Efficacy of Vedolizumab Maintenance Therapy With and Without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2
Bibliographic record
Abstract
Introduction: In GEMINI 1 and GEMINI 2, vedolizumab (VDZ) was safe and effective in patients with ulcerative colitis (UC) or Crohn's disease (CD), respectively, on stable doses of immunosuppressants.1,2 The effect of discontinuing immunosuppressants in patients who responded to VDZ induction therapy in these studies has not been characterized. Methods: Patients who responded to VDZ at week 6 were re-randomized to placebo (VDZ/PBO) or VDZ every 4 weeks (VDZ/VDZ Q4W) or 8 weeks (VDZ/VDZ Q8W) for 46 weeks. At United States (US) sites, re-randomized patients discontinued immunosuppressant use at week 6. At non-US sites, patients could continue to use immunosuppressants; doses were to remain stable throughout the study unless the medication was discontinued because of a medication-related toxicity. Clinical efficacy, VDZ serum concentration, and immunogenicity (via an enzyme-linked immunosorbent assay) data were evaluated post hoc in patients with baseline (week 0) immunosuppressant use stratified by region (US vs non-US). Results: At week 52, rates of clinical remission, clinical response, mucosal healing (UC), and corticosteroid-free remission were numerically higher with VDZ, irrespective of baseline immunosuppressant use (Table). Mean trough concentrations were similar between US and non-US patients at week 46 (Table). The US and non-US sites had similar numbers of patients who were positive for anti-VDZ antibodies during VDZ maintenance therapy (Table). Conclusion: Discontinuing immunosuppressants did not appear to substantially affect the clinical efficacy of VDZ maintenance therapy. Interpretation of these post hoc analyses is limited by the crossregional comparison and the relatively small sample sizes.Table 1: Maintenance VDZ With and Without Continued Immunosuppressant Use
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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".