N24 Experience with Ustekinumab (STELARA®) in Paediatric inflammatory bowel disease (pIBD) – A case series

Abstract

Background: Ustekinumab (UST) is a monoclonal antibody against IL 12/23 and is thought to drive inflammation in psoriasis and gastrointestinal inflammation. Two phase 2b studies have shown that UST induces and maintains clinical response in Crohn's disease (CD). Data of the effectiveness of UST in pIBD are lacking. Method(s): The aim of the study was to evaluate effectiveness and safety of UST as a treatment for pIBD after failure of anti-TNFa and Vedolizumab. Methods Retrospective study of demographic characteristics, medical history, dosage and schedule of UST administration, as well as data on pre and post ESR, calprotectin and PCDAI. Result(s): A total of 5 patients on UST were identified, age range 8-15 years, median 12 years, age at diagnosis 2-10 years, median 5 years, 3 males. Crohns n = 4 and UC n = 1, followed up for up to 15 months following initiation of treatment. All 5 patients had previously failed at least two biologic treatments. All 5 patients received UST 8 weekly at IV - Single, initial dose of 6 mg/kg, as intravenous infusion over at least 60 min. SC - Subsequent doses. The first subcutaneous dose of 90 mg if >40 kg and 45 mg < 40 kg. In 4/5 patients UST significantly reduced ESR, 4/5 significantly reduced calprotectin and all improved PCDAI and PGA scores. planner.smart-abstract.com/ecco2019/submission/en/abstract/13317/content# Conclusion(s): Ustekinumab seems to be effective and safe treatment in pIBD patients with no reported adverse events. We suggest multi-centre prospective Paediatric studies to advance knowledge and improve patient outcomes. (Table Presented) .