The study was made of up two parts. In the first, it tested adalimumab in two groups of children, those who were taking methotrexate and those who were not. In the first part of the study both the methotrexate and nonmethotrexate groups were given adalimumab for 16 weeks. Children who improved then were put in the second part of the trial. Those children were randomly divided into two groups and either continued on adalimumab or given a placebo (a shot containing no medicine) for 32 weeks or until disease flare.

Patient responses were measured using the American College of Rheumatology Pediatric(ACR Pedi) 30 score, which represents a 30percent or greater improvement in JIA signs and symptoms, such as the number of swollen joints with loss of motion, assessment of pain and level of disability. A flare was defined as a worsening of 30 percent or more in at least three of the six ACR Pedi response variables, a minimum of two active joints, and no more than one indicator improving by 30 percent.

In the second part of the study, significantly fewer children receiving adalimumab flared, whether they were on methotrexate or not. Forty three percent of children given the drug flared compared to 71 percent of those on placebo. And, 37 percent of those on both methotrexate and adalimumab flared compared to 65 percent of children receiving methotrexate and placebo.

Efficacy and safety were assessed throughout the study. Injection site pain and injection site reaction were the most common adverse reactions. This happened in under 20 percent of children. Overall, improvements were maintained for up to two years in patients who received adalimumab throughout the study.


This medication is given through infusions. Like adalimumab, it may be used alone or in combination with methotrexate. It should not be used along with TNF blockers or other biologics. Its FDA approval was based on the AWAKEN trial in which the medication was studied for efficacy and safety in children age 6 to 17 with moderately to severely active JIA who had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate or anti-TNF biologic.

The three-part study lasted one year. It began with 190 children who had had arthritis for approximately four years and a majority of whom had not used a biologic before. The trial was made up of children with oligoarticular, polyarticular and systemic types of JIA. About 30 percent had previously had an inadequate response to a TNF blocker or anakinra.

In the first part of the study, which lasted four months, all of the children received abatacept. Improvement and flare was based on the ACR Pedi 30. In the second part of the trial, those children who had success on abatacept either continued on abatacept or started the placebo for six months. This part of the study ended when flare occurred. In the third part, children were allowed to get back on abatacept if they were given the placebo or continue treatment if they were on abatacept all along.