A comparison of three treatment strategies in recent onset non-systemic Juvenile Idiopathic Arthritis: initial 3-months results of the BeSt for Kids-study.
BACKGROUND
Combination therapy with prednisone or etanercept may induce earlier and/or more improvement in disease activity in Disease Modifying Anti Rheumatic Drug (DMARD) naïve non-systemic Juvenile Idiopathic Arthritis (JIA) patients. Here we present three months clinical outcome of initial treatments of the BeSt-for-Kids study.


METHODS
Included patients were randomized to either: 1. initial DMARD-monotherapy (sulfasalazine (SSZ) or methotrexate (MTX)), 2. Initial MTX / prednisolone-bridging, 3. Initial combination MTX/etanercept. Percentage inactive disease, adjusted (a) ACR Pedi30, 50 and 70 and JADAS after 6 and 12 weeks of treatment (intention to treat analysis) and side effects are reported.


RESULTS
94 patients (67% girls, 32 (arm 1), 32 (arm 2) and 30 (arm 3) with median (InterQuartileRange) age of 9.1 (4.7-12.9) years were included. 38% were ANA positive, 10 had oligo-articular disease, 68 polyarticular JIA and 16 psoriatic arthritis. Baseline median (IQR) ACRpedi-scores: VAS physician 49 (40-58) mm, VAS patient 54 (37-70) mm, ESR 6.5 (2-14.8)mm/hr, active joint count 8 (5-12), limited joint count 3 (1-5), CHAQ score 0.88 (0.63-1.5). In arm 1, 17 started with MTX, 15 with SSZ. After 3 months, aACR Pedi 50 was reached by 10/32 (31%), 12/32(38%) and 16/30 (53%) (p = 0.19) and aACR Pedi 70 was reached by 8/32 (25%), 6/32(19%) and 14/30(47%) in arms 1-3 (p = 0.04). Toxicity was similar. Few serious adverse events were reported.


CONCLUSIONS
After 3 months of treatment in a randomized trial, patients with recent-onset JIA achieved significantly more clinical improvement (aACRPedi70) on initial combination therapy with MTX / etanercept than on initial MTX or SSZ monotherapy.


BACKGROUND
NTR1574 . Registered 3 December 2008.
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. p.hissinkmuller@lumc.nl.|Department of Pediatrics/Pediatric Rheumatology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands. p.hissinkmuller@lumc.nl.
P C E
PC
Hissink Muller
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.|Department of Pediatrics, Alrijne Hospital Leiderdorp, Leiderdorp, The Netherlands.
D M C
DM
Brinkman
Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital AMC, University of Amsterdam, Amsterdam, The Netherlands.
D
D
Schonenberg
Department of Pediatrics, Hagaziekenhuis Juliana Children's Hospital, The Hague, The Netherlands.
Y
Y
Koopman-Keemink
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
I C J
IC
Brederije
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
W P
WP
Bekkering
Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital AMC, University of Amsterdam, Amsterdam, The Netherlands.
T W
TW
Kuijpers
Department of Pediatric Rheumatology, Amsterdam Rheumatology and Immunology Center location Reade Amsterdam, Amsterdam, The Netherlands.
M A J
MA
van Rossum
Department of Pediatrics/Pediatric Rheumatology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
L W A
LW
van Suijlekom-Smit
Department of Pediatric Hematology, Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital AMC, University of Amsterdam, Amsterdam, The Netherlands.
J M
JM
van den Berg
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
C F
CF
Allaart
Department of Pediatrics/Pediatric Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.
R
R
Ten Cate
D000284:Administration, Oral; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D012460:Sulfasalazine / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D012460:Sulfasalazine; D000068800:Etanercept; D008727:Methotrexate
Biologicals; Inactive disease; Juvenile idiopathic arthritis; Treat to target; Treatment strategy study; Window of opportunity