More than 70% of children with juvenile arthritis may achieve complete drug-free inactive disease (DFID) following a tightly controlled treatment-to-target strategy, a study finds.
The study, “Treat to target (drug-free) inactive disease in DMARD-naive juvenile idiopathic arthritis: 24-month clinical outcomes of a three-armed randomised trial,” was published in the Annals of Rheumatic Diseases.
Juvenile idiopathic arthritis (JIA) is the most common autoimmune disease in children and is characterized by joint swelling, stiffness, and pain. Over the past years, treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs) significantly improved clinical outcomes for children with JIA.
However, stopping disease activity early on is the best possible scenario, because “once inactive disease is achieved, discontinuation of treatment might be possible,” according to the researchers of this study.
“If the initial treatment is not effective, subsequent treatment adjustments should still aim at achieving the treatment target [treatment-to-target strategy],” they said. However, these particular treatment strategies have never been explored in a study.
The randomized, single-blinded, multicenter BeSt for Kids trial (registration number 1574), conducted in the Netherlands, was designed to determine which of three different treatment-to-target strategies was the most effective and safe in children with early-onset JIA over the course of two years.
Primary outcomes included time to inactive disease and time to flare after DMARD discontinuation. Secondary outcomes included disease activity, as measured by ACRPedi30/50/70/90 scores, functional ability, and adverse events.
The trial enrolled a total of 94 children between the ages of 4 and 13, who were randomly divided into three treatment groups: 32 receiving sequential DMARD-monotherapy with Azulfidine (sulfasalazine) or methotrexate (group 1); 32 receiving a combination therapy of MTX and six weeks of prednisolone (group 2); and 30 receiving a combination therapy of methotrexate and Enbrel (etanercept) (group 3).
The treatment-to-target strategy consisted of adjusting DMARDs every three months while JIA remained active, with gradual drug discontinuation once the disease became inactive.
After 24 months, 71% of children in group 1, 70% in group 2, and 72% in group 3 reached a state of inactive disease. Moreover, 45% in group 1, 31% in group 2, and 41% in group 3 were able to discontinue medication altogether.
On average, the time to inactive disease was nine months in all three groups. Time to flare after DMARD discontinuation was also identical in all treatment groups, between three and 6.8 months. Disease activity scores and adverse events, which were considered mild in most cases, were also similar in children from all groups.
“Based on the results from our study, we conclude that DFID is a feasible goal in treatment of children with JIA, … resulting in [more than] 70% achieving inactive disease and 39% stopping all DMARDs after 24 months. In addition, we showed that tapering and discontinuation of treatment is a realistic goal,” the researchers wrote.
“Long-term follow-up of the BeSt for Kids cohort, including radiology results, is initiated to investigate possible lasting positive results of treatment-to-target in JIA,” they added.