DOP019 Effect of vedolizumab treatment on extraintestinal manifestations in patients with Crohn’s disease: a GEMINI 2 post hoc analysis
Bibliographic record
Abstract
Background: Extraintestinal manifestations (EIMs) pose an additional burden to patients with IBD (reported frequency: 6–47%) [1]. Vedolizumab (VDZ) is approved for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis. This post hoc exploratory analysis investigated the effect of VDZ treatment on existing and new EIMs in patients with CD enrolled in GEMINI 2 (NCT00783692). Methods: Data were collected on 5 categories of EIM and assessed using the following definitions: sustained resolution (absence of an EIM symptom, sustained to study end), worsening of existing EIM and occurrence of new EIM. For the category of arthritis/arthralgia (ar/ar), Kaplan–Meier (KM) estimates were used to describe “time to sustained resolution”. A multivariate Cox regression adjusting for potential baseline confounding factors was conducted. In patients receiving corticosteroids (CS), the influence of steroid tapering on the occurrence of new or worsening ar/ar was explored, with prednisone equivalent dose (≤30 mg) as a time-dependent covariate. Results: Patients (pts) received VDZ (n=814), VDZ/placebo (VDZ/PLA; VDZ to Week 6, PLA Week 6–52; n=153) or PLA only (n=148). Baseline EIM incidence was similar across treatment groups (Table). Further analyses focussed on ar/ar as the most common EIM. Predicted annual rates of sustained resolution of ar/ar were 51% (VDZ), 41% (VDZ/PLA) and 36% (PLA; Figure). VDZ pts were 32% more likely to achieve sustained resolution of ar/ar versus PLA (not significant [NS], Table) and 21% less likely to have a worsening/new occurrence (NS, Table). In pts receiving CS (n=530), adjustment for CS withdrawal resulted in ∼4% increased likelihood of new or worsening ar/ar in all groups over time (30 mg dose reduction HR 1.04 [95% CI: 0.67–1.60], NS). Hazard reduction for the VDZ groups versus those on PLA was similar (VDZ, 0.73 [95% CI: 0.44–1.22], NS; VDZ/PLA, 0.72 [95% CI: 0.37–1.39], NS). Table 1. EIMs in patients with CD enrolled in GEMINI 2 Figure 1. Time to sustained resolution of arthritis/arthralgia (n=516). PLA, placebo; VDZ, vedolizumab. Conclusions: In this post hoc exploratory analysis there was a trend for both reduced incidence of new or worsening ar/ar and increased rates of sustained resolution of ar/ar in pts receiving VDZ. CS tapering increased the probability of ar/ar in all groups. GEMINI 2 was not sufficiently powered to assess worsening/new occurrences of other EIMs. References: [1] Vavricka SR, Schoepfer A, Scharl M, et al., (2015), Extraintestinal Manifestations of Inflammatory Bowel Disease, Inflamm Bowel Dis, 1982–92
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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 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.007 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".