P1130 Predictors of Remission within One Year of Advanced Therapy in Paediatric Patients with Ulcerative Colitis – analysis from Czech national registry of biologic treatment (CREdIT)

Abstract

Abstract Background Data on the outcomes of advanced therapy in paediatric patients with ulcerative colitis (UC) and their predictors are scarce. We aim to assess the association between remission at one year of treatment and pre-specified predictors, including types of advanced therapy. Methods Using the Czech national prospective registry of biologic and innovative therapy of IBD (CREdIT), we identified 207 courses of treatment among paediatric UC patients. Disease remission was defined as Paediatric Ulcerative Colitis Index below 10 points. In this preliminary analysis, we employed mixed-effects regression models to attempt to identify an association between pre-specified predictors (duration of disease, first-line treatment, baseline age, baseline PUCAI, extension, ever severe, indication, baseline immunomodulator, drug) and remission at one year of the treatment. A patient, biologic center, and a time period were added as random effects into the models. Results Among 132 observations (60 female, 46%) in 108 patients, 85 were with infliximab (64%), 22 with adalimumab (17%), 20 with vedolizumab (15%), 4 with ustekinumab (3%) and 1 with tofacitinib. Most of the observations were from the first line of the biologic treatment (first: 95, 72%, second: 27, 21%, third: 7, 5.3%) and with concomitant immunosuppressive therapy at the beginning of the treatment course (97, 74%). Irrespective of treatment line, remission at 1 year was achieved in 53% (45/85) of infliximab, 36% (8/22) of adalimumab, 60% of vedolizumab and 50% of ustekinumab (2/4) treatment courses. However, we did not find a difference between the individual preparations in either the unadjusted mixed model or multiple mixed regression model. Of the pre-specified predictors, only longer duration of disease to the start of the therapy course was weakly associated with a lower remission rate in the treatment year when adjusted for treatment line (OR 1.16, 95%CI 1.00-1.34). In a sub-analysis of first-line advanced therapy only, 53% (44/83) of infliximab courses and 55% (6/11) of adalimumab courses achieved clinical remission at 1 year. Using a regression mixed model, we did not find any difference between treatment outcomes with these agents. Conclusion Based on data from real paediatric clinical practice, only half of patients with UC achieve clinical remission within a year of initiation of advanced therapy. This shows how important is to expand the drug armamentarium also in the paediatric population. Our study shows that time to initiation of advanced therapy may be an important factor even in patients with UC. Support The Grant Agency of Charles University in Prague (227023) and the Ministry of Health, Czech Republic, for the conceptual development of the research organisations (00064203).