Trial reportWorld journal of gastroenterology2025
Vedolizumab serum trough concentrations with and without thiopurines in ulcerative colitis: The prospective VIEWS pharmacokinetics study.
Trial report in World journal of gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Vedolizumab in inflammatory bowel disease: pharmacokinetics and the role of immunomodulator co-therapy.Therapeutic advances in gastroenterology · 2026Review
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Authors and funding
7 authors.
Funding
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Abstract
backgroundUlcerative colitis (UC) is a chronic inflammatory condition requiring continuous treatment and monitoring. There is limited pharmacokinetic data on vedolizumab during maintenance therapy and the effect of thiopurines on vedolizumab trough concentrations is unknown.
aimTo investigate the exposure-response relationship of vedolizumab and the impact of thiopurine withdrawal in UC patients who have achieved sustained clinical and endoscopic remission during maintenance therapy.
methodsThis is a post-hoc analysis of prospective randomized clinical trial (VIEWS) involving UC patients across 8 centers in Australia from 2018 to 2022. Patients in clinical and endoscopic remission were randomized to continue or withdraw thiopurine while receiving vedolizumab. We evaluated vedolizumab serum trough concentrations, presence of anti-vedolizumab antibodies, and clinical outcomes over 48 weeks to assess exposure-response association and impact of thiopurine withdrawal.
resultsThere were 62 UC participants with mean age of 43.4 years and 42% were females. All participants received vedolizumab as maintenance therapy with 67.7% withdrew thiopurine. Vedolizumab serum trough concentrations remained stable over 48 weeks regardless of thiopurine use, with no anti-vedolizumab antibodies detected. Patients with clinical remission had higher trough concentrations at week 48. In quartile analysis, a threshold of > 11.3 μg/mL was associated with sustained clinical remission, showing a sensitivity of 82.4%, specificity of 60.0%, and an area of receiver operating characteristic of 0.71 (95%CI: 0.49-0.93). Patients discontinuing thiopurine required higher vedolizumab concentrations for achieving remission.
conclusionA positive exposure-response relationship between vedolizumab trough concentrations and UC outcomes suggests that monitoring drug levels may be beneficial. While thiopurine did not influence vedolizumab levels, its withdrawal may necessitate higher vedolizumab trough concentrations to maintain remission.
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