S900 Response Trajectory by the Clinical Decision Support Tool Probability Groups in Vedolizumab-Treated Patients With Crohn’s Disease: A Pooled Analysis of GEMINI 2, VISIBLE 2, and VERSIFY
Bibliographic record
Abstract
Introduction: Previously, a clinical decision support tool (CDST) has been developed to support treatment decisions in vedolizumab (VDZ)-treated patients (pts) with Crohn’s disease (CD).1 The patient reported outcome PRO2, comprising the sum of the Crohn’s disease activity index (CDAI) scores for stool frequency and abdominal pain, and quality of life (QoL) are treatment targets for pts with CD.2 We evaluated the PRO2 and QoL response according to the CDST probability groups. Methods: Pooled analysis of data from pts treated with VDZ in the 3 clinical trials GEMINI 2, VISIBLE 2 and VERSIFY. Based on STRIDE-II, symptomatic response was defined as decrease in PRO2 ≥50% from baseline, and symptomatic remission as an average daily stool frequency ≤3 and an average daily abdominal pain ≤1.2 Inflammatory Bowel Disease Questionnaire (IBDQ) remission was defined as total IBDQ score of ≥170. The analysis included only timepoints assessed in all 3 studies. Nonresponse imputation was applied on missing data. Results: A total of 1190 pts were included in this analysis and were categorized at baseline according to CDST as having a low (n=241), intermediate (n=548) or high (n=401) probability of response to VDZ. Mean (SD) PRO2 score decreased from baseline in all 3 CDST groups, with the high probability group showing the fastest and greatest change from baseline (Figure 1A). Symptomatic response at Week 6 was achieved by 162 (40.4%), 131 (23.9%), and 23 (9.5%) pts in the high, intermediate, and low CDST groups, respectively. The rates of symptomatic response in the high group continued to exceed those of the low and intermediate groups through Week 52. The rates of symptomatic remission were greater in the high probability group at Week 6 and continued to exceed those of the low and intermediate groups through Week 52 (Figure 1B). Mean (SD) IBDQ total score increased from baseline in all 3 CDST groups (Figure 1C). In the high probability CDST group, 26 (6.5%), 140 (41.7%), 185 (46.1%) and 167 (44.3%) pts, respectively, were in IBDQ remission at baseline, Week 6, Week 26/30 and Week 52. Conclusion: Based on patient reported outcomes, CDST is able to predict the probability of symptomatic response and remission with faster onset and higher rates observed in the high CDST group. Fast and greater improvement in QoL is also seen in the high CDST group. References 1. Dulai PS et al. (2018) Gastroenterology 155:687-695.e10. 2. Turner D et al. (2021) Gastroenterology 160(5):1570-1583.Figure 1.: Mean PRO2 score (A), symptomatic remission (B), and mean IBDQ total score (C) by CDST probability group. CDST, clinical decision support tool; IBDQ, inflammatory bowel disease questionnaire; PRO, patient reported outcome. Panels A and C show observed data, panel B shows results based on nonresponse imputed data. PRO2 is the sum of the stool frequency and abdominal pain score of the Crohn’s disease activity index.
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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 | 0.025 | 0.028 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.020 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".