Anti-tumor necrosis factor therapy in Bulgarian pediatric patients with inflammatory bowel disease – an 8-year experience of a referral center

Abstract

Introduction: Anti-tumor necrosis factor (anti-TNF) therapy has become a mainstay in the treatment of patients with inflammatory bowel disease over the past few decades. Aim: The aim of this study was to present our 8-year experience with anti-TNF treatment in pediatric patients with inflammatory bowel disease. Materials and methods: We reviewed retrospectively the medical records of all children with inflammatory bowel disease who received anti-TNF drugs between September 2013 and September 2021. Results: The study included 48 patients in total, with a median age of 15 years (range: 11 months to 17 years). All but one of them were receiving combination therapy, which included both an immunomodulator and a biologic agent, for moderate-to-severe disease. Infliximab was administered to only half of the study participants, adalimumab was only received by 22.9%, and 27.1% were treated with more than one biologic agent. Clinical remission at 6 months was achieved by 72.9% of them and 47.9% achieved a deep remission at 12 months. A quarter of the patients required therapy escalation and 27.1% switched to another biologic agent due to adverse events, primary non-response, or secondary loss of response (18.8% switched to a second anti-TNF and 8.3% switched to an anti-integrin agent). During the study period, the following serious adverse drug reactions were observed: 3 cases of anaphylactic reactions, 1 case of allergic rash, 1 case of disseminated tuberculosis, 1 case of severe herpes simplex infection, 1 case of herpes zoster infection, and 2 cases of drug-induced psoriasis. Conclusions: Anti-TNF agents are an effective and safe treatment option in Bulgarian pediatric patients with inflammatory bowel disease.