Post Analysis of Polyps in 9 Short Bowel Syndrome Patients Treated with Teduglutide
Bibliographic record
Abstract
Introduction: Preclinical data raise the possibility that teduglutide may be associated with a risk of small intestinal and/or colonic neoplasia. This report aims to evaluate data from 2 clinical trials in patients with short bowel syndrome (SBS) who reported polyps at baseline or during long-term teduglutide treatment. Methods: Post hoc analysis of data was reported in patient e-case forms (eCRFs) regarding gastrointestinal polyps at baseline and over the course of 2 therapeutic trials of teduglutide (STEPS: NCT00798967, EudraCT2008-006193-15; STEPS-2: NCT00930644, EudraCT2009-011679-65). A baseline colonoscopy was required unless a normal colonoscopy had been performed Results: Of the patients enrolled (STEPS, n=86; STEPS-2, n=88), 54 who had not undergone prior colectomy received a baseline colonoscopy and 50 received a study completion colonoscopy (remaining patients refused or no colon was present). Baseline colonic polyps were reported in 9 patients (ages 39-75 years; women 67%); per inclusion criteria they were removed before treatment initiation. By the end of STEPS-2, 9 patients (ages 35-63 years; women, 67%) had reported polyps. In 6 of these 9 patients, polyps were recorded as a treatment-emergent adverse event (TEAE). Patients had been on teduglutide for 3 months (1 patient, TEAE), 8 months (1 patient, TEAE), 10 months (1 patient, TEAE), 24 months (5 patients, 3 TEAE) and 30 months (1 patient, 0 TEAE) at polyp detection. Polyp locations were colon (7 patients), duodenum (1 patient), and unknown (1 patient). Recorded polyp sizes were 2-7 mm (4 patients). 7 patient eCRFs noted that biopsies were performed; 2 recorded low-grade dysplasia (rectal/colorectal polyps), but none recorded overt malignancy. Conclusion: Polyps were reported in 9 of 50 patients receiving long-term teduglutide who had a colonoscopy at study completion (106.3 patient-years exposure). There were no reports of malignancy related to the presence of these polyps. Additional information regarding polyp incidence will be acquired from an ongoing SBS registry.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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".