Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis.
Author(s): Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, Szer IS,
Ringold S, Brunner HI, Schanberg LE, Sundel RP, Milojevic D, Punaro MG, Chira P,
Gottlieb BS, Higgins GC, Ilowite NT, Kimura Y, Hamilton S, Johnson A, Huang B,
Lovell DJ; Childhood Arthritis and Rheumatology Research Alliance.
Affiliation(s): Seattle Children's Hospital, Seattle, WA, USA. cwallace@u.washington.edu
Publication date & source: 2012, Arthritis Rheum. , 64(6):2012-21
OBJECTIVE: To determine whether aggressive treatment initiated early in the
course of rheumatoid factor (RF)-positive or RF-negative polyarticular juvenile
idiopathic arthritis (JIA) can induce clinical inactive disease within 6 months.
METHODS: Between May 2007 and October 2010, a multicenter, prospective,
randomized, double-blind, placebo-controlled trial of 2 aggressive treatments was
conducted in 85 children ages 2-16 years with polyarticular JIA of <12 months'
duration. Patients received either methotrexate (MTX) 0.5 mg/kg/week (maximum 40
mg) subcutaneously, etanercept 0.8 mg/kg/week (maximum 50 mg), and prednisolone
0.5 mg/kg/day (maximum 60 mg) tapered to 0 by 17 weeks (arm 1), or MTX (same
dosage as arm 1), etanercept placebo, and prednisolone placebo (arm 2). The
primary outcome measure was clinical inactive disease at 6 months. An exploratory
phase determined the rate of clinical remission on medication (6 months of
continuous clinical inactive disease) at 12 months.
RESULTS: By 6 months, clinical inactive disease had been achieved in 17 (40%) of
42 patients in arm 1 and 10 (23%) of 43 patients in arm 2 (χ(2) = 2.91, P =
0.088). After 12 months, clinical remission on medication was achieved in 9
patients in arm 1 and 3 patients in arm 2 (P = 0.053). There were no significant
interarm differences in adverse events.
CONCLUSION: Although this study did not meet its primary end point, early
aggressive therapy in this cohort of children with recent-onset polyarticular JIA
resulted in clinical inactive disease by 6 months and clinical remission on
medication within 12 months of treatment in substantial proportions of patients
in both arms.
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