Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review.

Ustekinumab is not recommended for the treatment of children with inflammatory bowel disease, but its off-label use is increasing despite a lack of pediatric pharmacokinetic data. The purpose of this review is to evaluate the therapeutic effects of Ustekinumab on children with inflammatory bowel disease and to recommend the best treatment regimen. Ustekinumab was the first biological treatment for a 10-year-old Syrian boy with steroid-refractory pancolitis who weighed 34 kg. A 260 mg/kg (~6 mg/kg) intravenous dose was followed by 90 mg of subcutaneous Ustekinumab at week 8 (induction). The patient was supposed to receive the first maintenance dose after twelve weeks, but after ten weeks, he developed acute severe ulcerative colitis which was managed according to treatment guidelines, except receiving 90 mg of subcutaneous Ustekinumab when he was discharged. The maintenance dose of 90 mg subcutaneous Ustekinumab was intensified to every 8 weeks. Throughout the treatment period, he achieved and maintained clinical remission. In pediatric inflammatory bowel disease, a dose of intravenous ~6 mg/kg of Ustekinumab is a common induction regimen, while children weighing < 40 kg may require a dose of 9 mg/kg. For maintenance, children may require 90 mg of subcutaneous Ustekinumab every 8 weeks. The outcome of this case report is interesting with improved clinical remission and highlighting the expansion of clinical trials on Ustekinumab for children.