Universität zu Köln

Klein, Ariane, Klotsche, Jens, Huegle, Boris, Minden, Kirsten, Hospach, Anton, Weller-Heinemann, Frank, Schwarz, Tobias, Dressler, Frank, Trauzeddel, Ralf, Hufnagel, Markus, Foeldvari, Ivan, Borte, Michael, Kuemmerle-Deschner, Jasmin, Brunner, Juergen, Oommen, Prasad Thomas, Foell, Dirk, Tenbrock, Klaus, Urban, Andreas and Horneff, Gerd (2020). Long-term surveillance of biologic therapies in systemic-onset juvenile idiopathic arthritis: data from the German BIKER registry. RHEUMATOLOGY, 59 (9). S. 2287 - 2299. OXFORD: OXFORD UNIV PRESS. ISSN 1462-0332

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Klein, Ariane UNSPECIFIED UNSPECIFIED UNSPECIFIED Klotsche, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Huegle, Boris UNSPECIFIED UNSPECIFIED UNSPECIFIED Minden, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Hospach, Anton UNSPECIFIED UNSPECIFIED UNSPECIFIED Weller-Heinemann, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Schwarz, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Dressler, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Trauzeddel, Ralf UNSPECIFIED UNSPECIFIED UNSPECIFIED Hufnagel, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Foeldvari, Ivan UNSPECIFIED UNSPECIFIED UNSPECIFIED Borte, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmerle-Deschner, Jasmin UNSPECIFIED UNSPECIFIED UNSPECIFIED Brunner, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Oommen, Prasad Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Foell, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Tenbrock, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Urban, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-320846
DOI:	10.1093/rheumatology/kez577
Journal or Publication Title:	RHEUMATOLOGY
Volume:	59
Number:	9
Page Range:	S. 2287 - 2299
Date:	2020
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1462-0332
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MACROPHAGE ACTIVATION SYNDROME; INTERLEUKIN-1 RECEPTOR ANTAGONIST; CHILDHOOD ARTHRITIS; DOUBLE-BLIND; ETANERCEPT; SAFETY; CHILDREN; EFFICACY; MALIGNANCIES; TOCILIZUMAB Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/32084