Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7
integrin which modulates lymphocyte trafficking in the gut.
Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in
induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease
(CD), respectively.
Recent real life cohorts in adults support the effectiveness of VDZ in inducing and
maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the
use of VDZ besides two retrospective case series.
Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults
and practically non-existent in children.
The investigators aim to prospectively explore the real life short and longer term outcomes
of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment
success based on VDZ trough levels and other clinical and laboratory variables.