Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated With Vedolizumab During the GEMINI 1 Trial
Bibliographic record
Abstract
Introduction: Corticosteroids (CS) are effective for the short-term treatment of patients with ulcerative colitis (UC), but serious side effects prohibit long-term use. In the GEMINI 1 study, a significantly higher percentage of patients with moderately to severely active UC were in CS-free remission at week 52 with vedolizumab (VDZ) treatment than with placebo (PBO).1 Methods: In GEMINI 1, patients who responded to VDZ induction therapy at week 6 were re-randomized to PBO or VDZ for 46 weeks. From week 6 onward, patients with clinical response to VDZ began a CS tapering regimen. We characterized CS dose reductions achieved with VDZ therapy in exploratory and post hoc analyses of patients with baseline (week 0) CS use (≤30 mg/day prednisone or equivalent). Median CS dose over time, change from baseline CS dose, and CS-free status at week 52 were summarized overall and by tumor necrosis factor antagonist (anti-TNF) treatment (naive or failure) history. Results: Among patients with baseline CS use, 74% decreased their CS dose with VDZ treatment compared with 57% with PBO (Table). At week 52, 56% of VDZ-treated patients compared with 32% of PBO-treated patients were on ≤7.5 mg/day of CS (Table); the median CS dose was 2.5 mg/day for VDZ-treated patients and 10.0 mg/day for PBO-treated patients. Numerically higher percentages of VDZ-treated patients were CS-free for 90 or 180 consecutive days at week 52 than PBO-treated patients (Table). Similar trends were observed in the anti-TNF-naïve and anti-TNF-failure populations (Table). Conclusion: Numerically greater reductions in CS use were achieved with VDZ maintenance therapy compared with PBO. At week 52, VDZ therapy was associated with numerically higher percentages of CS-free patients and patients who were CS-free for 90 or 180 consecutive days than PBO. Interpretation of these post hoc analyses, including the degree of dose reduction, is limited by differing initiation weeks for CS tapering per patient and small sample sizes.Table 1: CS Dose Reductions at Week 52
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| 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".