Universität zu Köln

Atemnkeng Ntam, V., Klein, A. and Horneff, G. . Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis-data from the German BIKER registry. Expert Opin. Drug Saf.. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1744-764X

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Abstract

Background: The IL-1 receptor-antagonist anakinra is recommended for the treatment of systemic juvenile idiopathic arthritis (sJIA) and was recently approved for first-line treatment. Long-term data from clinical practise are scarce. Methods: SJIA patients from the German biologics in pediatric rheumatology (BIKER) registry starting anakinra were grouped into two cohorts: Patients in the first-line cohort received no prior sJIA treatment except NSAID and a maximum of 3 days of steroids. Second-line cohort patients were pre-treated with steroids; DMARDs or biologics. Patient characteristics, disease-activity parameters, efficacy, and safety-parameters were compared. Results: Until December 2018, 51 anakinra patients were documented, representing 117.96 patient-years. Mean disease duration was 3.5 (+/- 3.8) years. At baseline, all anakinra first-line users had active systemic disease compared to 82% in the second-line users. Significant JADAS-10 improvement at last follow-up was observed in both cohorts (p = 0.02, p = 0.0014). Substantial numbers of patients in both groups reached JADAS-MDA/JADAS-remission/inactive disease (66.7%50%50% in first-liners and 60%45%70% in second-liners). Rates of serious adverse events were comparable and consistent with the overall AE profile of anakinra in patients. Conclusion: This analysis adds to the established safety profile of anakinra and demonstrates that anakinra is effective as first-line or second-line treatment.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Atemnkeng Ntam, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Klein, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Horneff, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-311143
DOI:	10.1080/14740338.2021.1843631
Journal or Publication Title:	Expert Opin. Drug Saf.
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1744-764X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language INTERLEUKIN-1 RECEPTOR ANTAGONIST; MACROPHAGE ACTIVATION SYNDROME; RHEUMATOID-ARTHRITIS; DISEASE; ETANERCEPT; CHILDREN; CANAKINUMAB; ANTIBODY; CRITERIA; TRIAL Multiple languages Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/31114