A222 CLINICAL EFFECTIVENESS AND SAFETY OF USTEKINUMAB IN YOUTH WITH REFRACTORY INFLAMMATORY BOWEL DISEASE IN SAUDI ARABIA: A RETROSPECTIVE COHORT STUDY
Bibliographic record
Abstract
Abstract Background Inflammatory bowel disease (IBD) incidence and prevalence have been increasing worldwide with higher disease severity observed in pediatrics. Limited data exists on the effectiveness of ustekinumab (UST) in children. Aims To describe the effectiveness and safety of UST in pediatric patients with IBD. Methods A retrospective, single-center cohort study was conducted between January 2017 and February 2022. The study included patients ≤16 years of age who were treated with off-label UST and followed up for a minimum of one year. Clinical remission was defined as a decrease in the score on the Pediatric Crohn's Disease (CD) and Pediatric Ulcerative Colitis (UC) Activity Indices to ≤10 at week 52. Results A total of 13 patients who had failed anti-TNFα therapy were included, 8 (61.5%) with CD and 5 (38.5%) with UC. The median age of the patients was 13y (IQR: 11.5 to 14). UST treatment was initiated at a median of 3y (IQR: 2.3 to 7) after diagnosis. Ten patients (76.9%) achieved clinical remission. There were no statistically significant differences in baseline characteristics between patients who achieved and did not achieve clinical remission. Biochemical remission was achieved in 6 patients (46.2%). C-reactive protein levels decreased significantly in the remission group and insignificantly in the non-remission group. No significant changes were observed in erythrocyte sedimentation rate, albumin, or hemoglobin. BMI improved (Fig 1) and the need for corticosteroids significantly decreased after UST therapy in the remission group (P = 0.014). Endoscopy conducted post-treatment in 7 patients confirmed remission in 6 patients, with one patient showing clinical remission but not endoscopic remission. Adverse events included two instances of infection and once case of headache. Conclusions UST was effective as a secondary biologic therapy for the induction and maintenance of remission in patients with anti-TNFα refractory IBD. At one year, 84% of patients remained on UST with no severe adverse reactions reported. Future prospective large-scale studies are necessary to assess the therapeutic positioning and optimal dosing regimens of UST in pediatric IBD. Figure 1. Change in BMI Z-score throughout the study (P value of interaction = 0.049). Funding Agencies None
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Observational | low |
| gpt | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Observational | low |
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 | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 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, unvalidatedLabeled directly by 2 models reading the full record.
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".