Children with juvenile arthritis now have two more FDA-approved options when it comes to exploring treatment choices. The biologic medications adalimumab (Humira) and abatacept (Orencia) were approved by the FDA back to back in February and April of 2008, respectively.

Adalimumab, an anti-TNF agent, was approved for use as a treatment to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) inpatients 4 years of age and older. Abatacept was approved for use to reduce signs and symptoms in children and adolescents 6 years of age and older with moderate to severe polyarticular juvenile idiopathic arthritis (JIA).

“To have two medications approved weeks apart for JRA is blockbuster,” says Dan Lovell, MD, MPH, Associate Director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center. “In the history of drug development for juvenile arthritis we’ve only come up with one [other biologic FDA approved for children] so for these to be approved is great.”

More choice

FDA approval means wider availability of these medications, presenting new choices for kids who haven’t been able to tolerate or haven’t had success with other treatments. “There is no one biologic that works for every patient so it’s important to have options,” says Dr. Lovell.

In general, biologic therapies work at the cellular level of the immune system, changing the way inflammation in your body works. Because of these effects on the immune system, all biologic medications pose an increased risk of infection and related side effects. Different biologics work to stop inflammation through different ways, or mechanisms. Adalimumab blocks a protein involved in inflammation called TNF and abatacept adjusts the way certain T cells work.

With these approvals, Dr. Lovell says, adalimumab may become a biologic option prescribed to children before trying other biologics, or it may be a choice for children who have failed another anti-TNF medication. As Dr. Lovell explains, you can fail one anti-TNF and have success with another. In clinical trials, Dr. Lovell says, abatacept worked for a number of patients who had failed anti-TNF therapy and it seemed to be well tolerated.

Drug differences


This medication is given through injections. Its approval was based on data from a study of 171 children age 4 to 17 that had active moderate to severe disease despite previous treatment with multiple medications. In the 48-week study, fewer children treated with adalimumab experienced disease flare compared to placebo.