PMID- 19483091
OWN - NLM
STAT- MEDLINE
DCOM- 20090910
LR  - 20151119
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 48
IP  - 8
DP  - 2009 Aug
TI  - Safety and efficacy of once weekly etanercept 0.8 mg/kg in a multicentre 12 week 
      trial in active polyarticular course juvenile idiopathic arthritis.
PG  - 916-9
LID - 10.1093/rheumatology/kep122 [doi]
AB  - OBJECTIVES: Etanercept, a recombinant TNF receptor fusion protein, has been 
      approved for the treatment of resistant polyarticular course juvenile idiopathic 
      arthritis at a dosage of 0.4 mg/kg twice weekly in children older than 4 years. 
      In adult patients, efficacy and safety of etanercept 25 mg twice weekly was 
      comparable with 50 mg once weekly. Therefore, safety and efficacy of etanercept 
      once weekly 0.8 mg/kg up to 50 mg s.c. was evaluated in a 3 month open label 
      trial. METHODS: Twenty patients 4 to 17 years old received 0.8 mg of etanercept 
      per kilogram of body weight subcutaneously once weekly for 3 months in an open 
      multicentre trial. Active polyarticular disease was defined by the presence of 
      five or more active joints with swelling, alternatively with pain or tenderness 
      combined with limitation of motion. Safety assessments were based on adverse 
      events (AEs) reports. Efficacy was assessed using the PedACR30/50/70 criteria. 
      RESULTS: At the start of treatment the patients showed high disease activity. A 
      rapid reduction of all disease activity parameters was observed. A PedACR30/50/70 
      response was reached by 75%/35%/10% of patients after 4 weeks, 90%/75%/35% after 
      8 weeks and 95%/75%/75% after 12 weeks of treatment. There were 37 AEs, none of 
      them serious, with injection site reactions and minor infections being the most 
      frequent. There was no drop out. Long-term follow-up of the patients will be 
      carried out in the German JIA Registry. CONCLUSION: Treatment with etanercept 
      once weekly using a double dosage leads to a significant improvement of disease 
      activity in patients with active polyarticular course juvenile idiopathic 
      arthritis and is well tolerated.
FAU - Horneff, Gerd
AU  - Horneff G
AD  - Department of Paediatrics, Asklepios Clinic Sankt Augustin, Sankt Augustin, 
      Germany. g.horneff@asklepios.com
FAU - Ebert, Annette
AU  - Ebert A
FAU - Fitter, Sigrid
AU  - Fitter S
FAU - Minden, Kirsten
AU  - Minden K
FAU - Foeldvari, Ivan
AU  - Foeldvari I
FAU - Kummerle-Deschner, Jasmin
AU  - Kummerle-Deschner J
FAU - Thon, Angelika
AU  - Thon A
FAU - Girschick, Herrmann J
AU  - Girschick HJ
FAU - Weller, Frank
AU  - Weller F
FAU - Huppertz, Hans I
AU  - Huppertz HI
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20090529
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adolescent
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Juvenile/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Drug Administration Schedule
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/*therapeutic use
MH  - Male
MH  - Receptors, Tumor Necrosis Factor/*therapeutic use
MH  - Treatment Outcome
EDAT- 2009/06/02 09:00
MHDA- 2009/09/11 06:00
CRDT- 2009/06/02 09:00
PHST- 2009/06/02 09:00 [entrez]
PHST- 2009/06/02 09:00 [pubmed]
PHST- 2009/09/11 06:00 [medline]
AID - kep122 [pii]
AID - 10.1093/rheumatology/kep122 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2009 Aug;48(8):916-9. doi: 10.1093/rheumatology/kep122. 
      Epub 2009 May 29.