PMID- 34449981
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240404
IS  - 2578-5745 (Electronic)
IS  - 2578-5745 (Linking)
VI  - 3
IP  - 11
DP  - 2021 Nov
TI  - Efficacy and Safety of Etanercept Biosimilars Compared With the Originator for 
      Treatment of Juvenile Arthritis: A Prospective Observational Study.
PG  - 779-787
LID - 10.1002/acr2.11325 [doi]
AB  - OBJECTIVE: Analysis of etanercept biosimilars in pediatric patients with juvenile 
      idiopathic arthritis (JIA) in comparison with the etanercept originator in terms 
      of efficacy and safety. METHODS: Patients diagnosed with JIA who started 
      treatment with either the etanercept originator or a biosimilar after January 1, 
      2017, were selected from the German BIKER registry (Biologics in Paediatric 
      Rheumatology Registry). Furthermore, patients who started therapy with the 
      originator and switched to a biosimilar during the course of therapy were 
      identified. For both patient groups, disease activity and safety were examined 
      and compared separately. RESULTS: After January 1, 2017, 348 patients started 
      treatment with the etanercept originator (n = 293) or a biosimilar (n = 55). 
      Another 57 patients switched to a biosimilar during the course of therapy. A 
      significant decrease or a stable remission of disease activity was observed in 
      both patient groups. The safety profiles were comparable, and frequencies and 
      types of adverse events (AEs) and serious AEs were similar in patients starting 
      therapy with the originator or a biosimilar. Only injection site reactions 
      occurred slightly more frequently under biosimilar therapy, without having an 
      impact on therapy adherence. In patients who switched therapy, the AE rate per 
      100 patient-years was comparable before (26.4) and after (32.1) the switch. 
      CONCLUSION: In patients with JIA who require treatment with etanercept, the 
      originator is still used much more frequently. However, our study highlights the 
      equivalence of etanercept biosimilars for therapy for JIA. Increased use of these 
      biosimilars in pediatric patients can therefore be recommended without 
      hesitation.
CI  - (c) 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on 
      behalf of American College of Rheumatology.
FAU - Thiele, Franz
AU  - Thiele F
AUID- ORCID: 0000-0001-6689-8827
AD  - Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany.
FAU - Klein, Ariane
AU  - Klein A
AUID- ORCID: 0000-0001-9771-8710
AD  - Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of 
      Cologne, Cologne, Germany.
FAU - Hospach, Anton
AU  - Hospach A
AUID- ORCID: 0000-0001-5656-9165
AD  - Klinikum Stuttgart, Olgahospital Stuttgart, Stuttgart, Germany.
FAU - Windschall, Daniel
AU  - Windschall D
AUID- ORCID: 0000-0003-3156-5103
AD  - Northwest German Rheumatology Center, St. Josef Stift, Sendenhorst, Germany.
FAU - Mrusek, Sonja
AU  - Mrusek S
AD  - Practice for Paediatric Rheumatology, Baden-Baden, Germany.
FAU - Ruehlmann, J Michael
AU  - Ruehlmann JM
AD  - Practice for Paediatric Rheumatology, Goettingen, Germany.
FAU - Horneff, Gerd
AU  - Horneff G
AUID- ORCID: 0000-0001-5491-7832
AD  - Asklepios Clinic Sankt Augustin, Sankt Augustin, Germany, and University of 
      Cologne, Cologne, Germany.
LA  - eng
GR  - Roche/
GR  - AbbVie Deutschland/
GR  - Pfizer/
GR  - Merck Sharp and Dohme/
PT  - Journal Article
DEP - 20210827
PL  - United States
TA  - ACR Open Rheumatol
JT  - ACR open rheumatology
JID - 101740025
PMC - PMC8593791
EDAT- 2021/08/28 06:00
MHDA- 2021/08/28 06:01
PMCR- 2021/08/27
CRDT- 2021/08/27 17:46
PHST- 2021/04/27 00:00 [received]
PHST- 2021/07/13 00:00 [accepted]
PHST- 2021/08/28 06:00 [pubmed]
PHST- 2021/08/28 06:01 [medline]
PHST- 2021/08/27 17:46 [entrez]
PHST- 2021/08/27 00:00 [pmc-release]
AID - ACR211325 [pii]
AID - 10.1002/acr2.11325 [doi]
PST - ppublish
SO  - ACR Open Rheumatol. 2021 Nov;3(11):779-787. doi: 10.1002/acr2.11325. Epub 2021 
      Aug 27.