Vedolizumab Demonstrates Early Symptomatic Improvement in Ulcerative Colitis: A GEMINI 1 Post hoc Analysis
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ) achieves long term clinical remission and mucosal healing in patients (pts) with moderately to severely active ulcerative colitis (UC).1 Relief of rectal bleeding (RB) and stool frequency (SF) remain important treatment goals for pts and key indicators of remission for physicians. We aimed to characterize early symptomatic response with VDZ, specifically evaluating the timing of RB and SF improvement. Methods: We assessed symptomatic improvement with VDZ through post hoc analysis of GEMINI 1 data. Pts with active UC were randomized to receive double-blind placebo (PBO) or VDZ at weeks (wks) 0 and 2 during the 6-wk induction phase. Mayo clinic SF subscores (SFS) and RB subscore (RBS) were evaluated at 0, 2, 4, and 6 wks. Mean subscores and mean percent change from baseline (BL) were reported for the overall population and in those who were tumor necrosis factor antagonist (anti-TNF) naïve. The percentages of pts who reached SFS ≤1 and/or RBS of 0 were also determined. Results: In anti-TNF-naïve pts, greater percentage decreases in mean SFS from BL were observed with VDZ than with PBO, reaching statistical significance at wks 4 and 6 as suggested by the non-overlapping 95% confidence intervals (Fig. 1). The same trends were observed in the overall population without reaching statistical significance. Similarly, a numerically greater percentage decrease from BL in RBS was observed with VDZ than with PBO, reaching statistical significance at wk 6 in both anti-TNF-naïve and overall populations (Fig. 2). Significantly larger percentages of pts overall achieved SFS ≤1 or RBS of 0 with VDZ than with PBO at wk 6 and as early as wk 2 among the anti-TNF-naïve population (Table). A composite of SFS ≤1 and RBS of 0 was achieved in a significantly greater percentage of pts with VDZ than PBO at all time points (Table).Figure: Percent change from baseline in stool frequency subscore *Data points represent adjusted percentage change from BL mean, where adjustment is for BL value and treatment. Error bars represent standard error and values in parentheses are 95% CI. Patients with BL SFS=0 were excluded from this analysis. Of note, the number of patients varies per study population at weeks 2, 4 and 6 and is reported below the x-axis. Abbreviations: anti-TNF, tumor necrosis factor antagonist; BL, baseline; CI, confidence interval; PBO, placebo; pts, patients; SFS, stool frequency subscore; VDZ, vedolizumab.Figure: Percent change from baseline in rectal bleeding subscore *Data points represent adjusted percentage change from BL mean, where adjustment is for BL value and treatment. Error bars represent standard error and values in parentheses represent 95% CI. Patients with BL RBS=0 were excluded from this analysis. Of note, the number of patients varies per study population at weeks 2, 4 and 6 and is reported below the x-axis. Abbreviations: anti-TNF, tumor necrosis factor antagonist; BL, baseline; CI, confidence interval; PBO, placebo; pts, patients; RBS, rectal bleeding subscore; VDZ, vedolizumab.Table: Table. Proportion of patients who achieved SFS ≤1, RBS = 0, or bothConclusion: Symptomatic improvements were achieved with VDZ as early as wk 2, with greater differences from PBO observed in anti-TNF-naïve pts. These results highlight the rapid onset of VDZ in UC; however, assessing efficacy at wk 14 and beyond for those who exhibit a more gradual response should be used to inform clinical practice.
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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 | 0.008 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| 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) | 0.004 | 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".