Xeljanz (tofacitinib) Approved for Juvenile Idiopathic Arthritis

The U.S. Food and Drug Administration (FDA) has approved the medicine Xeljanz® (tofacitinib) to treat active polyarticular course juvenile idiopathic arthritis (JIA). This approval is for children and adolescents 2 years and older. Xeljanz tablet and oral solution are approved for this use.1

Xeljanz is a drug known as a Janus kinase (JAK) inhibitor. It is the only JAK inhibitor approved in the United States to treat active polyarticular course JIA (pcJIA).1

What is juvenile idiopathic arthritis?

Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease. The cause of JIA is not known. JIA is arthritis that begins before age 16 and lasts for at least 6 weeks. About 300,000 children in the United States have a form of JIA.1

Polyarticular JIA

There are 6 categories of JIA. One type is polyarticular JIA. People with polyarticular JIA have:1

  • Arthritis in 5 or more joints
  • Arthritis that affects small (hands and feet) and large (knees, hips, and ankles) joints

Xeljanz for polyarticular course JIA

Xeljanz was approved for pcJIA based on a phase 3 clinical trial. The study involved 2 phases held over 44 weeks. In total 398 people participated in the study.1 This study looked at the safety and efficacy of Xeljanz. The drug was taken as a tablet or solution based on body weight and personal preference.

The trial showed that people with pcJIA had significantly fewer disease flares than in the placebo group. People who took XELJANZ had a 31 percent occurrence of disease flare compared to 55 percent of people who took the placebo.1

XELJANZ is already approved for:1

  • Adults with moderate to severe rheumatoid arthritis after methotrexate failure
  • Adults with psoriatic arthritis after DMARD (disease-modifying antirheumatic drug) failure
  • Adults with moderate to severe ulcerative colitis after TNF (tumor necrosis factor) blocker failure.

This new approval allows the prescribing of Xeljanz for a new, fourth indication: the treatment of pcJIA in children and adolescents 2 years and older.1

Why is this approval for JIA important?

Children with pcJIA are more challenging to treat because of the involvement of many joints. Children with pcJIA do not always respond to treatment and therefore are at increased risk for joint damage.

This results in worse outcomes and decreased quality of life. Although more treatments are becoming available, there is still a lot that is unknown about pcJIA.2

Things to think about

Xeljanz can increase the risk of serious infections. These infections can lead to hospitalization or death. Infections can include tuberculosis, and other bacterial, viral, or fungal infections.1

Xeljanz should not be used in combination with biologic DMARDs or potent immunosuppressants. Xeljanz can increase the chance of malignancies, such as lymphoma.1

There are other serious risks associated with Xeljanz treatment. Xeljanz is not right for everyone. Talk to your doctor about the risks and benefits of Xeljanz and whether it is right for you.

Before taking Xeljanz, tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Xeljanz.

By providing your email address, you are agreeing to our privacy policy.

Join the conversation

or create an account to comment.

Community Poll

How does your pet support your RA journey?