Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naïve Patients With Early or Late Crohn’s Disease: Results From the EVOLVE Expansion Study
Bibliographic record
Abstract
Abstract Background We evaluated the real-world effectiveness and safety of vedolizumab and ustekinumab as first-line biologics in patients with Crohn’s disease (CD), by disease duration. Methods EVOLVE Expansion (ClinicalTrials.gov, NCT05056441) was a retrospective medical chart review study in Australia, Belgium, and Switzerland. Biologic-naïve patients with CD (≥18 years old) initiated first-line biologic treatment with vedolizumab or ustekinumab. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were assessed over 36 months. Outcomes were compared between patients with early (≤2 years) and late (>2 years) disease at biologic initiation. Serious adverse events (SAEs), serious infections (SIs), and healthcare resource use (HCRU) were evaluated. Results In early (n = 249) and late (n = 371) CD subgroups, there were no significant differences over 36 months between vedolizumab and ustekinumab in the cumulative rates of clinical response (early CD, 81.6% vs 80.7%; P = .31; late CD, 83.7% vs 86.5%; P = .31) or clinical remission (early CD, 87.9% vs 85.0%; P = .74; late CD, 91.1% vs 90.6%; P = .96). In patients with early CD, mucosal healing rates were significantly higher with vedolizumab than ustekinumab at both 24 (P = .02) and 36 months (P = .03). Treatment persistence was significantly higher with ustekinumab versus vedolizumab over 36 months in patients with late CD, but similar in patients with early CD. There were no significant differences in SAEs, SIs, or HCRU. Conclusions Both vedolizumab and ustekinumab are effective treatment options for early- and late-stage CD. Over 36 months, mucosal healing rates in patients with early CD were significantly higher with vedolizumab than with ustekinumab.
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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 | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".