Safety of biological agents in paediatric rheumatic diseases: A real-life multicenter retrospective study using the JIRcohorte database |
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| Affiliation: | 1. UMR CNRS 5558, Laboratoire de Biométrie et Biologie Humaine, Équipe Évaluation et Modélisation des Effets Thérapeutiques, rue Guillaume-Paradin, BP8071, 69376 Lyon cedex 08, France;2. Inserm U1111, National Referral Centre for rare Juvenile Rheumatological and Auto-immune Diseases (RAISE), Department of Paediatric Rheumatology, Lyon University Hospital, University of Lyon, 69677 Bron cedex, France;3. National Referral Centre for rare Juvenile Rheumatological and Auto-immune Diseases (RAISE), Department of Internal and Vascular Medicine, Hôpital Lyon Sud, Lyon University Hospital, University of Lyon, 69495 Pierre-Bénite, France;4. Clinical Investigation Center (CIC1407), Lyon University Hospital, 69003 Lyon, France;5. Department of Paediatrics, University Hospitals Leuven, Leuven, Belgium;6. Department of Immunology and Microbiology, Childhood Immunology, University of Leuven, 3000 Leuven, Belgium;7. Department of Paediatrics and Paediatric Rheumatology, Centre de référence des maladies auto-inflammatoires rares et de l''amylose inflammatoire (CEREMAIA), Bicêtre University, Paris Sud Hospital, 94270 Le Kremlin-Bicêtre, France;8. University Children''s Hospital, 8032 Zürich, Switzerland;9. Paediatric Rheumatology, University of Basel, University Children''s Hospital, 4031 Basel, Switzerland;10. Department of Paediatrics, Estaing Hospital, Clermont-Ferrand University Hospital, 63100 Clermont-Ferrand, France;11. Paediatric Rheumatology Western Switzerland, Centre Hospitalier Universitaire vaudois (CHUV) 1011 Lausanne and Hospital Universitaire Genève (HUG) 1206 Geneva, Switzerland;12. Department of Paediatrics, Hospital of Lucerne, 6000 Lucerne, Switzerland;13. Hautepierre Hospital, University Hospitals Strasbourg, 67200 Strasbourg, France;14. Department of Paediatrics, Hospital of Aarau, 5001 Aarau, Switzerland;15. Centre de référence des maladies auto-inflammatoires rares et de l''amylose inflammatoire (CEREMAIA), Versailles University Hospital, 78157 Le Chesnay, France;1. Department of Rheumatology, Dijon University Hospital, University of Burgundy, 14, rue Paul Gaffarel, 21000 Dijon, France;2. Department of Infectious Disease, Dijon University Hospital, University of Burgundy, 14, rue Paul Gaffarel, 21000 Dijon, France;3. Neurologist, Dijon, 21, boulevard De Brosse, 21000 Dijon, France;4. Department of Microbiology, Dijon University Hospital, University of Burgundy, 14, rue Paul Gaffarel, 21000 Dijon, France;1. EA 7408, University Grenoble Alpes, GREPI, 38400 Saint-Martin-d’Hères, France;2. Rheumatology Department, centre hospitalier universitaire Grenoble Alpes, hôpital Sud Echirolles, 38130 Echirolles, France;3. Pôle biologie, hôpital Michallon, centre hospitalier universitaire Grenoble Alpes, 38700 La Tronche, France;4. Department of Rheumatology, Saint-Etienne University Hospital, 42270 Saint-Etienne, France;5. Inserm 1059, SAINBIOSE University of Saint-Etienne, 42270 Saint-Etienne, France;6. Service de rhumatologie, hôpital G.-Montpied, centre hospitalier universitaire Clermont-Ferrand, 63003 Clermont-Ferrand, France;7. Department of Immunology and Rheumatology, Immunogenomics and Inflammation Research Unit EA 4130, University of Lyon, Edouard Herriot Hospital, 69003 Lyon, France;8. Rheumatology Department, centre hospitalier Lyon-Sud, 69310 Pierre-Bénite, France;9. TIMC-IMAG Laboratory UMR 5525, CNRS, université Grenoble Alpes, 38041 Grenoble, France;10. Inserm CIC/CRB1404, Normandie Univ, UNIROUEN, Inserm U 1234, Rouen University Hospital, Department of Rheumatology, 76031 Rouen cedex, France;11. Sinnovial, 38000 Grenoble, France;1. Service de Chirurgie Orthopédique et Traumatologie, CHU Pontchaillou, 2, rue Henri-Le-Guilloux, 35000 Rennes, France;2. Université Rennes-1, 35033 Rennes, France |
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| Abstract: | ObjectiveTo analyse and report the incidence of side effects of biological agents in paediatric patients with inflammatory diseases using of real-life follow-up cohort.MethodsIn 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.ResultsOverall 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.ConclusionThis 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. |
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| Keywords: | Biological agents Paediatric rheumatology Juvenile idiopathic arthritis Adverse events Serious adverse events JIRcohorte |
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