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Randomized Controlled Trial
. 2017 Feb 6;15(1):11.
doi: 10.1186/s12969-017-0138-4.

A comparison of three treatment strategies in recent onset non-systemic Juvenile Idiopathic Arthritis: initial 3-months results of the BeSt for Kids-study

P C E Hissink Muller  1   2 , D M C Brinkman  3   4 , D Schonenberg  5 , Y Koopman-Keemink  6 , I C J Brederije  3 , W P Bekkering  3 , T W Kuijpers  5 , M A J van Rossum  7 , L W A van Suijlekom-Smit  8 , J M van den Berg  5 , C F Allaart  9 , R Ten Cate  3
Affiliations
Randomized Controlled Trial

A comparison of three treatment strategies in recent onset non-systemic Juvenile Idiopathic Arthritis: initial 3-months results of the BeSt for Kids-study

P C E Hissink Muller et al. Pediatr Rheumatol Online J. .

Abstract

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.

Conclusion: 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.

Trial registration: NTR1574 . Registered 3 December 2008.

Keywords: Biologicals; Inactive disease; Juvenile idiopathic arthritis; Treat to target; Treatment strategy study; Window of opportunity.

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Figures

Fig. 1
Fig. 1
Study profile of the BeSt for Kids study
See this image and copyright information in PMC

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