SIMPONI ARIA is approved for the treatment of adults with moderately to severely active RA, adults with active ankylosing spondylitis (AS), patients 2 years of age and older with active PsA, and pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (pJIA). SIMPONI ARIA is currently approved in 24 countries, including the U.S. SIMPONI ARIA is a fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation. For adults with RA, PsA, and AS, the SIMPONI ARIA weight-based dosage regimen is 2 mg/kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. SIMPONI ARIA is given with methotrexate for the treatment of RA. For pediatric patients with pJIA and PsA, the SIMPONI ARIA BSA-based dosage regimen is 80 mg/m2 given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
In addition to its use in Crohn's disease, HUMIRA is also approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA is indicated as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA is also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-alpha), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases. To date, HUMIRA has been approved in 75 countries and more than 250,000 patients worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases.