OP08 Mucosal healing with vedolizumab in inflammatory bowel disease patients with chronic pouchitis: Evidence from EARNEST, a randomized, double-blind, placebo-controlled trial
Bibliographic record
Abstract
Abstract Background Mucosal healing (MH) is an important treatment goal for inflammatory bowel disease (IBD). Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking agent, has shown potential to achieve MH.1,2 EARNEST, a randomized double-blind placebo-controlled trial of VDZ in chronic pouchitis,3 offers a robust dataset systematically collected from the inflamed pouch mucosa to further explore the impact of VDZ treatment on MH. Methods EARNEST evaluated intravenous VDZ (300 mg) vs placebo (PBO) administered at weeks 0, 2, 6, 14, 22, and 30, in adult patients (pts) with active chronic pouchitis despite antibiotic therapy after proctocolectomy and ileal pouch-anal anastomosis for ulcerative colitis. Endoscopic imaging was captured and centrally read at baseline, Week (W) 14, and W34. Total ulceration and SES-CD (modified to apply to a single segment) were evaluated. Microscopic inflammation was also evaluated using the Pouchitis Disease Activity Index (PDAI) histological component. Pre-specified exploratory endpoints included changes in total ulceration and SES-CD remission (score ≤2); MH was defined post-hoc as SES-CD=0 plus PDAI histology score ≤1 (none/mild polymorphic nuclear leukocyte infiltration and no ulceration). Fecal calprotectin (FCP) levels were explored by MH status. PDAI remission (score <7 and ≥3 point-reduction from baseline) and Inflammatory Bowel Disease Questionnaire (IBDQ) remission (score ≥170) were assessed in pts with/without MH at W14. Results In total, 98 pts had endoscopic evaluations (VDZ n=48; PBO n=50). Ulcers/erosions were higher in VDZ pts at baseline with a greater reduction at W14 and W34 with VDZ vs PBO (Table 1). More pts treated with VDZ vs PBO achieved reduction in ulcerated surface area, complete absence of ulceration/erosions and SES-CD remission. At W14, 7/42 (16.7%) pts had MH on VDZ vs 1/40 (2.5%) on PBO. All 7 VDZ pts with MH at W14 were in PDAI remission at W14 and W34; 6/7 (85.7%) pts achieved IBDQ remission at W14 and 5/7 (71.4%) achieved IBDQ remission at both W14 and W34. Of the 35 VDZ-treated pts without MH at W14, 11/35 (31.4%) achieved PDAI remission at W14, 11/35 (31.4%) at W34, and 9/35 (25.7%) at both W14 and W34; 13/35 (37.1%) achieved IBDQ remission at W14, 17/35 (48.6%) at W34, and 12/35 (34.3%) at both W14 and W34. MH was associated with FCP ≤250 µg/g while ~40-60% of pts without MH had FCP >250 µg/g (Table 2). Conclusion VDZ was associated with better control of markers of inflammation vs PBO, based upon improvements in endoscopic/histologic outcomes in the pouch mucosa, as well as improved outcomes reported by pts. These effects of VDZ in the pouch mucosa are consistent with those observed in the wider patient population with IBD.
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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 | 0.004 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 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".