Effectiveness of Ustekinumab for Patients With Moderate-to-Severe Ulcerative Colitis: A Multicenter Real-World Canadian Study
Bibliographic record
Abstract
INTRODUCTION: We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naive and bio-exposed ulcerative colitis patients in a real-world setting. METHODS: Retrospective, Canadian multicenter cohort study. Primary outcomes were clinical remission and endoscopic remission. Key secondary outcomes included composite clinical and endoscopic response, safety, and persistence. Univariable logistic regression was conducted to examine associations between baseline factors and 12-month clinical and endoscopic response and remission. The primary focus was on the association between these outcomes and bioexposure status. RESULTS: A total of 198 patients were included, of whom 47.5% were female and 85.9% were younger than 65 years. The majority had severe endoscopic activity at baseline (47.5%, n = 87) and were bio-exposed (88.8%, n = 176; 33%, n = 66 previous failure of 3 or more biologics). Patients were followed for a median of 12.8 (interquartile range 8.2-22.1) months after induction. The overall clinical remission rates were 41.3% (69/167), 38.1% (56/147), and 43.6% (58/133) at 3, 6 and 12 months, respectively. Endoscopic remission rates (Mayo endoscopy score = 0) were 8.0% (7/88), 18.7% (23/123), and 12.5% (11/88) at 3, 6, and 12 months, respectively, and consistently higher in bio-naive patients compared with bio-exposed patients through 12 months ( P < 0.05 at all time points). Bio-naive patients were more likely to achieve endoscopic remission compared with bio-exposed (hazard ratio = 5.40, 95% confidence interval [CI]: 1.08-26.93). Adverse events were reported in 14.1% (18/198). DISCUSSION: In a highly refractory and largely bio-exposed population, a substantial proportion of patients with ulcerative colitis treated with ustekinumab can achieve clinical and endoscopic outcomes of importance after 12 months. Previous biologic exposure is associated with lower rates of endoscopic remission.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 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".