopic Improvement, and Histo-Endoscopic Mucosal Healing: UNIFI Induction Study
Bibliographic record
Abstract
INTRODUCTION: Previously we reported the safety and efficacy of ustekinumab (UST) therapy for the treatment of moderately to severely active UC patients in the Phase 3 UNIFI studies.1 The objective of these analyses was to assess, using data from the UNIFI induction study,1 the operating properties of fecal calprotectin (FCP) with clinical remission, clinical response, endoscopic improvement, and histo-endoscopic mucosal healing (HEMH) as endpoints. METHODS: The UNIFI induction study was a multicenter, randomized, placebo- (PBO) controlled trial that randomized patients to intravenous dosing with PBO, UST 130 mg and UST ∼6 mg/kg.1 FCP was measured at Weeks (W) 0 (baseline), 2, 4 and 8 using the CALPRO® Calprotectin ELISA Test. The area under the Receiver Operating Characteristic curve (AUC-ROC) was used to assess the accuracy of absolute change and percent (%) change from baseline in FCP at W4 for prediction of clinical response, clinical remission, endoscopic improvement, and HEMH at W8 for UST 6 mg/kg-treated patients, (the FDA approved induction dosage). Sensitivity, specificity, and negative and positive likelihood ratios of cut-off % change in FCP from baseline at W4 were also estimated for the W8 outcomes. RESULTS: AUC-ROC analyses demonstrated % change from baseline in FCP at W4 predicted efficacy outcomes at W8 more accurately than the corresponding absolute change from baseline at W4: HEMH (0.70 vs 0.58), clinical remission (0.65 vs 0.54), endoscopic improvement (0.64 vs 0.58), and clinical response (0.60 vs 0.58), respectively. The % change from baseline in FCP at W4 had the best accuracy in predicting W8 HEMH compared with its diagnostic accuracy in predicting clinical remission, endoscopic improvement, and clinical response at W8. Sensitivity, specificity, and negative and positive likelihood ratios for 50% and 80% change from baseline in FCP at W4 in predicting efficacy outcomes at W8 are shown in (Table 1). Conclusion: Overall, these data suggest that early improvements in FCP may be used as a surrogate marker of clinical outcomes after intravenous induction of UST in UC patients.Table 1
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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 | 0.008 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".