Open AccessTrial of early aggressive therapy in polyarticular juvenile idiopathic arthritis
Author(s) -
Wallace Carol A.,
Giannini Edward H.,
Spalding Steven J.,
Hashkes Philip J.,
O'Neil Kathleen M.,
Zeft Andrew S.,
Szer Ilona S.,
Ringold Sarah,
Brunner Hermine I.,
Schanberg Laura E.,
Sundel Robert P.,
Milojevic Diana,
Punaro Marilynn G.,
Chira Peter,
Gottlieb Beth S.,
Higgins Gloria C.,
Ilowite Norman T.,
Kimura Yukiko,
Hamilton Stephanie,
Johnson Anne,
Huang Bin,
Lovell Daniel J.
Publication year - 2012
Publication title -
arthritis & rheumatism
Language(s) - English
Resource type - Journals
eISSN - 1529-0131
pISSN - 0004-3591
DOI - 10.1002/art.34343
Subject(s) - medicine , etanercept , placebo , prednisolone , clinical endpoint , juvenile rheumatoid arthritis , methotrexate , arthritis , adverse effect , clinical trial , surgery , rheumatoid arthritis , gastroenterology , alternative medicine , pathology
Abstract 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.