DOP021 Long-term effectiveness and safety of vedolizumab in patients with Crohn's disease: 5-year cumulative exposure of GEMINI 2 completers rolling into the GEMINI open-label extension study
Bibliographic record
Abstract
Background: Vedolizumab (VDZ), a humanised monoclonal antibody that targets α4β7 integrin, is approved for moderately to severely active Crohn's disease (CD) and ulcerative colitis. The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with CD who had completed GEMINI 2 [1] and were enrolled in GEMINI OLE. Methods: Analyses included pts who had responded to VDZ induction at Week (Wk) 6 and received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 2, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in Harvey–Bradshaw Index [HBI] of ≥3 points from baseline [BL]), clinical remission (HBI ≤4) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also assessed. Results: Of 308 pts in GEMINI 2 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 146 (47%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=81; anti-TNFα failure n=57). At the time of this analysis, 61 pts had completed 248 wks of cumulative VDZ treatment, 58 had discontinued (n=11 [19%] due to lack of continued benefit) and 27 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=61), 95% had clinical response and 89% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 59.4 and 29.8, respectively. In the safety population, 134 pts had adverse events (AEs); 15 discontinued due to AEs. Serious AEs were reported in 41 pts (in 3 pts these were drug-related; 8 pts discontinued as a consequence of serious AEs). One death (not drug-related; motor accident) was reported. Table 1. Effectiveness outcomes in patients with CD and cumulative VDZ exposure for up to 248 wks Conclusions: Long-term VDZ therapy (∼5 years) was associated with clinical benefits including clinical response, clinical remission and HRQoL improvements in pts with moderately to severely active CD who responded at Wk 6, completed GEMINI 2 and enrolled in OLE. Long-term VDZ therapy was associated with no unanticipated AEs, and the safety profile was consistent with that previously observed in a 3-year interim analysis of the OLE study. References: [1] Sandborn WJ, Feagan BG, Rutgeerts P, et al., (2013), Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease, N Engl J Med, 711–21
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".