The safety of vedolizumab for ulcerative colitis and Crohn's disease

JF Colombel, BE Sands, P Rutgeerts, W Sandborn… - Gut, 2017 - gut.bmj.com
… (PYs) of exposure. … of vedolizumab exposure (median exposure range, 1–1977 days). No
increased risk of any infection or serious infection was associated with vedolizumab exposure. …

Systematic review: the safety of vedolizumab for the treatment of inflammatory bowel disease

WA Bye, V Jairath, SPL Travis - Alimentary pharmacology & …, 2017 - Wiley Online Library
… Higher, but statistically insignificant rates of enteric infections occurred in vedolizumab-exposed
patients (7.4/100 PYs; 95% CI: 6.6-8.3) compared to placebo (6.7 PYs; 95% CI: 3.2-10.1)…

Vedolizumab exposure in pregnancy: outcomes from clinical studies in inflammatory bowel disease

U Mahadevan, S Vermeire, K Lasch… - Alimentary …, 2017 - Wiley Online Library
… active Crohn's disease (CD) and ulcerative colitis (UC), based on clinical trials with exposure
… do not associate vedolizumab exposure during pregnancy with any new safety concerns. …

Exposure–efficacy relationships for vedolizumab induction therapy in patients with ulcerative colitis or Crohn's disease

M Rosario, JL French, NL Dirks… - Journal of Crohn's …, 2017 - academic.oup.com
ulcerative colitis [UC] or Crohn’s disease [CD]. The mechanism of action of vedolizumab
differs from that of other marketed biologics for the treatment of inflammatory bowel disease […

Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation

MT Osterman, M Rosario, K Lasch… - Alimentary …, 2019 - Wiley Online Library
Ulcerative colitis (UC) and Crohn's disease (CD) are chronic idiopathic inflammatory
bowel diseases (IBDs) for which no medical cure presently exists. Patients with moderate-to-severe …

… observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease …

N Vande Casteele, WJ Sandborn… - Alimentary …, 2022 - Wiley Online Library
… of the study was to evaluate vedolizumab exposure–response … vedolizumab therapy,
delineate vedolizumab exposure … relationship between vedolizumab exposure and response …

Long‐term safety of vedolizumab for inflammatory bowel disease

EV Loftus Jr, BG Feagan, R Panaccione… - Alimentary …, 2020 - Wiley Online Library
… However, in GEMINI LTS, vedolizumab was associated with lower rates of colon and rectal
… Although this analysis includes longer cumulative exposure to vedolizumab, the rate of …

Exposure–efficacy relationship of vedolizumab subcutaneous and intravenous formulations in Crohn's disease and ulcerative colitis

G D'Haens, M Rosario, D Polhamus… - Expert Review of …, 2024 - Taylor & Francis
… critical to achieving optimal treatment outcomes in inflammatory bowel diseases [Citation7]. …
This study characterized vedolizumab exposure−efficacy during the maintenance phase of …

Systematic review and meta-analysis: vedolizumab and postoperative complications in inflammatory bowel disease

DE Yung, N Horesh, AL Lightner… - … bowel diseases, 2018 - academic.oup.com
… Several studies have reported the surgical outcomes of inflammatory bowel disease (IBD)
patients exposed to vedolizumab (VDZ) preoperatively, with conflicting results. This meta-…

Tissue exposure does not explain non-response in ulcerative colitis patients with adequate serum vedolizumab concentrations

N Van den Berghe, B Verstockt, A Gils… - Journal of Crohn's …, 2021 - academic.oup.com
… do not respond to vedolizumab treatment despite sufficient drug exposure in the blood … ,
we investigated vedolizumab tissue exposure and explored whether insufficient tissue exposure