Real‐world multicentre observational study including population pharmacokinetic modelling to evaluate the exposure–response relationship of vedolizumab in inflammatory bowel disease: ERELATE Study

• DOI: 10.1111/apt.16937
• Publication Date: 2022-04-27T08:29:50Z
• Authors: Niels Vande Casteele; William J. Sandborn; Brian G. Feagan; Séverine Vermeire; Parambir S. Dulai; Andres Yarur; Xavier Roblin; Shomron Ben‐Horin; Iris Dotan; Mark T. Osterman; Maria Rosario; Teresa McRorie Os...; Julian Panes; Dirk Lindner; Christian Agboton
• Keywords: Vedolizumab; Faecal calprotectin

Summary Background ERELATE was a phase 4, multinational, retrospective, observational study. Aim To evaluate the relationship between intravenous vedolizumab exposure and treatment outcomes over 52 weeks in adults with ulcerative colitis (UC) or Crohn’s disease (CD). Methods Real‐world data from patients UC CD treated nine centres six countries were collected retrospectively. Treatment at Weeks 14, 26 52. An established population pharmacokinetic model (incorporating observed concentrations based on Bayesian approach) used to predict individual exposure. Vedolizumab exposure–response evaluated overall, by indication baseline characteristics. Results The study ( n = 695; UC, 304; CD, 391) had median age of 39 years; 47.9% male 86.9% prior tumour necrosis factor antagonist By Week clinical, endoscopic, deep (clinical plus endoscopic) biologic remission achieved 47.3%, 59.6%, 30.7% 19.0% respectively. Higher trough concentration early consistently associated clinical later time points. Clinical 14 6 ≥31.0 ≥32.0 μg/ml Importantly, multivariable analysis identified clearance as only measure predictive Conclusions In this real‐world study, positive for vedolizumab. during induction may be an important predictor short‐ long‐term outcomes, similarly, remission.