Back to Search
Start Over
Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA).
- Source :
-
Annals of the rheumatic diseases [Ann Rheum Dis] 2016 May; Vol. 75 (5), pp. 855-61. Date of Electronic Publication: 2015 Apr 29. - Publication Year :
- 2016
-
Abstract
- Importance: Published evidence on the long-term safety of etanercept (ETA) and adalimumab (ADA) in patients with polyarticular juvenile idiopathic arthritis (pJIA) is still limited.<br />Objectives: To investigate the rates of serious adverse events (SAE) and of events of special interest (ESI) under ETA and ADA treatment.<br />Design, Setting and Participants: Patients with pJIA were prospectively observed in the national JIA biological register, Biologika in der Kinderrheumatologie, and its follow-up register, Juvenile arthritis Methotrexate/Biologics long-term Observation.<br />Main Outcomes and Measures: We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate (MTX).<br />Results: Among the 1414 patients treated with ETA (n=1414; 4461 exposure years (EY)) and ADA (n=320; 493 EY), significantly more SAE, infections and medically important infections were observed (ETA: 4.5, 5.7, 0.9; ADA: 4.7, 11.4, 0.4 per 100 EY) compared with those treated with MTX alone (n=1455; 2.907 EY; 2.6, 5.5, 0.5 per 100 EY). The risk for malignancies was not significantly increased for ETA and ADA compared with MTX (0.09, 0.27 and 0.07/100 person-years). Patients under ETA monotherapy developed more frequently incident inflammatory bowel disease (IBD) and incident uveitis (0.5 and 0.8/100 EY) than patients treated by ETA in combination with MTX (0.1 and 0.2/100 EY) or MTX alone (0.03 and 0.1/100 EY).<br />Conclusions and Relevance: Our data confirm the acceptable long-term tolerability of ETA and ADA in pJIA. However, whether the onset of IBD and uveitis during ETA monotherapy is a paradoxical effect or an inadequate response to therapy remains unclear and requires further investigation in this growing cohort.<br /> (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
- Subjects :
- Adalimumab therapeutic use
Adolescent
Antirheumatic Agents therapeutic use
Arthritis, Juvenile epidemiology
Autoimmune Diseases chemically induced
Biological Products adverse effects
Biological Products therapeutic use
Child
Etanercept therapeutic use
Female
Germany epidemiology
Humans
Inflammatory Bowel Diseases chemically induced
Inflammatory Bowel Diseases epidemiology
Male
Methotrexate adverse effects
Neoplasms chemically induced
Neoplasms epidemiology
Opportunistic Infections chemically induced
Opportunistic Infections epidemiology
Prospective Studies
Registries
Tumor Necrosis Factor-alpha antagonists & inhibitors
Uveitis chemically induced
Uveitis epidemiology
Adalimumab adverse effects
Antirheumatic Agents adverse effects
Arthritis, Juvenile drug therapy
Etanercept adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1468-2060
- Volume :
- 75
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Annals of the rheumatic diseases
- Publication Type :
- Academic Journal
- Accession number :
- 25926155
- Full Text :
- https://doi.org/10.1136/annrheumdis-annrheumdis-2014-206747