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Biologic therapies in polyarticular juvenile idiopathic arthritis. Comparison of long‐term safety data from the German biker registry

  • Objective: Biologics have an important role in the treatment of juvenile idiopathic arthritis (JIA). Long‐term safety data are limited. Direct comparison of different agents regarding occurrence of adverse events (AEs), especially of rare events, requires large quantities of patient years. In this analysis, long‐term safety with regard to AE of special interest (AESI) was compared between different biologics. Methods: Patients with nonsystemic JIA were selected from the German BIKER registry. Safety assessments were based on AE reports. Number of AEs, serious AEs, and 25 predefined AESIs, including medically important infection, uveitis, inflammatory bowel disease, cytopenia, hepatic events, anaphylaxis, depression, pregnancy, malignancy, and death, were analyzed. Event rates and relative risks were calculated using AEs reported after first dose through 70 days after last dose. Results: A total of 3873 patients entered the analysis with 7467 years of exposure to biologics. The most common AESIs were uveitis (n = 231) and medically important infections (n = 101). Cytopenia and elevation of transaminases were more frequent with tocilizumab (risk ratio [RR] 8.0, 95% confidence interval [CI] 4.2‐15, and RR 4.7, 95% CI 1.8‐12.2, respectively). Anaphylactic events were associated with intravenous route of administration. In patients ever exposed to biologics, eight malignancies were reported. Six pregnancies have been documented in patients with tumor necrosis factor inhibitors. No death occurred in this patient cohort during observation. Conclusion: Surveillance of pharmacotherapy as provided by the BIKER registry is an import approach, especially for long‐term treatment of children. Overall, tolerance was acceptable. Differences between biologics were noted and should be considered in daily patient care.
Metadaten
Author:Ariane Klein, Ingrid Becker, Kirsten Minden, Anton Hospach, Tobias Schwarz, Ivan FoeldvariORCiD, Boris Hügle, Michael Borte, Frank Weller-Heinemann, Frank Dressler, Jasmin Kümmerle-Deschner, Prasad Thomas Oommen, Dirk Föll, Ralf Trauzeddel, Christoph Rietschel, Gerd Horneff
URN:urn:nbn:de:hebis:30:3-529925
DOI:https://doi.org/10.1002/acr2.11091
ISSN:2578-5745
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/31943968
Parent Title (English):ACR open rheumatology
Publisher:Wiley
Place of publication:Medford, MA
Document Type:Article
Language:English
Year of Completion:2019
Date of first Publication:2019/11/24
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2020/03/04
Volume:2
Issue:1
Page Number:11
First Page:37
Last Page:47
Note:
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
HeBIS-PPN:46139538X
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0