P382 High anti-tumor necrosis factor alpha treatment trough concentrations are not associated with higher rate of adverse events in pediatric patients with inflammatory bowel disease

Zvuloni, M.(1);Matar, M.(2);Levi, R.(3);Shamir, R.(1,2);Assa, A.(2,4);

(1)The Sackler Faculty of Medicine- Tel Aviv University- Israel, Medicine department, Tel Aviv, Israel;(2)Schneider Children's Hospital, The institute of Gastroenterology- Nutrition and Liver diseases, Petach-Tikva, Israel;(3)Schneider Children's Hospital, Pediatric department A, Petach-Tikva, Israel;(4)The Ben-Gurion University of the Negev-- Israel, Medicine department, Beer Sheva, Israel


Anti-tumor necrosis factor alpha (anti-TNFα) therapy is commonly used to treat refractory pediatric inflammatory bowel disease (IBD). Prolonged use of anti-TNFα therapy has been linked to a number of adverse events. We aimed to assess the relationship between serum trough concentrations (TC) of anti-TNFα and adverse events rate among patients with pediatric IBD.


The medical records of 135 pediatric patients with IBD who were treated with anti-TNFα agents from 2015 to 2020 and had sequential monitoring of TC were reviewed retrospectively for the presence of adverse events (infusion reactions, infections, acute cutaneous reactions, psoriatiform rashes, elevated transaminases and others). The association between demographic or disease related variables and adverse events were analyzed using multivariate analysis.


Out of 135 patients, [59 (43.7%) female, mean age at diagnosis 12.9 (±3)years, 111 (82.2%) Crohn’s disease] who had 1645 measurements of TC [1037(63%) infliximab, range 0-46 µgr/ml] during a median follow-up period of 1.7 years (1.1-2.7), we recorded 120 adverse events in 42 patients (31%). When analyzing TC as continuous measure or as a categorical measure (> or <10 µgr/ml) there were not associated with a higher rate of adverse events (p=0.9).Patients who reported non-infusion related adverse events were younger at the time of diagnosis (mean age 11.4±3.9 vs.13.3±2.8years) than those without adverse effect (p=0.029). There was no statistically significant correlation between other variables (gender, disease type, Paris classification, extra-intestinal manifestation, perianal disease, and the pediatric disease activity index) and the occurrence of adverse events.


Based on our cohort, higher TCs were not associated with higher rate of anti-TNF related adverse events whereas younger age at diagnosis increased the risk for such events. The study protocol was approved by the local Internal Review Board at the Rabin/Schneider Medical Center (RMC0320-10).