Ustekinumab Use in Crohnʼs Disease: Real-Life Canadian Experience
Bibliographic record
Abstract
Introduction: There is emerging evidence for ustekinumab use in Crohn's disease (CD). Limiting applicability of outcomes to a wider population is the uncertain impact of the difference between intravenous and currently available subcutaneous induction formulations. Methods: Retrospective, observational study of two different induction regimens was conducted. Standard dosing was 90mg subcutaneously(SC) at Week 0,1 and 2; higher dose induction 270mg SC at Week 0 and 180mg SC at Weeks 1 and 2. Maintenance dosing was 90mg SC every 8 weeks for both induction regimens. Symptomatic response defined as physician documentation of improvement of CD-associated symptoms, withdrawal of steroids and continuation of therapy. If baseline parameters (C-reactive protein, haemoglobin or faecal calprotectin) were elevated (applicable) and assessed at 3 months (available), biochemical response considered. When available, endoscopic and radiological evidence of response and improvement assessed (defined as resolution or improvement of extent and severity of endoscopic or radiological lesions). Results: Fifty-three patients commenced ustekinumab for luminal CD from September 2012 to January 2016. (Figure 1) Sixteen patients induced with higher dose schedule. Maintenance dose escalation occurred in 14 patients. Symptomatic response assessed in 45 patients (Table 1); at 3 months 24 had response and 21 no response or stopped therapy. Sixty-four (9/14) and 48 (15/31) percent receiving high and standard induction dose schedules had symptomatic response. Biochemical improvement accompanied symptomatic response in 53% (8/15) with applicable and available testing at 3 months. Symptomatic response reported in ˜65% of patients at six (18/27) and 12 months (13/20). Assessment beyond 12 months available for 16 patients, with 9 having ongoing symptomatic response and 7 ceasing therapy. Endoscopic or radiologic response or improvement achieved in 62% (16/26) assessed.Figure 1Table 1: Demographic and Clinical CharacteristicsConclusion: Fifty-three percent of patients had a symptomatic response at three months, with a numerically greater proportion receiving the higher induction strategy. Sixty-two percent with endoscopic or radiologic assessment had improvement or complete response. Results provide further encouragement for a therapeutic benefit of ustekinumab in CD, with suggestion that higher dose subcutaneous induction may be an alternative to induction with the intravenous formulation.
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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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| 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".