DOP056. Pharmacokinetics and exposure-response relationships of golimumab in paediatric patients with moderate-to-severe ulcerative colitis: results from a multicentre open-label study
Bibliographic record
Abstract
Background: Crohn's disease has been linked to changes in the microbiome and to pathobionts such as adherent strains of E.coli.These strains may exist in the lumen, upon the epithelium as a biofilm or as intracellular bacteria in macrophages.An ideal antibiotic would be effective in all 3 compartments, which is not the case for current antibiotics in use, such as quinolones, rifaximin, or azoles.Azithromycin is unique as it is active in all 3 compartments, and it induces prolonged apoptosis of activated T-cells.We therefore evaluated a combination of azithromycin and metronidazole in a randomised controlled trial.Methods: This was a single blinded randomised controlled trial in 73 children over 8 weeks.Patients with 10 ≤ Paediatric Crohn's Disease Activity Index (PCDAI) ≤ 40 were randomised to azithromycin 7.5 mg/kg, 5 consecutive days a week for the first 4 weeks and 3 consecutive days a week for the last 4 weeks coupled with metronidazole 20 mg/kg day (Group 1) or metronidazole 20 mg/kg per day as sole therapy (Group 2), for 8 weeks.Patients with worsening disease or no response at week 4 or failing to achieve remission by week 8 in group 2 could have azithromycin added to the therapy.The primary endpoint was intention-to-treat response (drop 12.5 points) or remission (PCDAI ≤ 10) at week 8. Secondary endpoints included steroid-free remission at week 8 and normal CRP remission.Results: In the study, 73 patients (mean age 13.82 ± 3.10 SD) were enrolled: 35 to Group 1 and 38 to Group 2. The response rates
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".