FDA approves Stelara for psoriatic arthritis

The Food and Drug Administration has approved Stelara (ustekinumab, Janssen Biotech) alone or in combination with methotrexate for the treatment of psoriatic arthritis in patients ages 18 and older.

Ustekinumab is administered with 45 mg subcutaneous injections at weeks zero and four, and then every 12 weeks thereafter, according to a news release. Patients who weigh more than 220 lbs. who have coexistent moderate-to-severe plaque psoriasis should receive a dose of 90 mg.

Approval by the FDA came after the conclusion of two phase 3, multicenter, randomized, double-blind, placebo-controlled trials of ustekinumab. The trials enrolled 927 patients who were diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein levels of at least 0.3 mg/dL despite treatment with conventional therapies.

In one trial, 42 percent and 50 percent of patients receiving ustekinumab 45 mg and 90 mg, respectively, achieved at least 20 percent improvement in signs and symptoms of their condition at 24 weeks. Results of the study were published in The Lancet.

“Therapy that targets the cytokines interleukin-12 and interleukin-23, two naturally occurring proteins believed to play a role in the development of this debilitating immune-mediated inflammatory disease, could improve patient care,” Alice B. Gottlieb, M.D., Ph.D., chief, department of dermatology, Tufts Medical Center, Boston, and study investigator, said in the news release.

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