AB0961 ADVERSE EVENTS ASSOCIATED WITH ANTI-TNF-ALPHA THERAPY IN PEDIATRIC RHEUMATIC DISEASES. (June 2019)

• Record Type: Journal Article
• Authors: Sözeri, Betül; Demir, Ferhat; çakır, Deniz; Ciftci, Fatma; Kurtulus, Duygu
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 1947
• Page End: 1947
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.7935
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: In recent years, the biologic drugs has led to a dramatic change in the management of rheumatic diseases. The most commonly used molecules are TNF-α antagonists among biologic treatments in pediatric age (1). The anti-TNF-α agents used in childhood are; etanercept (a fusion protein of the TNF-α receptor), infliximab (a chimeric monoclonal antibody) and adalimumab (completely human monoclonal antibody). As a result of the increasing use of anti-TNF-α agents in recent years, adverse events reports have also increased (2). We assessed the prevalence of adverse events (AEs) in a single pediatric referral center for chronic rheumatic diseases. Objectives: The aim of this study was to evaluate the adverse events that associated with anti-TNF-α therapy in children with rheumatic disease. Methods: This was cross-sectional study conducted University of Health Sciences, Umraniye Training and Research Hospital, Department of Pediatric Rheumatology, in Turkey. We retrospectively reviewed the patients with a diagnosis any of pediatric rheumatic disease whom treated at least 3 months with an anti-TNF-alpha agents (etanercept, infliximab, adalimumab), between June 2016 and January 2019. Adverse events that develop after anti-TNF-α treatment were recorded. AEs were categorized and graded based on the Common Terminology criteria for AEs (CTCAE). Grades 3-5 were considered severe AEs. Results: We evaluated 131 patients who were treated with anti-TNF-a drugs; 110 with juvenile idiopathic arthritis (JIA)(27 of with uveitis) 83%, 10 with idiopathic uveitis 7%, 5 with Behçet's uveitis%4, 4 with adenosine deaminase deficiency%3, and 2 with juvenile sarcoidosis%2. The study included 74 females and 57 males (F/M: 1.29/1) and the mean age of the patients was 12.8 years. Of the patients, 106 had used only 1, 21 had two different and 4 had 3 different anti-TNF-alpha biologic treatments. A total of 160 different anti-TNF-alpha experiences had in 131 patients. A total of 333.4 patient-years (PYs) were included: 136 PYs-63 patients for etanercept (2.15 patient/year), 134 PYs-68 patients for adalimumab (1.97 p/y) and 63.4 PYs- 29 patients for infliximab (2.18 p/y). During follow-up, 44 patients (33.5%) experienced at least one AEs. 14 of them (10%) were recorded as SAEs. 17 of the AEs were show up after adalimumab, 16 were etanercept and 11 were infliximab. The most common AEs were found; local reactions, increased infection frequency and PPD positivity in follow up, respectively. The SAEs that observed were; anaphylactoid reactions (n=5), uveitis (n=3), pneumonia (n=3), TAILS (n = 2) and vasculitis (n=1). Conclusion: Here in, we presented safety data of anti-TNF-alpha drugs in pediatric patients. Although the high prevalence of AEs was observed, when anti-TNF-a discontinuation, AEs were mostly not persistent and not mortal. References: [1] Vanoni F, Minoia F, Malattia C. Biologics in juvenile idiopathic arthritis: a narrative review. Eur J Pediatr. 2017;176:1147-53. [2] Pastore S, Naviglio S, Canuto A, Lepore L, Martelossi S, Ventura A, Taddio A. Serious Adverse Events Associated with Anti-Tumor Necrosis Factor Alpha Agents in Pediatric-Onset Inflammatory Bowel Disease and Juvenile Idiopathic Arthritis in A Real-Life Setting. Paediatr Drugs. 2018;20:165-71. Acknowledgement: We are grateful to all participating children and their families. Ethics committee approval was received from the Institutional Review Board of Umraniye Training and Research Hospital. All the participants and their legal guardians were informed, and their written consent was obtained. Disclosure of Interest: None Declared Disclosure of Interests: None declared