Experience with vedolizumab in children and adolescents with inflammatory bowel disease: a monocenter study
Authors:   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Potapov A.S. ,   I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation, Movsisyan G.B. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Fisenko A.P. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Vinokurova A.V. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Parakhina D.V. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Anushenko A.O. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Usoltseva O.V. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation, Tsvetkova V.S. ,   National Medical Research Center for Children’s Health, Moscow, Russian Federation
Published: February 2024

Objective. To evaluate the efficacy and safety of vedolizumab in children with inflammatory bowel disease (IBD) and to supplement existing data on experience with its use in pediatric patients. Patients and methods. The efficacy of vedolizumab therapy in children with IBD was assessed by analyzing observational data of 37 patients aged 6 to 17 years (29 children with ulcerative colitis (UC), 8 children with Crohn’s disease (CD)) for the period 2019–2023. The mean age at initiation of therapy was 13 years. Prior treatment in all patients included the use of anti-TNF (tumor necrosis factor) agents. Clinical and endoscopic indices of disease activity, anthropometric and laboratory characteristics at 0–14–26–52 weeks for UC and 0–52 weeks for CD were recorded. Results. During one year of therapy, 29 patients with UC whose mean age at initiation of vedolizumab was 12.3 years and who had a history of anti-TNF therapy (100% infliximab, 48.3% adalimumab) achieved a significant improvement in PUCAI and UCEIS scores, normalization of hemoglobin and iron concentrations, regression of thrombocytosis, and a decrease in calprotectin levels; there was also a reduction in the number of patients with a BMI-for-age and length-for-age Z-scores <2. Eight patients with CD whose mean age at initiation of vedolizumab was 14.8 years and who had a history of anti-TNF therapy (62.5% infliximab, 75% adalimumab) achieved a statistically significant improvement in PCDAI and SES-CD scores, resolution of thrombocytosis, increasing hemoglobin and iron concentrations, and decreasing calprotectin levels 52 weeks after therapy initiation. In the group of patients receiving prednisolone at the time of therapy initiation, 50% of children with UC achieved steroid-free remission by week 14, while 28.5% and 60% of children with UC and CD, respectively, achieved remission by week 52. Clinical remission was established by week 14 in 16/29 (55.2%) children with UC (of whom 31% did not receive steroids), by week 52 in 20/29 (68%) children with UC and in 4/8 (50%) with CD. Conclusion. Vedolizumab demonstrated its efficacy and safety for successful use in pediatric patients with IBD. Within a year, most children with UC and CD showed improvement in anthropometric, clinical, laboratory, and endoscopic parameters. Key words: children, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, biologic therapy, vedolizuma