Breaking News: FDA Approves Use of Benlysta for Children and Teens with Lupus

Children and teens living with lupus are now able to be treated with intravenous use of Benlysta (belimumab), the only biologic therapy developed and approved specially for lupus, now that the U.S. Food and Drug Administration has approved its use in children as young as five years of age.  Benlysta has been approved for treatment of lupus in adults since 2011.

This approval represents a major advancement for treating childhood lupus, which can be more aggressive and severe than it is in adults. The symptoms of childhood lupus are more intense, and the disease can have long-term effects on a child’s growth, quality of life, and even how long they live. It is estimated there are up to 10,000 children with lupus in the United States. 

Prior to this approval, children and teens only had access to older and less tolerable medications that were developed for other diseases and had never been tested in children for treating lupus. Therapies such as corticosteroids, antimalarials and immunosuppressant agents often have serious and debilitating health consequences from long-term use in children. 

Between 10 and 20 percent of all cases of lupus develop during childhood. People diagnosed in childhood are more likely to have higher rates of organ damage than people diagnosed as adults. The Lupus Foundation of America recognized these challenges and in 2006 established the first and only national childhood lupus research program, the Michael Jon Barlin Pediatric Lupus Research Program. This program supports discoveries in childhood lupus research and has funded important studies to develop better ways to treat and manage lupus in children and teens.

For example, Dr. Kathleen Sullivan, the Division Chief of Allergy and Immunology at the Children's Hospital of Philadelphia, has received Foundation funding for a five-year study to facilitate the development of non-invasive diagnostic tools for pediatric lupus nephritis. Sullivan is working to develop a simple test that can measure real-time evaluation of lupus disease activity in children.

In 2017, the Foundation started a partnership with the Childhood Arthritis and Rheumatology Research Alliance (CARRA) to bring together advocacy for and research on childhood lupus. Our goal is to identify the areas of greatest need in childhood lupus research and care and then work collaboratively to fill in the gaps.

Learn more about our childhood lupus research program.