DOP026 Sustained remission with vedolizumab in patients with moderately to severely active ulcerative colitis: a GEMINI 1 post hoc analysis of week 14 remitters
Bibliographic record
Abstract
Background: Sustained remission is a key therapeutic goal in ulcerative colitis (UC). Vedolizumab (VDZ) was more effective than placebo as induction and maintenance therapy in patients (pts) with moderately to severely active UC in the GEMINI 1 study (NCT00783718). This post hoc analysis assessed sustained remission during the maintenance phase of GEMINI 1. Methods: Analyses included pts enrolled in GEMINI 1, who received 6 weeks (wks) of induction with placebo or VDZ and entered 46 wks of maintenance continuing placebo or VDZ, respectively; eligible pts could then enrol into an open-label extension (OLE) to receive VDZ every 4 wks. The primary aim was to assess sustained remission (remission at Wks 26, 38 and 52) in pts who achieved remission at Wk 14. Remission was defined as 1) clinical remission (partial Mayo Score [PMS] ≤2 points with no individual subscore >1 point) or 2) rectal bleeding subscore =0. For the analyses, pts who received VDZ maintenance, discontinued before Wk 52 and then entered the OLE had missing maintenance data imputed using OLE data. Results: In total, 620 pts received VDZ (Wk 6 responders and non-responders) and 149 received placebo throughout GEMINI 1. Patient characteristics were broadly similar between treatment groups. From Wk 4 onwards, a significantly higher proportion of pts receiving VDZ were in clinical remission versus placebo in the overall and anti-TNF-naïve populations; significance was achieved at Wk 26 in the anti-TNF failure population. At Wk 14, 203 (33%) pts receiving VDZ and 30 (20%) pts receiving placebo were in clinical remission based on PMS, and 293 (47%) pts receiving VDZ and 43 (29%) pts receiving placebo were in remission based on rectal bleeding subscore. Of pts in remission at Wk 14, the VDZ group had a higher proportion of pts with sustained remission versus placebo according to both PMS and rectal bleeding definitions (Table); significance was reached in both the overall and anti-TNF-naïve populations, and a similar nominal trend was observed in the anti-TNF failure population. Table 1. Patients with remission at Week 14 that was sustained for all visits at Weeks 26, 38 and 52 Conclusions: Wk 6 is most likely too early to ascertain the full clinical benefit of VDZ. VDZ showed a significant difference versus placebo in the proportion of pts achieving clinical remission as early as Wk 4 for the overall and anti-TNF naïve populations. However, as per label, assessment of the clinical benefit should be made after 10–14 wks. In pts with remission at Wk 14 in GEMINI 1, continued VDZ treatment resulted in ∼60% of pts maintaining sustained remission based on PMS and rectal bleeding subscore.
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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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 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) | 0.002 | 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".