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FDA Extends Juvenile Arthritis Indication for Adalimumab (Humira) to Include Patients 2 Years of Age and Older

Drug previously approved for patients aged 4 and older

The FDA has approved the extension of the indication for adalimumab (Humira, AbbVie) for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to include reducing signs and symptoms in patients 2 years of age and older. Adalimumab was approved in the U.S. in 2008 for polyarticular JIA in patients 4 years of age and older.

JIA is the most common form of childhood arthritis. Polyarticular JIA, which occurs in approximately 25% of all JIA patients, is one of seven types of JIA and involves five or more joints. Symptoms of the disease include painful, swollen, and tender joints; limping; morning stiffness; decreased activity; and the reluctance to use an arm or a leg. Early diagnosis and appropriate management of JIA are important in controlling this chronic disease.

Adalimumab is available in a 10- 20-, and 40-mg prefilled syringes and in a 40-mg auto-injector pen for use in patients 2 years of age and older with polyarticular JIAA. The appropriate dose is based on the patient’s weight.

In the U.S., adalimumab is used to reduce the signs and symptoms of moderate-to-severe rheumatoid arthritis in adults; moderate-to-severe polyarticular JIA in children 2 years of age and older; psoriatic arthritis in adults; ankylosing spondylitis in adults; and moderate-to-severe Crohn’s disease in adults and in children 6 years of age and older.

Adalimumab is also used to induce and sustain remission in adults with severe ulcerative colitis, and to treat moderate-to-severe chronic plaque psoriasis in adults who are ready for systemic therapy or phototherapy.

Adalimumab is a tumor necrosis factor (TNF) blocker that affects the immune system and can lower the patient's ability to fight infections. Serious and potentially fatal infections have occurred in patients treated with adalimumab. These infections have included tuberculosis and infections caused by viruses, fungi, or bacteria that have spread throughout the body.

Source: AbbVie; October 6, 2014.

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