S1815 Early Response to Vedolizumab in Patients With Crohn's Disease in a Prospective Observational Study in Canada and US: The VOICE Study
Bibliographic record
Abstract
Introduction: VOICE (NCT06249555) is a prospective, observational study in adult (≥18 yrs) pts with Crohn’s disease (CD) in Canada and the United States initiating vedolizumab (VDZ) treatment (tx) as part of standard care. The aim is to explore the response to VDZ measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) scores in the following domains: pain interference, fatigue, anxiety, depression, physical function, sleep disturbance, and ability to participate in social roles or activities. Methods: Inclusion criteria include baseline PROMIS Pain Interference (PI)-SF T-score ≥55 (0.5 SD above general population). The primary endpoint is time to first meaningful clinical improvement in PROMIS PI-SF T-score (≥2-point decrease from baseline). Other endpoints include: improvement in 7 PROMIS domains (5-point (0.5 SD) change in T-score from baseline); Short Inflammatory Bowel Disease Questionnaire (SIBDQ) improvement (≥9 point increase from baseline) and remission (score of ≥60); and safety. Here, we report results from pts with ≥1 VDZ dose and ≥1 post-baseline PI assessment included in an interim analysis (IA; prespecified to occur after 50 pts completed or discontinued before wk 14). Results: Overall, 64 pts with ≥1 VDZ dose and ≥1 post-baseline PROMIS PI assessment (mean ± SD age, 43.1 ± 17.0 years, 35.9% male, 92.2% White) were included in the IA. Disease duration (mean ± SD) was 6.4 ± 12.1 years; 84.4% of pts were anti-TNF-naïve. Baseline PROMIS domain scores indicated notable impairment. By wk 14, improvements from baseline were observed in all 7 measured domains, with ≥5-point improvements in 4/7 domains. The median time to achieve the first ≥2-point decrease in PROMIS PI-SF T-score (n = 56/64 pts) was 12 days (95% CI, 6-13). At wk 14, 37.5% (24/64) and 7.8% (5/64) pts achieved SIBDQ improvement and remission, respectively. One pt had serious adverse events of appendicitis and diverticulitis, and another pt had a fatal event; none were related to VDZ tx. Conclusion: This IA shows an early improvement across multiple symptom domains and in pts with CD starting VDZ tx. Time to first ≥2-point decrease in PROMIS PI-SF T-score was short, with a benefit observed after 12 days from VDZ initiation. Study recruitment with a planned sample size of 200 VDZ patients and a comparator group of 100 anti-IL-23 pts) and data collection are ongoing.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| 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".