Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial
Bibliographic record
Abstract
BACKGROUND: Patients with moderately to severely active ulcerative colitis have distinct filgotinib response trajectories. AIMS: Evaluate factors associated with response to filgotinib over time. METHODS: Patients from SELECTION (NCT02914522) receiving filgotinib 200 mg (FIL200) or 100 mg (FIL100), or placebo were included. Factors associated with partial Mayo Clinic Score (pMCS) were assessed post hoc using a mixed model for repeated measures (MMRM). The prognostic value of week 10 faecal calprotectin (FCP) was assessed versus week 58 outcomes; p values are nominal. RESULTS: The MMRM included 558 patients (FIL200, n = 199; FIL100, n = 172; placebo, n = 187). For filgotinib, factors associated with lower week 58 pMCS versus respective comparators (p < 0.05) included being biologic-naive, low baseline inflammatory burden (endoscopic subscore <3, C-reactive protein ≤3 mg/L), or week 10 histological remission, endoscopic subscore ≤1, rectal bleeding and stool frequency subscores of 0, Inflammatory Bowel Disease Questionnaire scores >170, and/or lower FCP concentration. The optimal prognostic week 10 FCP cut-off for a concurrent week 10 Mayo Clinic Score response was <250 µg/g; combined week 10 FCP <250 µg/g and pMCS remission had similar week 58 prognostic value for clinical remission as week 10 endoscopic response. CONCLUSION: Being biologic-naive, having low baseline inflammatory burden, or strong week 10 filgotinib responses were associated with lower pMCS over 1 year of treatment. FCP <250 µg/g and week 10 pMCS remission may reduce the need for follow-up endoscopy.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".