Effect of Adalimumab Dose Escalation on Hospitalization Risk in Patients With Moderately to Severely Active Ulcerative Colitis
Bibliographic record
Abstract
Introduction: We assessed the effect of adalimumab dose escalation on risk of hospitalization in patients with moderately to severely active UC who did not respond or lost response after adalimumab induction therapy. Methods: Data were pooled from two randomized, double-blind, placebo-controlled phase 3 trials of adalimumab in patients with moderately to severely active UC (ULTRA 1 and 2: NCT00385736; NCT00408629). Patients randomized to adalimumab 160/80 mg induction therapy at weeks 0/2 followed by adalimumab 40 mg EOW who later dose escalated to 40 mg every week owing to non-response or loss of response were included in the analysis. Kaplan-Meier time-to-event analysis was used to estimate observed risks of all-cause and UC-related hospitalization within 90 days after dose escalation. Cox proportional hazards models were used to establish the relationship between hospitalization (both all-cause and UC-related) and partial Mayo scores after dose escalation, controlling for age, sex, prior anti-tumor necrosis factor (anti-TNF) status (naive or experienced), and partial Mayo score before dose escalation. This model's coefficients were then used to predict the 90-day all-cause and UC-related hospitalization risks had no dose escalation occurred, by assuming no changes in patients' partial Mayo scores in the period after dose escalation vs before dose escalation. Results: Of 122 patients who escalated to weekly adalimumab dosing, the majority were male (68%) and naive to anti-TNF agents (74%); mean age was 39.5 years and mean UC duration was 8.3 years. Mean partial Mayo score decreased from 6.8 before dose escalation to an average of 5.17 after dose escalation. For patients who dose escalated, the observed (Kaplan Meier) 90-day all-cause and UC-related hospitalization risks were 8.7% and 6.7%, respectively. The predicted 90-day all-cause and UC-related hospitalization risks, had patients continued on EOW therapy, were 13.0% and 10.3%, respectively. The relative risk of both all-cause and UC-related hospitalization in patients who dose escalated was lowered by 33.2% and 35.5%, respectively, compared with the predicted risk without dose escalation, reflecting the benefits of dose adjustment. Conclusion: Dose escalation of adalimumab in patients with moderately to severely active UC who did not respond or lost response after induction therapy reduced the 90-day risk of hospitalization and reflected a benefit of adalimumab dose escalation for treating these UC patients.
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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 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 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".