P712 Association of histologic-endoscopic mucosal healing after ustekinumab induction or maintenance therapy with 2-year outcomes in the UNIFI Phase 3 study in ulcerative colitis
Bibliographic record
Abstract
Abstract Background Ustekinumab (UST) is an effective therapy for moderate-to-severe ulcerative colitis (UC). Histological and endoscopic improvement of mucosa after induction are associated with clinical remission and steroid-free clinical remission at maintenance Week 44. The association of histological-endoscopic mucosal healing after UST induction or maintenance therapy with 2-year outcomes in moderate-to-severe UC is not known. Methods In the UNIFI study of UST in moderate-to-severe UC, histological-endoscopic mucosal healing was defined as achieving both endoscopic improvement (Mayo endoscopy subscore ≤1) and histological improvement (i.e., neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue; based on the Geboes score). Associations of mucosal improvement after induction (irrespective of treatment) or UST maintenance with long-term efficacy of UST, disease severity, inflammation level, and dose adjustment were evaluated up to Week 92 in the long-term extension (LTE) phase of UNIFI. Analysis was conducted in patients who were randomised to receive UST maintenance therapy and continued with UST in LTE. Tests with p-value <0.05 were considered statistically significant. Results Patients with histological-endoscopic mucosal healing after induction had significantly lower disease activity (partial Mayo score and stool frequency) and a trend for lower inflammation measured by CRP and faecal calprotectin at maintenance Week 44 than those without induction mucosal healing (Table 1). These improvements in disease activity were retained through LTE Week 92, with patients with induction histological-endoscopic mucosal healing showing a continuous reduction of disease activity. Significantly lower disease activity, CRP, and faecal calprotectin were also observed through LTE among patients with histological-endoscopic mucosal healing after UST maintenance compared with those without (Table 1). Patients with histological-endoscopic mucosal healing after induction remained on treatment longer than those without (p < 0.05). In addition, patients with histological-endoscopic mucosal healing after induction or maintenance were less likely to receive dose adjustment during LTE, but this association was not statistically significant. Conclusion Early macroscopic and microscopic improvement of the mucosa is an indicator of positive long-term clinical outcomes and reductions in inflammatory burden.
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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 | 0.009 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| 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".