DOP79 Effect of vedolizumab on surgical rates in IBD: post hoc analysis from the GEMINI trials
Bibliographic record
Abstract
Vedolizumab (VDZ) is a safe and effective treatment for moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD); however, effects on surgical rates have not yet been evaluated. This study aimed (1) to compare the surgical incidence rates of VDZ and placebo (PLA) in GEMINI I (UC; NCT00783718) and II (CD; NCT00783692); and (2) to describe the surgical incidence rates through year 5 from the GEMINI LTS trial (UC and CD; NCT00790933). Data were pooled from Week 6 induction VDZ responders who were randomised to VDZ or PLA maintenance (intent-to-treat [ITT] maintenance populations) from GEMINI I1 and II,2 and from patients receiving VDZ in the GEMINI LTS trial.3,4 Using the Kaplan–Meier product-limit method, we estimated ‘time to first surgery’ through 1 year (VDZ and PLA groups from GEMINI I and II) and 5 years (VDZ1 and VDZ2 groups from GEMINI LTS. VDZ1 = VDZ throughout; VDZ2 = PLA from Week 6 to 1 year, then VDZ for the LTS study). Patients without surgery were censored at the last follow-up date through 1 year and 5 years. The log-rank test was used for comparisons between groups. The analysis included 834 patients in total. Mean ages were 40.0 and 35.7 years for patients with UC and CD, respectively; proportions of prior tumour necrosis factor antagonist failure were 39.9 and 54.9%, and mean disease duration times were 7.2 and 8.6 years. Figure 1 shows cumulative surgical incidence rates for the study groups, and the log-rank comparisons at 1 year (VDZ and PLA groups) and 5 years (VDZ1 and VDZ2 groups). In this population of patients with moderately to severely active UC or CD, surgery rates within the first year of observation were lower in patients assigned to VDZ than those who received PLA with a significant difference observed in UC. For patients who continued treatment for up to 5 years, VDZ provided long-term benefit in both diseases with low rates of surgical intervention. The post hoc nature of the analysis and the small number of surgical events require further real-world evaluation of the ability of VDZ to reduce surgical rates in patients with UC and CD. Abstract OP79 – Figure 1. Kaplan–Meier surgery rate estimates throughout 5 years in the GEMINI maintenance studies References 1. Feagan BG, Rutgeerts P, Sands BE et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2013;369:699–710. 2. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013;369:711–21. 3. Loftus EV Jr, Colombel JF, Feagan BG, et al. Long-term efficacy of vedolizumab for ulcerative colitis. J Crohns Colitis 2017;11:400–11. 4. Vermeire S, Loftus EV Jr, Colombel JF, et al. Long-term efficacy of vedolizumab for Crohn's disease. J Crohns Colitis 2017;11:412–24.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.014 | 0.016 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".