Safety of biological agents in paediatric rheumatic diseases: A real-life multicenter retrospective study using the JIRcohorte database

• Published in: Joint, bone, spine : revue du rhumatisme bone, spine : revue du rhumatisme, 2019-05, Vol.86 (3), p.343-350
• Main Authors: Cabrera, Natalia, Lega, Jean-Christophe, Kassai, Behrouz, Wouters, Carine, Kondi, Anuela, Cannizzaro, Elvira, Woerner, Andreas, Chausset, Aurelie, Roethlisberger, Samuel, Jeanneret, Cyril, Aeschlimann, Florence, Malik, Salma, Duquesne, Agnès, Kaiser, Daniela, Higel, Laetitia, Maes, Anne, Berthet, Gerald, Hentgen, Veronique, Kone-Paut, Isabelle, Belot, Alexandre, Hofer, Michael
• Format: Article
• Language: English
• Subjects: Abatacept - adverse effects; Abatacept - therapeutic use; Adolescent; Adverse events; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antirheumatic Agents - therapeutic use; Arthritis, Juvenile - diagnosis; Arthritis, Juvenile - drug therapy; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Biological agents; Biological Factors - therapeutic use; Child; Child, Preschool; Cohort Studies; Databases, Factual; Etanercept - adverse effects; Etanercept - therapeutic use; Female; Humans; Infliximab - adverse effects; Infliximab - therapeutic use; Internationality; JIRcohorte; Juvenile idiopathic arthritis; Kaplan-Meier Estimate; Life Sciences; Male; Multivariate Analysis; Paediatric rheumatology; Pain Measurement - drug effects; Prognosis; Proportional Hazards Models; Range of Motion, Articular - drug effects; Retrospective Studies; Risk Assessment; Serious adverse events; Treatment Outcome
• ISSN: 1297-319X; 1778-7254
• DOI: 10.1016/j.jbspin.2018.08.003

•The overall safety of biological agents (BAs) in paediatric rheumatology practice is acceptable in real life.•The combination of immunosuppressive drugs with BAs may contribute to side effects and a cautious follow-up should be considered in this setting.•Varicella-zoster virus represents the main (preventable) infection under treatment. To analyse and report the incidence of side effects of biological agents in paediatric patients with inflammatory diseases using of real-life follow-up cohort. In this international, observational, retrospective, multicentre study of children treated by biological agents and followed in the Juvenile Inflammatory Rheumatism (JIR) cohort (JIRcohorte) network, a Kaplan–Meier method was used to estimate the occurrence of adverse events. A Cox model was constructed to identify independent predictors of adverse events. Overall 813 patients totalling 3439 patients–year (PY) of biological agents were included. The main diagnosis was juvenile idiopathic arthritis (84%). A total of 222 patients (27.3%) had 419 adverse events, representing an incidence rate of 12.2 per 100 PY 95% CI [11.0; 13.4]. The overall incidence rate of serious adverse events was 3.9 per 100 PY 95% CI [3.2; 4.6]. Tocilizumab and infliximab were significantly associated with adverse events and canakinumab with serious adverse events. Univariate and multivariable analysis of adverse events and serious adverse events indicated that patients under biological agents with concomitant immunosuppressive drugs (excluding methotrexate) suffered from more of these events. This study suggests an overall an acceptable safety of biologic agents in children with inflammatory rheumatic diseases treated with biological agents. However, the concomitant prescription of immunosuppressive drugs with biological agents represents a substantial risk of adverse events.