Assessing the role of ustekinumab dose escalation in Crohn’s disease patients with loss of response: an observational study
Bibliographic record
Abstract
Abstract Background/Aims Among Crohn’s disease patients with loss of response or non-response to ustekinumab (UST), there remains no clear strategy for dose escalation. Moreover, clinical associations and the role of therapeutic drug monitoring (TDM) are poorly understood. This study assessed response to escalation of UST therapy via increased dosing frequency or re-induction, as well as assessed associations of response. Methods A single-centre retrospective cohort study was performed. Adults who underwent dose escalation to every 4 weeks or reinduction of UST were included. The primary outcome was clinical and biochemical remission which was defined as a Harvey Bradshaw Index (HBI) of <5 and a C-reactive protein (CRP) level within the normal limit or a Fecal Calprotectin (FCP) level <250 ug/g. Partial response to treatment was defined as a 50% decrease from baseline HBI, CRP, or FCP. Results Thirty-nine patients were included. Clinical outcomes were assessed at a median of 17 weeks (IQR 12-21). Clinical and biochemical remission was achieved in 30.8% of patients (n = 12). Remission was found to be more likely among patients with lower baseline HBI (5.2 vs 9.0 P = .044) and younger patients (29.8 years vs 37.7 P = .046). No association was observed between baseline TDM values in the remission vs the non-remission group (3.32 ug/mL vs 2.91 ug/mL p=0.77). No severe adverse events were recorded. Conclusion UST dose escalation, in the form of reinduction or increased frequency to every 4 weeks may be effective among patients with loss of response or partial response, though predictors of response and strategy of escalation remain unclear.
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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 | 0.005 | 0.010 |
| 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 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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".