Long-term clinical experience with vedolizumab for the treatment of inflammatory bowel disease
Bibliographic record
Abstract
Vedolizumab (previous versions MLN0002, MLN02, LDP-02) is a gut-selective, anti-inflammatory monoclonal antibody in phase 3 development for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). Vedolizumab binds to the α4β7 integrin, antagonizing its interaction with MAdCAM-1 and thereby interfering with migration of gut-homing leukocytes. Here we report a long-term clinical experience with vedolizumab for the treatment of patients with mild to moderate UC and moderate to severe CD. This was an open-label safety extension trial of an earlier placebo-controlled, PK/PD/safety study. Upon completing the antecedent study, 38 UC patients (rollovers) were randomized to a loading regimen of vedolizumab 2, 6 or 10 mg/kg on Days 1, 15 and 43, followed by maintenance dosing every 8 weeks. 15 and 19 vedolizumab-naïve subjects with UC and CD, respectively, were randomized to vedolizumab 2, 6 or 10 mg/kg dosed on the same schedule. Subjects were treated for ≤21 months. Eligible subjects were 18-75 years old with partial Mayo scores (PMS) of 0-7 (UC) or CDAI of 220-450. (Vedolizumab-naïve subjects had PMS of 2-7.) Permitted concomitant medications included 5-ASA, prednisone (≤30 mg/day) and AZA/6-MP (CD patients only). Once the 10 mg/kg dose was eliminated by protocol amendment 5.5 weeks after study start, most subjects were reassigned to 2 or 6 mg/kg for the duration of the study. Safety, efficacy (partial Mayo scores, CDAI, IBDQ), and laboratory parameters (including serum JC virus testing) were assessed on Days 1, 43, 99, 155, 267, 379, 491 and 637. At study completion, subjects were eligible to continue to receive vedolizumab in a long-term phase 3 safety extension trial.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".