DOP007 Change in Histological inflammation in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial
Bibliographic record
Abstract
Abstract Background Ulcerative colitis (UC) treatment targets include symptomatic, endoscopic, or histologic remission. The aim of the continuing VERDICT trial (NCT04259138) is to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early introduction of vedolizumab (VDZ). In this analysis, we report changes in histology indices: Nancy index (NI), Robarts Histopathological index (RHI) and Geboes score from baseline to weeks 16, 32 and 48 in patients for whom histologic remission was included as a treatment target. Methods Patients received VDZ 300 mg IV, as per a treatment algorithm related to baseline UC treatment, until assigned treatment target was reached, with escalation steps between week 16,32 and 48, as indicated. Treatment target groups were as follows: Group 1 (corticosteroid-free [CSF] symptomatic remission), Group 2 (CSF symptomatic remission + CSF endoscopic remission), and Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed disease clearance). CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo Endoscopic Score ≤1, and CSF histologic remission was defined as Geboes score<2B.0. For this analysis, we report the findings for Group 3, the only group with histologic remission included as a treatment target. Results At the interim data cutoff point for this analysis 672 patients were enrolled, with 265 patients in Group 3. Histologic scores improved by Week 16, with mean changes from baseline in NI of -1.4, and changes in RHI of -9.0. Histologic improvements continued to increase incrementally at Weeks 32 and 48 (Table). By Week 48, mean change from baseline in NI was -1.9 (Table). For RHI, mean change from baseline to Week 48 was -12.2. For both NI and RHI, mean change from baseline to Week 48 was greater in bionaïve than bio-exposed patients (Table). Histologic remission assessments were similar for NI, RHI, and Geboes score, with 50% of patients achieving corticosteroid-free histologic remission at Week 16, and 66.7% at Week 48 (Figure). Conclusion Vedolizumab treatment was associated with rates of corticosteroid-free histologic remission that were evident as early as Week 16 and increased incrementally through to Week 48, when it reached two thirds. The magnitude of histologic improvement was similar for all three scoring methods. References 1. Jairath et al., 2024. Doi:10.1136/bmjgast-2023-001218 2. Jairath et al., 2024. Doi: 10.1093/ecco-jcc/jjad212.0051 Funding The VERDICT trial is a collaborative study between Alimentiv and Takeda. Acknowledgements We thank the patients who participated in the trial, their caregivers, and the study investigators and members of the VERDICT study team. Medical writing support was provided by Paul Hassan, PhD, of Envision Pharma Group, and was funded by Takeda.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".