Background
Vedolizumab is increasingly used off-label to treat children and adolescents with inflammatory bowel disease (IBD). In the absence of rigorous clinical trial experience, multicenter observational data are important to establish expectations for efficacy and safety. We examined one-year outcomes following vedolizumab therapy in a large multicenter paediatric IBD cohort.
Methods
We performed a retrospective study of 159 paediatric patients (4-17 years old) with IBD (78, Crohn disease [CD]; 81, ulcerative colitis/IBD-unspecified [UC/IBD-U]) treated with vedolizumab for 1-year at 8 paediatric medical centers in the United States. Demographics, clinical outcomes, laboratory data, and vedolizumab dosing were recorded. The primary outcome was corticosteroid free clinical remission at 1-year. Other measured outcomes were clinical remission at 12-weeks and/or 24 weeks, laboratory outcomes at 1 year, and endoscopy/histology results at 1 year.
Results
Among the 159 patients (mean age, 14.5±2.4 y; 86% anti-TNF experienced), 68/159 (43%) achieved corticosteroid free clinical remission at 1 year (CD 35/78, 45%; UC/IBD-U 33/81, 40%). Vedolizumab therapy failed and was discontinued in 33/159 (21%) patients prior to 1-year (CD, 18/78, 23%; UC/IBD-U, 15/81, 19%). While Week 12 clinical remission was not predictive of 1-year clinical remission in either CD or UC/IBD-U, week 24 clinical remission was predictive of 1-year clinical remission only in CD patients. No infusion reactions or serious side effects were noted.
Conclusion
Vedolizumab was safe and effective in this paediatric population with approximately 43% achieving corticosteroid free clinical remission at 1-year. Similar efficacy was noted in both CD and UC.
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