According to a story from PR Newswire, the US Food and Drug Administration (FDA) has just approved a treatment for rare adult-onset Still’s disease for the first time ever. The drug that was approved is called canakinumab (marketed as Ilaris) and was cleared for all patients with active Still’s disease, including the rare adult-onset variant. This drug has previously been approved for patients aged two or older with systemic juvenile idiopathic arthritis.
About Adult-Onset Still’s Disease (AOSD)
Adult-onset Still’s disease is a rare form of Still’s disease, an autoinflammatory, systemic illness. It is characterized primarily by three symptoms: a distinctive, salmon-colored rash with bumps, pain in the joints, and fever. Still’s disease is effectively a form of juvenile arthritis with systemic impacts, and is more frequently found in children; though generally uncommon, the adult-onset form is even less frequently encountered. The cause of the illness is not well understood but appears to involve interleukin-1 (Il-1), as drugs that inhibit its activity can be effective. Aside from the previously mentioned rash, joint pain, and fever, patients may also experience severe fatigue, swelling of the lymph nodes, enlarged liver and spleen, increased white blood cell count, and fluid in the heart and lungs. Life-threatening and debilitating complications are possible. The disease is treated with a variety of anti-inflammatory drugs, such as steroids, anakinra, rituximab, and methotrexate. To learn more about adult-onset Still’s disease, click here.
For this approval, the effectiveness and safety of Ilaris was established using data from patients with systemic juvenile idiopathic arthritis, though safety was also evaluated in patients with adult-onset Still’s disease. The drug was approved for this disease under Priority Review, meaning that the FDA took action on the application in six months or less.
Treatment with Ilaris and similar anti-inflammatory, immune system suppressing treatments carries the risk of certain side effects, such as increased risk of infection, abdominal pain, reactions at the injection site, and macrophage activation syndrome, a potentially life threatening adverse reaction that should be treated promptly.
Patients with adult-onset Still’s disease should be excited about this news, which heralds the first ever approval specifically for this rare illness.
