Therapeutic Drug Monitoring to Guide Infliximab Dose Adjustment is Associated with Better Endoscopic Outcomes than Clinical Decision Making Alone in Active Inflammatory Bowel Disease
Bibliographic record
Abstract
BACKGROUND: Adequate infliximab (IFX) levels are associated with favorable outcomes in inflammatory bowel disease. Using therapeutic drug monitoring (TDM) to guide dosing is cost effective and associated with clinical improvement, but effect on endoscopic outcomes remains unclear. METHODS: Primary responders to IFX who underwent dose escalation (2008-2014) were reviewed. Patients with active endoscopic disease were included. Two cohorts were examined: TDM-based decision to escalate (TDM) and clinical decision (non-TDM). Outcomes recorded at median 6 months after adjustment included endoscopic remission (Mayo <1, Simple Endoscopic Score for Crohn's Disease <3), C-reactive protein, and inflammatory bowel disease-specific health care utilization. Postadjustment IFX and antibodies to infliximab levels discriminant for endoscopic remission were determined. Multivariable regression evaluated independent predictors of remission. RESULTS: Of note, 312 dose optimizations were examined (149 TDM and 163 non-TDM). Clinically, groups were similar. Sixty-three percent TDM attained postadjustment endoscopic remission compared with 48% non-TDM (P < 0.05). Sixty-nine percentage TDM had significant clinical response (57% non-TDM [P < 0.01]); fewer were hospitalized (22% TDM versus 35% non-TDM, P = 0.025). Patients with ulcerative colitis had shorter time to escalation (10 versus 20 mo, P < 0.0001). Median IFX levels increased after escalation in TDM (1.5 [pre] and 11 μg/mL [post]; P < 0.0001) and were higher than non-TDM postadjustment levels (11 versus 6.5 μg/mL, P = 0.015). Postadjustment IFX >4.5 μg/mL (area under curve = 0.8; 95% confidence interval, 0.71-0.88) and antibodies to infliximab <3.3 U/mL (area under curve = 0.70; 95% confidence interval, 0.63-0.81) were associated with endoscopic remission. Multivariable analysis showed that IFX concentration (odds ratio 1.2 [95% confidence interval, 1.1-1.3]; P < 0.0001) remained an independent predictor of endoscopic remission. CONCLUSIONS: TDM before dose adjustment is associated with higher postadjustment levels and endoscopic remission.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".