P185 A comparison of early response parameters to inform a treat-to-target approach in ulcerative colitis
Bibliographic record
Abstract
Abstract Background We aimed to evaluate early markers of response after vedolizumab (VDZ) induction therapy for their prognostic value in determining the long-term risk of colectomy. Methods Post hoc analysis of VDZ-treated patients (n = 588) enrolled in the GEMINI 1 and long-term safety (LTS) clinical trial programs. Rates of colectomy during the 7-year follow-up period were compared according to treatment response status at week 6 (induction) for various definitions of Clinical remission [CR] (rectal bleeding sub-score [RBS] 0 + stool frequency sub-score [SFS] ≤1), Biomarker remission [BR] (faecal calprotectin [FC] ≤50, ≤100, ≤250), or endoscopic improvement [EI] (Mayo endoscopic sub-score [MES] ≤1) and endoscopic remission [ER] (MES 0). Time-to-event with log-rank and Cox proportional hazard analyses were used and presented as hazard ratios (HR) with 95% confidence intervals (CIs). Results The risk of colectomy was comparable between UC patients achieving week 6 CR vs. those with persistent symptoms (HR 0.74, 95% CI 0.37–1.48, p = 0.39). The risk of colectomy trended lower in patients achieving week 6 EI (HR 0.55, 95% CI 0.28–1.10, p = 0.08), but was comparable between those achieving an MES of 1 vs. 0 (HR 1.45, 95% CI 0.39–5.48, p = 0.58). The risk of colectomy was significantly lower in patients achieving week 6 BR using an FC cut-off of 250 (HR 0.30, 95% CI 0.13–0.68, p = 0.002) and 100 (HR 0.18, 95% CI 0.04–0.73, p = 0.007) but not with a cut-off of 50 (HR 0.34, 95% CI 0.08–1.41, p = 0.12). The proportion of patients requiring colectomy over a 7-year period was lower among those achieving week 6 BR (FC 250, 3.3%; FC 100, 1.8%) compared with patients who achieved week 6 EI (5.6%), although over one-third of patients who achieved week 6 BR had moderate–severe endoscopic activity (MES 2–3) at week 6. Conclusion FC as an early biomarker of response at week 6 may aid in identifying patients who remain at low risk of future colectomy, despite having persistent symptomatic or endoscopic activity. These findings may be limited by overall low rates of colectomy in GEMINI LTS, but can inform considerations for early treat to target approaches.
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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 | 0.013 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| 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".