Vedolizumab Outcomes in Real-world Bio-naive Ulcerative Colitis and Crohnʼs Disease Patients (EVOLVE) in North America
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ), a gut-selective monoclonal anti- a4β7-integrin antibody, is approved for the treatment (Tx) of moderate-to-severely active ulcerative colitis (UC) and Crohn's disease (CD). The study aimed to evaluate clinical effectiveness and safety of VDZ in patients with no prior exposure to biologic drugs for Tx of UC/CD. Methods: A retrospective multicentre cohort study of bio-naïve adult (≥18 years) UC and CD pts who initiated VDZ during the study period (CAN: May 19, 2015-Dec 31, 2016; US: May 20, 2014-Jul 31, 2017) was conducted. Pooled data were analysed and results are reported using descriptive statistics. Clinical response, remission and mucosal healing were assessed via hierarchical algorithms based on available clinical, biological and endoscopic assessments from VDZ Tx initiation to earliest of Tx discontinuation or end of follow-up; cumulative probability of clinical outcomes, Tx persistence and dose escalation (dose frequency increase for ≥2 consecutive infusions) were analysed by Kaplan Meier (KM) method. Results: The analysis included 249 pts (UC: 166; CD: 83) from 17 sites: mean (SD) age 44.4 (17.9) years; 59.8 % male; median (range: min-max) disease duration, 3.6 (0.07-35.0) years; median (range) follow-up, 16.1 (4.7-36.7) months. At 18 months, 78.6% of UC and 74.8% of CD pts persisted on VDZ Tx and at 24 months, 76.9% of UC and 74.8% of CD pts (Figure 1). Fifty-four pts (21.7%) had ≥1 VDZ dose escalation (median [range] time to first dose escalation: 6.2 [2.4-24.0] months). Of 84 pts on corticosteroids (CS) at VDZ Tx initiation, 58.3% discontinued CS Tx within 12 months; in CS-dependent pts (as recorded in the medical records), 21/43 (48.8%) discontinued CS within 12 months. Overall, 12.4% (UC: 13.2%; CD: 10.8%) and 4.8% (UC: 6.0%; CD: 2.4%) of pts discontinued VDZ due to primary non-response and secondary loss of response, respectively; 4.9% of pts had a serious adverse event (SAE) and 1.6% a serious infection (SI) and 2.0% and 0.8% of pts discontinued Tx due to SAEs and SIs, respectively. See Figure 2 for cumulative KM curves of clinical response, remission and mucosal healing.659_A Figure 1. Vedolizumab Treatment Persistence in Bio-naive Patients with Ulcerative Colitis and Crohn's Disease*659_B Figure 2. Cumulative Probability of Clinical Outcomes in Bio-naive Ulcerative Colitis and Crohn's Disease Patients Treated with Vedolizumab. A: Clinical Response, B: Clinical Remission, C: Mucosal HealingConclusion: High rates of Tx persistence (≥75%), clinical response, clinical remission and mucosal healing are observed in bio-naïve VDZ pts after 18 months. Outcomes were similar for UC and CD patients. These data support the long-term effectiveness and safety of VDZ in bio-naïve UC/CD patients. Results will need to be confirmed with a larger cohort.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| 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".