December 02, 2013
Treating juvenile arthritis early and aggressively with a combination drug regimen increases the likelihood of clinical inactive disease within a year for many patients, said Dr. Carol Wallace, professor of pediatrics and director of the division of rheumatology at the University of Washington and Seattle Children's Hospital.
Dr. Wallace focused her research on polyarticular juvenile idiopathic arthritis (poly-JIA), which she said affects approximately 30% of childhood arthritis sufferers and causes joint dysfunction, fevers, rash, or eye inflammation. She set out to achieve clinical inactive disease — defined as no joints with arthritis, no symptoms of arthritis, no eye involvement, a normal sedimentation rate, and a physician global assessment of no active arthritis — in patients after 6 months of aggressive drug therapy.
Her double-blind study involved 85 pediatric patients from 15 sites across the United States. The children were randomized into 2 treatment groups. Forty-two patients received the more aggressive combination therapy of methotrexate 0.5mg/kg per week by injection, etanercept 0.8mg/kg per week, and prednisolone 0.5mg/kg/d tapered to zero by 17 weeks. A second group of 43 patients received the less aggressive regimen of methotrexate 0.5mg/kg per week by injection and placebo etanercept and prednisolone.
According to Dr. Wallace, who presented her findings this past month at the annual meeting of the American College of Rheumatology in San Diego, 30 patients in the more aggressive therapy group achieved clinical inactive disease at least once, compared to 28 patients in the less aggressive therapy group. Patients in the aggressive therapy group spent a median of 139.5 days with clinical inactive disease, compared to a median of 79 days for children in the less aggressive therapy group.
“Childhood arthritis is one of the most common chronic diseases in children and the most common cause of acquired disability in children,” Dr. Wallace said, when asked to comment on her research. “Sufferers spend long periods of time, if not their entire childhood, with active disease.”
She noted that her clinical trial is the first to use inactive disease and remission of disease as key outcomes. Her findings show that a robust response at 4 months following initiation of aggressive treatment is predictive of clinical inactive disease by 6 months, and reinforces the importance of treating poly-JIA early and aggressively.
“A combination of an anti-TNF [tumor necrosis factor] agent,” Dr. Wallace said, “plus methotrexate and prednisolone results in earlier and longer periods of clinical inactive disease than subcutaneous high-dose methotrexate monotherapy.”
Giannini EH, Spalding SJ, Hashkes PJ, et al. Predictors and sustainability of clinical inactive disease in polyarticular juvenile idiopathic arthritis given aggressive therapy very early in the disease course. Abstract presented at the American College of Rheumatology annual conference. Oct. 27, 2013.