Safety and efficacy of vedolizumab in pediatric inflammatory bowel disease with emphasis on the very-early-onset group
Bibliographic record
Abstract
Introduction Vedolizumab (VDZ) is effective in the induction and maintenance of remission in adults with inflammatory bowel disease (IBD). Pediatric data are still limited. This retrospective cohort study aimed to assess the safety and efficacy of VDZ in pediatric IBD including very-early-onset IBD (VEO-IBD). Material and methods A review of pediatric IBD patients receiving VDZ was conducted. Laboratory parameters, nutritional status, and disease activity scores were compared between each follow-up visit and between two groups divided by age of disease onset – VEO-IBD (age of onset < 6-years-old) and non-VEO-IBD (age of onset ≥ 6 years < 17 years). The primary outcome was clinical response after induction therapy (at 4th dose visit). The secondary outcome was clinical remission after induction (at 4th dose visit) and maintenance phase (at 10th dose visit). Statistical considerations were included. Results Seventy-two patients with pediatric IBD were included: 12 with Crohn disease (CD), 60 with ulcerative colitis (UC). The definition of VEO-IBD was met by 21 patients. After the induction phase, a clinical response was observed in 60/72 (83.3%) patients (51/60 with UC and 9/12 with CD) and clinical remission in 44/72 (61.1%) patients (40/60 with UC and 4/12 with CD). Clinical remission after the maintenance phase was achieved by 22/72 (30.6%) patients (16/60 with UC and 6/12 with CD). Improvement in the patients’ laboratory parameters and nutritional status was observed. No significant differences were observed in VDZ response between VEO-IBD and non-VEO-IBD. Conclusions Vedolizumab was safe and effective in the treatment of pediatric IBD irrespective of age of disease onset.
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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) | 0.001 | 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 | 0.001 |
| 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".