title: [Biologics register JuMBO. Long-term safety of biologic therapy of juvenile idiopathic arthritis].
abstract: In recent years the treatment of juvenile idiopathic arthritis (JIA) has changed dramatically. Nowadays one out of three children with polyarticular JIA is treated with a biologic drug; however, knowledge about the long-term safety of biologics is still limited. Information on drug safety is collected in the JIA biologic register (BiKeR) and the follow-up register juvenile arthritis methotrexate/biologics long-term observation (JuMBO). The latter currently includes information on more than 700 young adults most of whom were treated with etanercept and prospectively followed for more than 5 years. Preliminary data on the long-term safety of etanercept for JIA are therefore available. Over an observation period of 1,800 etanercept exposure-years, events of particular interest, such as malignancies, serious infections and new onset immune-mediated diseases have been recorded which occurred at rates of 0.1, 1.1 and 0.9/100 patient-years, respectively. Overall, new safety risks were not detected during long-term etanercept exposure. Moreover, JuMBO has also provided information on the long-term outcome of JIA and initial evidence suggests that JIA outcome, especially in functional aspects has improved in the biologic era. Data from BiKeR and JuMBO contribute to the risk-benefit assessment of biologic drugs which have been implemented in the routine treatment of JIA.
authors: Deutsches Rheuma-Forschungszentrum Berlin, ein Institut der Leibnizgemeinschaft, Programmbereich Epidemiologie, Charitéplatz 1, 10117 Berlin. minden@drfz.de
authors: K
authors: K
authors: Minden
authors: J
authors: J
authors: Klotsche
authors: M
authors: M
authors: Niewerth
authors: G
authors: G
authors: Horneff
authors: A
authors: A
authors: Zink
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000453:epidemiology*; D001688:Biological Products / Q000627:therapeutic use; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D000068800:Etanercept; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D015995:Prevalence; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012042:Registries / Q000706:statistics & numerical data*; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept