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.
The approval is supported by findings from two pivotal Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled trials of Ustekinumab, a Fully Human anti–IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis (PSUMMIT I and PSUMMIT II), which evaluated the efficacy and safety of subcutaneously-administered STELARA 45 mg or 90 mg at weeks 0, 4 and then every 12 weeks. The trials included 927 patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dL in spite of previous treatment with conventional therapy. PSUMMIT II also included 180 patients with previous exposure to 1-5 tumor necrosis factor (TNF) inhibitors. Results from PSUMMIT 1 showed that at week 24, 42 percent and 50 percent of patients receiving STELARA 45 mg and 90 mg, respectively, achieved at least 20 percent improvement in signs and symptoms according to the American College of Rheumatology criteria (ACR 20), the primary endpoint for both studies. In PSUMMIT II, 44 percent of patients receiving STELARA 45 mg and 44 percent of patients receiving STELARA 90 mg achieved ACR 20 at week 24. Additionally, STELARA improved soft tissue components of the disease, including dactylitis (inflammation of the finger or toe), enthesitis (inflammation of the entheses, the sites where tendons or ligaments attach to bone) and skin component as measured by Psoriasis Area and Severity Index score (PASI) 75.
Data from the PSUMMIT I study was recently published in the June 13 edition of The Lancet.
"The Phase 3 PSUMMIT studies demonstrated the efficacy and safety of STELARA in one of the largest clinical development programs ever conducted for the treatment of active psoriatic arthritis," said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. "Today's approval of STELARA is significant for patients and physicians as it marks the first treatment approved for this devastating and complex disease since the introduction of anti-TNF biologic medicines more than a decade ago."
"We're proud to expand our portfolio of biologic treatment options for patients living with psoriatic arthritis to include an anti-IL-12/23 therapy such as STELARA," said Cindy Guzzo, M.D., Vice President, Medical Affairs, Janssen Biotech, Inc. "The efficacy and safety profile of STELARA, coupled with a dosing regimen of every 12 weeks after two starter doses, makes this a meaningful new option for patients battling this chronic condition."