SAN DIEGO, CA—Early aggressive therapy in a group of patients with polyarticular juvenile idiopathic arthritis (JIA), with high initial disease activity and proportion with RF positivity, was associated with prolonged periods of clinical inactive disease (CID), according to results of a 24-month extension study of TREAT-JIA, presented at the 2013 ACR/ARHP Annual Meeting.
TREAT-JIA (Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis) was a double-blind, randomized, placebo-controlled trial (n=85) in patients with onset of polyarticular JIA <12 months to determine if CID could be achieved by 6 months. The aggressive treatment arms were either methotrexate 0.5mg/kg/wk SQ or etanercept 0.8mg/kg/wk + prednisolone 0.5mg/kg/day (tapered to 0 by Week 17) + methotrexate 0.5mg/kg/wk.
Carol A. Wallace, MD, from Seattle Children’s Hospital and Research Institute, Seattle, WA, and colleagues performed a 24-month extension study to follow these children and understand long-term outcomes. Patients who completed >6 months in the TREAT-JIA study were eligible to enroll in this extension study, regardless of response during the original trial and whether or not they continued to receive the same medications. Twelve of the 15 original study sites participated and enrolled 52 of 77 (67.5%) eligible patients, 48 of whom returned for follow-up visits.
At enrollment into the extension study, 21 (44%) were receiving etanercept and methotrexate, 13 (27%) were receiving methotrexate alone, 6 (12%) were receiving etanercept alone, 7 (15%) were receiving no medications or NSAIDs alone, and 1 patient each were receiving prednisone, adalimumab, and abatacept. Twenty-five (52%) entered the extension study in CID, while 23 (48%) had active disease.
Patients were followed for a mean of 21.4 months (range 9–24 months); (56%) spent >50% of their follow-up time in CID. Those RF(-) tended to spend more study time in CID than RF(+) patients (52% vs. 43%), as did those who were ANA(-) 58% vs. 47% ANA(+).
Patients who achieved CID at 6 months in the TREAT study tended to spend more time in CID (58% vs. 45%) than did those who ended the TREAT study in active disease (55% vs. 43%; P=0.0420). “Patients with active disease had low levels of disease activity,” Dr. Wallace noted.
No serious adverse events or adverse events grade 3 or higher were reported. Four patients had six infections that required systemic antibiotics: two episodes of sinusitis and one episode each of pharyngitis, pharyngitis with ear infection, ear infection, and skin rash.