Universität zu Köln

Becker, Ingrid ORCID: 0000-0001-5829-3553 and Horneff, Gerd (2017). Risk of Serious Infection in Juvenile Idiopathic Arthritis Patients Associated With Tumor Necrosis Factor Inhibitors and Disease Activity in the German Biologics in Pediatric Rheumatology Registry. Arthritis Care Res., 69 (4). S. 552 - 561. HOBOKEN: WILEY. ISSN 2151-4658

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Abstract

Objective. To examine the effects of tumor necrosis factor inhibitors on the risk for serious infections and other influencing factors in a registry. Methods. Patients exposed for the first time to etanercept, adalimumab, or methotrexate and serious infections were identified in theGerman BiologicRegistry for Pediatric Rheumatology (BIKER) registry. Serious infection rates per 1,000 observation-years and relative riskswere calculated. Cox regressionidentifiedrisk factorsandprovidedhazard ratios (HRs) for occurrence of infections. Results. A total of 3,350 patients with 5,919 observation-years fulfilled the inclusion criteria for the study. The first biologic agents were etanercept (1,720 cases) and adalimumab (177 cases). A total of 1,453 patients were treated with methotrexate and no biologic agent. In total, 28 serious infections were reported in 26 patients (4.7 per 1,000 patient-years), 5 with methotrexate (1.6 per 1,000 patient-years), 21 with etanercept (8.1 per 1,000 patient-years), and 2 with adalimumab (9.7 per 1,000 patientyears). Significant univariate risk factors for infection were therapy with biologic agents, disease duration before therapy start, corticosteroid medication, nonbiologic premedications, higher clinical Juvenile Arthritis Disease Activity Score including maximal 10 joints (cJADAS10) at therapy start, and highermean cJADAS10 during therapy. In multivariate Cox regression, only biologic therapy and cJADAS10 at therapy start remained significant. Risk for infection was increased by etanercept (univariate HR 6.0 [95% confidence interval (95% CI) 2.0-17.5]) or adalimumab (HR 7.3 [95% CI 1.3-40.0]) compared to methotrexate as well as by an elevated cJADAS10 at therapy start (HR 1.1 [95% CI 1.0-1.2] per unit increase). Conclusion. The total rate of serious infections reported in the BIKER registry seems low. Treatment with etanercept or adalimumab increases the risk for serious infection slightly, compared to methotrexate. Disease activity expressed by cJADAS10 appears to be an independent risk factor.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Becker, Ingrid UNSPECIFIED orcid.org/0000-0001-5829-3553 UNSPECIFIED Horneff, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-235472
DOI:	10.1002/acr.22961
Journal or Publication Title:	Arthritis Care Res.
Volume:	69
Number:	4
Page Range:	S. 552 - 561
Date:	2017
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	2151-4658
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LONG-TERM SAFETY; HERPES-ZOSTER; BRITISH-SOCIETY; JIA REGISTRY; ETANERCEPT; CHILDREN; EFFICACY; METHOTREXATE; RATES; THERAPY Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23547