Corticosteroid Dose Reduction With Vedolizumab Treatment of Crohnʼs Disease During the GEMINI 2 Trial
Bibliographic record
Abstract
Introduction: Corticosteroids (CS) can effectively induce remission of Crohn's disease (CD), but serious side effects prohibit long-term use. Vedolizumab (VDZ) maintenance therapy resulted in a significantly higher percentage of patients with CS-free remission at week 52 versus placebo (PBO) in the GEMINI 2 study of moderately to severely active CD.1 Methods: In GEMINI 2, 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 began a CS tapering regimen. With exploratory and post hoc analyses, we characterized CS dose reductions following VDZ therapy in the population of patients on stable CS doses (≤30 mg/day prednisone or equivalent) at baseline (week 0). 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: At week 52, 68% of patients with baseline CS use decreased their CS dose with VDZ treatment compared with 62% with PBO (Table). The median CS dose in either treatment group (VDZ or PBO) at week 52 was 5 mg/day. Higher percentages of patients (overall and anti-TNF-naïve) had doses ≤7.5 mg/day with VDZ versus PBO (Table). In anti-TNF-naïve patients, the median CS dose at week 52 was 2.7 mg/day with VDZ and 5.0 mg/day with PBO. At week 52, higher percentages of VDZ-treated patients were CS-free for 90 or 180 consecutive days than PBO-treated patients (Table). Conclusion: VDZ maintenance therapy was associated with numerically higher percentages of CS-free patients at week 52 and patients who were CS-free for 90 or 180 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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".