P626 Ustekinumab for the treatment of perianal fistulas in patients with Crohn's disease
Bibliographic record
Abstract
Background: Ustekinumab (UST), an interleukin-12/23p40 inhibitor, is effective in Crohn's disease (CD). Little is known on its efficacy in perianal fistulizing disease. To date, perianal outcomes using UST have been reported in only 18 patients. We report on the efficacy of UST on perianal fistulizing disease in CD. We also describe UST trough concentration, clinical, biomarker and endoscopic response in CD patients with perianal fistulas. Methods: Anti-TNF refractory CD patients treated with UST (2013–2015) at the McGill University Health Centre were recruited. All patients were induced with UST 90mg SC at week 0, 1, 2 then maintained with UST 90mg SC every 4 or 8 weeks. At 6 months 77.4% were receiving UST every 4 weeks. The primary endpoint was >50% reduction from baseline in the number of draining fistulas. The secondary endpoint was closure of all fistulas. Outcomes were assessed for longitudinal patients and cross sectional patients ≥6 months. A combined cohort was analyzed at ≥6 months, when available. UST and UST antibody concentrations were assessed using a liquid phase assay (HMSA, Prometheus Laboratories, San Diego, CA, USA). Results: Sixty-two patients were recruited. 17 patients had a history of perianal fistulizing disease. 6 patients had actively draining fistulas prior to initiating UST. At ≥6 months, 66% (4/6) of patients had a >50% reduction from baseline in the number of draining fistulas, and 33% (2/6) patients had closure of all fistulas. At ≥6 months, of the 6 patients who had active fistulas at commencement of UST, 3/6 (50%) attained clinical response while 2/6 (33%) attained clinical remission as determined by HBI assessment (HBI<5). 2/6 (33%) achieved steroid free clinical remission. Endoscopic response was attained in 3/6 (50%) patients while 2/6 (33%) attained endoscopic remission. Mean UST trough concentration at ≥ week 26 was 4.85 ug/ml. In those with >50% reduction in draining fistulas (n=4) mean UST trough concentrations were 5.0 ug/ml compared to 4.6 ug/ml in those without (n=2). Conclusions: UST was effective in achieving reduction in perianal fistulas in a small series of anti-TNF refractory CD patients. Given the limited information on this subject, this series adds to the existing data on response of perianal fistulas with UST. However, larger studies are required to confirm these findings.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".