Stelara Receives FDA Approval To Treat Active Psoriatic Arthritis

The FDA recently approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis.

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, according to Janssen Biotech.

The approval is supported by findings from two pivotal Phase III multicenter, randomized, 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 45mg or 90mg 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, according to Janssen Biotech.

Data from the PSUMMIT I study was recently published in the June 13 edition of The Lancet.

The safety results of Stelara observed in the PSUMMIT studies were consistent with the known safety profile of Stelara in the labeled moderate to severe plaque psoriasis indication, which has five years of safety experience in clinical trials.