Safety and efficacy of vedolizumab in pediatric inflammatory bowel disease with emphasis on the very-early-onset group

Introduction: Vedolizumab (VDZ) is effective in the induction and maintenance of remission in adults with inflammatory bowel disease (IBD). Pediatric data are still limited. This retrospective cohort study aimed to assess the safety and efficacy of VDZ in pediatric IBD including very-early-onset IBD (VEO-IBD). Material and methods: A review of pediatric IBD patients receiving VDZ was conducted. Laboratory parameters, nutritional status, and disease activity scores were compared between each follow-up visit and between two groups divided by age of disease onset – VEO-IBD (age of onset < 6-years-old) and non-VEO-IBD (age of onset ≥ 6 years < 17 years). The primary outcome was clinical response after induction therapy (at 4 th dose visit). The secondary outcome was clinical remission after induction (at 4th dose visit) and maintenance phase (at 10th dose visit). Statistical considerations were included. Results: Seventy-two patients with pediatric IBD were included: 12 with Crohn disease (CD), 60 with ulcerative colitis (UC). The definition of VEO-IBD was met by 21 patients. After the induction phase, a clinical response was observed in 60/72 (83.3%) patients (51/60 with UC and 9/12 with CD) and clinical remission in 44/72 (61.1%) patients (40/60 with UC and 4/12 with CD). Clinical remission after the maintenance phase was achieved by 22/72 (30.6%) patients (16/60 with UC and 6/12 with CD). Improvement in the patients’ laboratory parameters and nutritional status was observed. No significant differences were observed in VDZ response between VEO-IBD and non-VEO-IBD. Conclusions: Vedolizumab was safe and effective in the treatment of pediatric IBD irrespective of age of disease onset.