PMID- 31943968
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2578-5745 (Electronic)
IS  - 2578-5745 (Linking)
VI  - 2
IP  - 1
DP  - 2020 Jan
TI  - Biologic Therapies in Polyarticular Juvenile Idiopathic Arthritis. Comparison of 
      Long-Term Safety Data from the German BIKER Registry.
PG  - 37-47
LID - 10.1002/acr2.11091 [doi]
AB  - 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.
CI  - (c) 2019, The Authors. ACR Open Rheumatology published by Wiley Periodicals, Inc. 
      on behalf of American College of Rheumatology.
FAU - Klein, Ariane
AU  - Klein A
AUID- ORCID: 0000-0001-9771-8710
AD  - Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany, and University of 
      Cologne, Cologne, Germany.
FAU - Becker, Ingrid
AU  - Becker I
AD  - University of Cologne, Cologne, Germany.
FAU - Minden, Kirsten
AU  - Minden K
AD  - German Rheumatism Research Centre Berlin, Berlin and Charite University Medicine, 
      Berlin, Germany.
FAU - Hospach, Anton
AU  - Hospach A
AD  - Olga Hospital, Stuttgart, Germany.
FAU - Schwarz, Tobias
AU  - Schwarz T
AD  - St. Josef-Stift Sendenhorst, Sendenhorst, Germany.
FAU - Foeldvari, Ivan
AU  - Foeldvari I
AD  - Hamburg Centre for Pediatric and Adolescent Rheumatology, Hamburg, Germany.
FAU - Huegle, Boris
AU  - Huegle B
AUID- ORCID: 0000-0003-1145-6719
AD  - German Centre for Pediatric and Adolescent Rheumatology, Garmisch-Partenkirchen, 
      Germany.
FAU - Borte, Michael
AU  - Borte M
AD  - Children's Hospital Sankt Georg, Leipzig, Germany.
FAU - Weller-Heinemann, Frank
AU  - Weller-Heinemann F
AD  - Prof. Hess Children's Hospital, Bremen, Germany.
FAU - Dressler, Frank
AU  - Dressler F
AD  - Hanover Medical School, Hanover, Germany.
FAU - Kuemmerle-Deschner, Jasmin
AU  - Kuemmerle-Deschner J
AD  - University Hospital Tuebingen, Tubingen, Germany.
FAU - Oommen, Prasad Thomas
AU  - Oommen PT
AD  - University Hospital Dusseldorf, Dusseldorf, Germany.
FAU - Foell, Dirk
AU  - Foell D
AUID- ORCID: 0000-0002-1946-3916
AD  - University Children's Hospital Munster, Munster, Germany.
FAU - Trauzeddel, Ralf
AU  - Trauzeddel R
AD  - Helios Klinik Berlin-Buch, Berlin, Germany.
FAU - Rietschel, Christoph
AU  - Rietschel C
AD  - Clementine Children's Hospital, Frankfurt, Germany.
FAU - Horneff, Gerd
AU  - Horneff G
AD  - Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany, and University of 
      Cologne, Cologne, Germany.
LA  - eng
PT  - Journal Article
DEP - 20191124
PL  - United States
TA  - ACR Open Rheumatol
JT  - ACR open rheumatology
JID - 101740025
PMC - PMC6957918
EDAT- 2020/01/17 06:00
MHDA- 2020/01/17 06:01
PMCR- 2019/11/24
CRDT- 2020/01/17 06:00
PHST- 2019/08/29 00:00 [received]
PHST- 2019/09/17 00:00 [accepted]
PHST- 2020/01/17 06:00 [entrez]
PHST- 2020/01/17 06:00 [pubmed]
PHST- 2020/01/17 06:01 [medline]
PHST- 2019/11/24 00:00 [pmc-release]
AID - ACR211091 [pii]
AID - 10.1002/acr2.11091 [doi]
PST - ppublish
SO  - ACR Open Rheumatol. 2020 Jan;2(1):37-47. doi: 10.1002/acr2.11091. Epub 2019 Nov 
      24.