E42 Severe infectious adverse events in children treated with biological agents

Abstract Background Since the 90’s, biologics, as a novel class of drugs, have revolutionized the therapeutic field of autoimmune and inflammatory diseases in children by providing effective treatment options. Biologics aim to modify targeted pathways to interfere with the immunologic aberration creating the clinical disease, However, alteration of the pathways increase the risk of infection. We report a series of severe infectious adverse events (SIAE) in children treated with biologics. Objectives and Methods This is a retrospective study over a period of 10 years (January 2012-October 2022) conducted in the Department of Pediatric Rheumatology and internal Medicine, A. Harouchi Mother and Child Hospital CHU Ibn Rochd, Casablanca, Morocco. The aim of our study is to assess SIAE in children treated with Results The study included 76 patients on biologics with different diseases dominated by systemic juvenile idiopathic arthritis. Six patients developed SIAE, sex-ratio was 1, four patients received TNF-alpha inhibitors (Infliximab, Adalimumab, Etanercept), 1 on Tocilizumab and 1 on Rituximab. Our 6 patients were on other immunosuppressive agents simultaneously (Corticosteroids, MMF, Azathioprine, Methotrexate). The delay of occurrence of SIAE after the initiation of biologics ranged from 10 days to 7 years. We report 3 cases of Tuberculosis, 2 of which were treated with anti-TNF agents, 1 case of CMV hepatitis, 1 case of Herpes zoster and 1 case of orbital cellulites. Treatment consisted of temporary discontinuation of biologic with specific management of the SIAE by an appropriate anti-infectious agent. The evolution was favorable except one case of death. Discussion and Conclusion Biologics have become an important component of effective management of patients with autoimmune and inflammatory diseases. However, there is an increased risk of SIAE for those patients, especially the risks of Tuberculosis and viral infections, even though systematic screening is performed prior to the start of biotherapy, requiring physician vigilance.