[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: K Minden, J Klotsche, M Niewerth, G Horneff, A Zink
• Journal: Zeitschrift fur Rheumatologie (Z Rheumatol) Vol. 72 Issue 4 Pg. 339-46 (May 2013) ISSN: 1435-1250 [Electronic] Germany
• Vernacular Title: Biologikaregister JuMBO. Langzeitsicherheit von Biologikatherapie bei juveniler idiopathischer Arthritis.
• PMID: 23456365 (Publication Type: English Abstract, Journal Article)

Chemical References

• Antirheumatic Agents
• Biological Products
• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Etanercept

Topics

• Antirheumatic Agents (therapeutic use)
• Arthritis, Juvenile (drug therapy, epidemiology)
• Biological Products (therapeutic use)
• Comorbidity
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Etanercept
• Female
• Germany (epidemiology)
• Humans
• Immunoglobulin G (therapeutic use)
• Male
• Prevalence
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Registries (statistics & numerical data)
• Risk Factors
• Treatment Outcome
• Young Adult