P502 Ulcerative colitis patients on vedolizumab lacking response at induction phase continue to improve over the first 6 months of treatment
Bibliographic record
Abstract
Background: Vedolizumab, a gut-selective anti-integrin inhibitor, is a biologic agent indicated for ulcerative colitis (UC) treatment. We retrospectively assessed the real-world efficacy and safety of vedolizumab as induction and maintenance therapy in UC patients. Methods: Adult UC patients followed at a tertiary IBD center and treated with vedolizumab were included. All patients received infusions at 0, 2, and 6 weeks and then every 8 weeks. Six-month cumulative rates of clinical remission (CR, partial Mayo score≤2) and steroid-free clinical remission (SFCR) were assessed with Kaplan-Meier survival analyses. Univariate and multivariable Cox proportional hazard (PH) analyses were performed to identify among baseline variables independent predictors of clinical remission. Hospitalizations, surgeries and adverse events were recorded. Results: Fifty-seven patients were analyzed (Table 1). At 2 months, CR and SFCR were 37% and 30%. At 6 months, the cumulative rates of CR and SFCR were 49% and 44% (Table 1, Fig. 1). Among patients who were not in CR after 3 infusions (n=36) the probability of remission with continuation of vedolizumab was 25% (9/36) at 6 months. Pairwise analyses showed significant improvement in median partial Mayo scores and median CRP levels over the 6-month period compared to baseline (Fig. 1). Cox PH analysis revealed a 3-fold increase in the probability of clinical remission at 6 months among patients with baseline CRP levels less than 5mg/L (univariate analysis, hazard ratio [HR]: 2.55, 95% CI: 1.17–5.57, p=0.019; multivariate analysis, HR: 2.72, 95% CI: 1.24–5.97, p=0.012) and mild baseline disease (univariate analysis, HR: 2.48, 95% CI: 1.2–5.54, p=0.026; multivariate analysis, HR: 2.86, 95% CI: 1.27–6.44, p=0.011) compared with those who did not (Fig. 1). Cumulative rates of colectomy were 5%, 9%, and 14% at 2, 4 and 6 months respectively. The most common side effect was headache. Figure 1. Clinical remission rates in UC patients on conitnuous vedolizumab for 6 months. Conclusions: In our study, 35% of UC patients, most of whom were unresponsive to anti-TNFs, achieved CR after induction and 50% were in CR at six months with vedolizumab maintenance treatment. We did not observe severe adverse events. Our data would indicate that a significant proportion of patients who had not achieved response at 2 months may go on to achieve CR by 6 months of continued therapy.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.003 | 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".