P0588 Efficacy and health-related quality of life associated with second-line vedolizumab after one prior first-line anti-tumour necrosis factor treatment in patients with active ulcerative colitis: A meta-analysis of the GEMINI-1 and VISIBLE-1 trials
Bibliographic record
Abstract
Abstract Background Vedolizumab (VDZ) is a monoclonal antibody approved for adults with moderately to severely active ulcerative colitis (UC) and an inadequate response/intolerance to conventional therapy or anti-tumour necrosis factor (TNF) treatment. There is published evidence supporting the use of VDZ as a first-line biologic in patients with UC, but additional efficacy data for second-line VDZ (after first-line anti-TNF treatment) are required to define its optimal position in the treatment sequence. We conducted a meta-analysis of the efficacy and health-related quality of life (HRQoL) associated with second-line VDZ treatment exposure in patients with UC using data from the randomized, placebo (PBO)-controlled phase 3 GEMINI-1/VISIBLE-1 trials. Methods GEMINI-1 (NCT00783718) evaluated intravenous (IV) VDZ as induction/maintenance treatment in patients with active UC.1 VISIBLE-1 (NCT02611830) assessed IV/subcutaneous maintenance VDZ in patients with moderately/severely active UC.2 Patients who received first-line anti-TNF treatment within 5 years before trial enrolment were included in the meta-analysis. The primary outcome was clinical remission (defined as Adapted Mayo Score [AMS] 1 or 2; Figure). Secondary outcomes included corticosteroid-free remission, mucosal healing and HRQoL (measured via the Inflammatory Bowel Disease Questionnaire and EuroQoL-5 Dimension Visual Analogue Scale). Outcomes were assessed at Week 52. Study-specific treatment effects were estimated using generalized linear models. Efficacy of VDZ vs PBO was compared using fixed-effects models. Regression analyses assessed treatment effects, adjusting for disease location/duration and previous corticosteroid use. Results In total, 137 patients from GEMINI-1/VISIBLE-1 were included (VDZ, n=89; PBO, n=48). Patient characteristics were similar across cohorts, but the mean (standard deviation) disease duration ranged from 6.6 (4.4) years (GEMINI-1 VDZ IV cohort) to 9.9 (10.1) years (VISIBLE-1 PBO cohort). Second-line VDZ was associated with a higher likelihood of achieving clinical remission (AMS 1 and 2; Figure) and all secondary outcomes, including improved HRQoL, at Week 52 vs PBO (Table). Regression analysis showed that patients treated with VDZ were 11.35 (95% confidence interval 3.25–39.63) times more likely to achieve clinical remission (defined as AMS 1) vs PBO. Conclusion Second-line VDZ after first-line anti-TNF treatment significantly increased the likelihood of achieving clinical remission, mucosal healing and improved HRQoL at Week 52 vs PBO in patients with UC. The small sample size and heterogeneity observed in some outcomes warrant further research to strengthen these findings. References 1. Feagan BG et al. N Engl J Med 2013;369:699-710. 2. Sandborn WJ et al. Gastroenterology 2020;158:562-572 e12. 3. Sandborn W. J. et al. Crohns Colitis 360 2023;6:otad076.
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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 | 0.009 | 0.012 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.011 | 0.038 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".