A93 POST-INDUCTION INFLIXIMAB TROUGH LEVELS VARY WIDELY AND AID IN INDIVIDUALIZING INFLIXIMAB MAINTENANCE THERAPY FOR PEDIATRIC IBD
Bibliographic record
Abstract
Clinical trial data in patients with IBD shows that infliximab (IFX) efficacy correlates with trough drug levels. Absence of drug predisposes to antibody formation and secondary loss of response. We aimed to individualize IFX regimens through early post-induction drug levels in pediatric patients with Crohn’s disease (CD) and ulcerative colitis (UC). Starting September 2013 at SickKids Hospital, Toronto children/adolescents initiating IFX via a 3-dose induction regimen were given their first maintenance dose earlier than the conventional 8 weeks following 3rd induction dose. IFX trough levels, measured by ELISA at the time of first maintenance infusion were compared between CD and UC. The influence of baseline characteristics such as physician global assessment (PGA) of disease activity, albumin and hsCRP on trough levels pre-dose 4 was assessed. 125 patients with IBD (81 CD, 44 UC; 60% male) were identified (Table). CD and UC patients were similar in age, gender, disease duration, BMI, and hsCRP. However, UC patients had higher disease activity, lower albumin, and higher steroid use at baseline. 81 CD patients infused in standard fashion (weeks 0, 2, 6) had a median dose of 5.3 mg/kg (IQR 5.0–5.5) across 3 induction doses. They had median trough levels at week 12 of 9.3 mcg/mL (IQR 4.8–13.4). 65/81 (80%) received concomitant immunomodulator during induction. 22 (27%) CD patients had a week 12 trough level <5 mcg/mL, and 18 (22%) had a level <3 mcg/mL. 44 UC patients were induced more intensively, with many given 3 doses over 4–5 weeks. They also received higher doses (median 6.3 mg/kg over 3 induction doses) compared to CD (p<0.001). All UC patients were given their first maintenance dose 4 weeks following the 3rd induction dose. The median trough level of 10.2 mcg/mL (IQR 3.7–14.4) was similar to CD patients dosed 6 weeks after their 3rd infusion (Figure). Dose 4 trough levels were <7mcg/mL for 17 (37%) UC patients and <3mcg/mL for 9 (21%). Post-induction trough levels are variable for pediatric IBD patients. For many patients, standard maintenance infusions beginning at week 14 would result in suboptimal trough levels. In this cohort, patients with UC cleared drug more rapidly, requiring more intensive dosing to achieve comparable drug levels post induction. Baseline characteristics None
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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 | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 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 | 0.001 |
| 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".