P369 Dual Biologic in Moderate to Severe Pediatric Inflammatory Bowel Disease: A Case Series

Abstract

Abstract Background Inflammatory bowel diseases (IBD) patients equipped in biological therapy embody a group with significant disease burden who have never succeeded conventional medication such as corticosteroids and thiopurines. Biologic agents are frequently used in the disease course, however they only result in, 1-year remission rates of approximately, 40% in given IBD populations. We aim to assess the efficacy and safety of concomitant use of, 2 biologic therapies including: anti-TNF (infliksimab, adalimumab) vedolizumab and ustekinumab in a refractory pediatric IBD cohort. Methods Eight children (5 ulcerative colitis, 1 ulcerative colitis/IBD-unspecified, 2 Crohn’s disease) with a disease duration of, 3,2 (8mth-9 years), initiated dual therapy at an age of, 10,8 (3–17) years after failing ≥2 biologic therapies. Three (37,5%) were treated with ustekinumab/adalimumab, 3 (37,5%) with vedolizumab/adalimumab and, 2 (25%) with infliksimab/vedolizumab. Primary outcome was clinical response after minimum, 3 dose of a second biological drug. It was defined as a decrease in PCDAI of at least, 12.5 points between baseline and, 3th dose of a second biological drug for CD, and a decrease in PUCAI of at least, 20 points between baseline and this time for UC. Results A clinical improvement was obtained in seven children (87,5%;, 4 UC, 1 UC/IBD-unspecified, 2 CD) in PCDAI/PUCAI scale after minimum, 3 dose of a second biological drug. Clinical response in patients: mean baseline PCDAI score was, 58,5 ±, 9 and, 21 ±, 19 after induction therapy with second biological drug, while PUCAI score was, 62 ±, 17 vs., 29 ±, 15, respectively. We reported one adverse event during treatment in the form of an anal abscess (UC, vedolizumab/adalimumab). Conclusion In pediatric IBD, combining biological agents seems to be safe and beneficial in selected patients. The application of dual biological therapy seems to be an appealing therapeutic option and may bring a possibility to better tailor and customize the therapies for patients. In a few publications the comparative efficacy and safety endpoints of dual therapies have been provided. Nevertheless, the clarification and justification of potential advantages of combined biological therapies in further studies such as randomized control trials are needed.