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Ann Rheum Dis. 2016 May;75(5):855-61. doi: 10.1136/annrheumdis-annrheumdis-2014-206747. Epub 2015 Apr 29.

Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA).

Author information

1
German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany Charité Universitätsmedizin Berlin, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.
2
German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany.
3
German Center for Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, Germany.
4
Professor Hess Children's Hospital, Bremen, Germany.
5
German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany Charité Universitätsmedizin Berlin, Department of Rheumatology and Clinical Immunology, Berlin, Germany.
6
Asklepios Kinderklinik Sankt Augustin GmbH, Sankt Augustin, Germany.
7
German Rheumatism Research Centre Berlin, a Leibniz Institute, Berlin, Germany Charité Universitätsmedizin Berlin, Children's university hospital, Berlin, Germany.

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.

OBJECTIVES:

To investigate the rates of serious adverse events (SAE) and of events of special interest (ESI) under ETA and ADA treatment.

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.

MAIN OUTCOMES AND MEASURES:

We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate (MTX).

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).

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.

KEYWORDS:

Autoimmune Diseases; DMARDs (biologic); Infections; Juvenile Idiopathic Arthritis; Methotrexate

[Indexed for MEDLINE]

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