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Rheumatology (Oxford). 2019 Dec 17. pii: kez577. doi: 10.1093/rheumatology/kez577. [Epub ahead of print]

Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry.

Author information

1
Centre for Paediatric Rheumatology, Department of Paediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
2
Department of Pediatrics, Medical Faculty, University of Cologne, Cologne, Germany.
3
German Rheumatism Research Centre Berlin, and Charité, University Medicine, Berlin, Germany.
4
German Centre Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, Germany.
5
Pediatric Rheumatology, Olga Hospital, Stuttgart, Germany.
6
Department of Pediatrics, Prof. Hess Children's Hospital, Bremen, Germany.
7
Department of Pediatric Rheumatology, St Josef Hospital, Sendenhorst, Germany.
8
Pediatric Pneumology, Allergology, Neonatology, Immunology, Medizinische Hochschule Hannover, Hannover, Germany.
9
Department of Pediatrics, Helios Klinik, Berlin-Buch, Germany.
10
Department of Pediatrics and Adolescent Medicine, University Medical Center, Freiburg, Germany.
11
Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.
12
Pediatric Immunology, Children's Hospital Sankt Georg, Leipzig, Germany.
13
Pediatric Rheumatology, University Childreńs Hospital, Tuebingen, Germany.
14
Department of Pediatrics I, Medical University, Innsbruck, Austria.
15
Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, University Children's Hospital, Heinrich-Heine-University, Düsseldorf, Germany.
16
Department of Pediatrics, Rheumatology and Immunology, University Hospital, Münster, Germany.
17
Department of Pediatric and Adolescent Medicine, RWTH Aachen University, Aachen, Germany.
18
Klinikum St Marien Klinik für Kinder und Jugendliche - Rheumatology/Pneumology, Amberg, Germany.

Abstract

OBJECTIVE:

Using data from the German Biologics JIA Registry (BIKER), long-term safety of biologics for systemic-onset JIA with regard to adverse events of special interest was assessed.

METHODS:

Safety assessments were based on adverse event reports after first dose through 90 days after last dose. Rates of adverse event, serious adverse event and 25 predefined adverse events of special interest were analysed. Incidence rates were compared for each biologic against all other biologics combined applying a mixed-effect Poisson model.

RESULTS:

Of 260 systemic-onset JIA patients in this analysis, 151 patients received etanercept, 109 tocilizumab, 71 anakinra and 51 canakinumab. Patients with etanercept had higher clinical Juvenile Arthritis Disease Activity Score 10 scores, active joint counts and steroid use at therapy start. Serious adverse events were reported with higher frequency in patients receiving canakinumab [20/100 patient years (PY)] and tocilizumab (21/100 PY). Cytopenia and hepatic events occurred with a higher frequency with tocilizumab and canakinumab. Medically important infections were seen more often in patients with IL-6 or IL-1 inhibition. Macrophage activation syndrome occurred in all cohorts with a higher frequency in patients with canakinumab (3.2/100 PY) and tocilizumab (2.5/100 PY) vs anakinra (0.83/100 PY) and etanercept (0.5/100 PY). After adjustment only an elevated risk for infections in anakinra-treated patients remained significant. Three definite malignancies were reported in patients ever exposed to biologics. Two deaths occurred in patients treated with etanercept.

CONCLUSION:

Surveillance of pharmacotherapy as provided by BIKER is an import approach especially for patients on long-term treatment. Overall, tolerance was acceptable. Differences between several biologics were noted and should be considered in daily patient care.

KEYWORDS:

Still’s disease; adverse event; anakinra; biologics; canakinumab; etanercept; juvenile idiopathic arthritis; safety; systemic-onset; tocilizumab; treatment

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