A108 USTEKINUMAB IS EFFECTIVE FOR INDUCING CLINICAL, ENDOSCOPIC, AND RADIOGRAPHIC RESPONSE IN REFRACTORY MODERATE-TO-SEVERE CROHN’S DISEASE: A MULTICENTRE COHORT STUDY
Bibliographic record
Abstract
Ustekinumab is a monoclonal antibody targeting the p40 subunit of interleukins 12 and 23. Gastroenterologists have begun to prescribe ustekinumab off-label for treatment of Crohn’s disease (CD) due to promising clinical trials but robust open label data is lacking Assess the real-world efficacy of ustekinumab for inducing clinical, endoscopic, and radiographic response in CD A retrospective multicentre cohort study was performed at two academic institutions (University of Calgary, University of Alberta) on CD patients receiving ustekinumab between 2011–2016. The primary outcome was achievement of clinical or objective response at 3, 6, and 12 months after induction. Clinical response was defined by symptom improvement and reduction in Harvey Bradshaw Index of >2 points with tapering off corticosteroids. Objective response was defined by improvement in endoscopic or radiographic CD, as assessed by ileocolonoscopy, contrast-enhanced ultrasound, or CT/MR enterography We identified 167 CD patients treated with ustekinumab. Median follow-up was 39.0 weeks (IQR 23.3–87.1 weeks). 95.2% (159/167) had previously failed anti-TNF therapy. 63 patients (37.7%) had clinical response at 3 months. Among 143 patients followed for 6 months or discontinuing drug prior to 6 months, clinical response was achieved in 57.0% (85/149). At 12 months, clinical response was achieved in 54.2% (58/107) of patients. Endoscopic or radiographic response was demonstrated in 48.6% of patients (54/111) at 6 months and 46.9% of patients at 12 months (38/81). Fifty-three patients (31.1%) experienced an adverse event: 8 patients discontinued therapy due to intolerable side effects (4.8%) To the best of our knowledge, this multicentre cohort study is the largest reported open label experience with ustekinumab for CD. We found that ustekinumab was a safe and effective therapy for inducing steroid-free clinical and objective endoscopic and radiographic response Table 1 – Baseline patient characteristics Figure 1 – Steroid-free symptomatic and objective response to ustekinumab therapy CAG
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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) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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".