Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis. It is estimated that more than two million people in the U.S. are living with psoriatic arthritis, a chronic autoimmune disease characterized by both joint inflammation and psoriasis skin lesions.
"It is critical for dermatologists and rheumatologists to be able to offer new and novel treatment options to our adult patients living with psoriatic arthritis, a disease where additional biologic options are very much needed," said investigator and Steering Committee member Alice B. Gottlieb, triple board certified in dermatology, rheumatology and internal medicine, M.D., Ph.D, Chief and Dermatologist-in-Chief, Department of Dermatology, Tufts Medical Center. "Therapy that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), two naturally occurring proteins believed to play a role in the development of this debilitating immune-mediated inflammatory disease, could improve patient care."
For the treatment of psoriatic arthritis, STELARA is administered as a 45 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks, thereafter. For patients with co-existent moderate to severe plaque psoriasis weighing more than 220 lbs. (100 kg) the recommended dose is 90 mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks, thereafter.