Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn’s Disease By Disease Location
Bibliographic record
Abstract
GOALS: This analysis compared the real-world effectiveness and safety of vedolizumab versus ustekinumab in biologic-naive patients by CD location. BACKGROUND: Crohn's disease (CD) location may affect disease course and treatment decisions. STUDY: Medical charts of biologic-naive patients with CD aged 18 years or older initiating vedolizumab or ustekinumab were analyzed in the multicenter, observational, retrospective EVOLVE Expansion study. Outcomes with vedolizumab versus ustekinumab over 36 months were compared in patients with baseline isolated ileal, ileocolonic, and isolated colonic CD (Montreal classification). RESULTS: This analysis included 293 patients with ileal (vedolizumab, n=158, ustekinumab, n=135), 185 with ileocolonic (vedolizumab, n=91, ustekinumab, n=94), and 121 with colonic (vedolizumab, n=84, ustekinumab, n=37) CD. Cumulative rates over 36 months were similar between vedolizumab and ustekinumab in ileal, ileocolonic, and colonic CD subgroups for clinical response, remission, mucosal healing, and treatment persistence. There were no differences in risks of serious adverse events, serious infections, CD exacerbations, and CD-related hospitalizations between cohorts across disease location; the risk of CD-related surgeries was similar in patients with ileocolonic and colonic CD, and higher with vedolizumab versus ustekinumab in patients with ileal CD. CD-related surgeries for ileal CD were reported in 12 of 158 (7.6%) vedolizumab-treated patients and 3 of 135 (2.2%) ustekinumab-treated patients. CONCLUSIONS: Effectiveness, safety, and health care resource utilization outcomes over 36 months were similar between treatment cohorts regardless of baseline disease location. The number of patients requiring CD-related surgeries was low. Both vedolizumab and ustekinumab can be used as first-line biologics in patients with CD, regardless of disease location.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".