P546 Vedolizumab outcomes in real-world bio-naive ulcerative colitis and Crohn’s disease patients (EVOLVE) in Canada: Interim results
Bibliographic record
Abstract
Vedolizumab (VDZ) is a gut-selective anti-α4β7 integrin indicated for the treatment (Tx) of moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Real-world outcomes in patients receiving VDZ as a first-line biologic Tx are limited. This study aims to evaluate real-world Tx patterns, clinical effectiveness and safety among biologic-naive UC and CD patients receiving VDZ in Canada. This is a retrospective chart review study of UC and CD patients who were biologic-naïve, aged ≥18 years at VDZ initiation (May 19, 2015–December 31, 2016) and had ≥6 months follow-up. Data collection spanned from VDZ Tx initiation to the earliest of death, date site initiated data abstraction or 6 months post-VDZ Tx discontinuation. Reported results are from a descriptive interim analysis of patient demographics and VDZ Tx patterns from two sites. VDZ dose escalation was defined as an increase in infusion frequency (≥2 consecutive infusions) at any point during the Tx period. Tx persistence was calculated using the Kaplan–Meier method. A total of 50 patients (CD: 16; UC: 34) were included in this interim analysis: mean (SD) age, 44.4 (15.5) years, 68.0% male, median (range) disease duration, 5.0 (0.1–35.0) years, median (range) follow-up, 12.9 (6.4–25.5) months. Fifteen patients (30.0%) experienced ≥1 VDZ dose escalation with a median (range) time to first dose escalation of 6.0 (2.7–18.1) months. At 12 months, 38 patients (76.0%) (24 UC [70.6%] and 14 CD [87.5%]) were persistent with VDZ Tx (Figure 1). Overall, 0 (0.0%) and 1 (6.3%) CD patients discontinued due to primary non-response (PNR) and secondary loss of response (SLOR), respectively, and 6 (17.6%) and 4 (11.8%) UC patients discontinued due to PNR and SLOR, respectively. Of 12 patients (24.0%) on concomitant corticosteroids (CS) at Tx initiation, 8 patients (66.7%) discontinued their CS Tx within 12 months. Treatment persistence of vedolizumab in biologic-naive Crohn’s disease and ulcerative colitis patients at 18 months. High treatment persistence and low dose escalation rates were observed with VDZ in biologic-naive UC and CD patients. Low rates of discontinuation due to both PNR and SLOR were observed. Two-thirds of patients receiving concomitant CS were able to discontinue their CS during VDZ treatment. These interim data suggest the long-term effectiveness and tolerability of first-line VDZ in UC and CD in real-world clinical practice.
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 | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".