FDA approves new psoriasis drug Stelara

Stelara offers patients a new treatment option

September 25, 2009

Stelara, a new drug for treating moderate to severe psoriasis in adults, was approved today by the U.S. Food and Drug Administration. Known by the generic name ustekinumab, the drug is injected in the skin, and works by blocking part of the body's immune system.

Stelara is a "very significant medication," said Dr. Craig Leonardi, a dermatologist in St. Louis, Mo. who served as a lead investigator in clinical trials for the drug. Leonardi believes Stelara is particularly effective for patients who've seen little or no response to treatments with other medications.

"Another unique feature of this drug," Leonardi added, "was when patients were doing well, they were treated to a 'drug holiday' to see how fast it came back." When Stelara was withdrawn, psoriasis symptoms were slow to return.

"It's not a cure," Leonardi said, "but psoriasis did not come back with a vengeance."

The drug blocks two proteins—interleukin 12 and interleukin 23—produced by the immune system, according to Bruce Bebo, Jr., director of research and medical programs for the National Psoriasis Foundation. The proteins are believed to play an important role in the development of psoriasis and other inflammatory diseases.

In psoriasis and psoriatic arthritis, the body's immune system behaves as though it is under attack, overproducing parts of the body's chemical arsenal.

In June 2008, Dan Farrington, now chair-elect of the National Psoriasis Foundation Board of Trustees, and Foundation volunteer Ellen Clements testified on behalf of the drug. Both shared their experiences living with psoriasis and emphasized that a "one-size-fits-all" treatment approach does not work. At the hearing's close, the committee voted unanimously to recommend that the FDA approve Stelara to treat moderate to severe psoriasis.

Stelara "adds a lot to our arsenal," said Bebo. "We're always happy when there is a new tool for treating psoriasis. It's a pretty big new step."

A study in the British medical journal The Lancet earlier this year noted that as many as 42 percent of patients treated in a clinical trial with Stelara saw the severity of their psoriasis reduced by 90 percent. "Side effects in the clinical trial were generally mild," Bebo noted.

Stelara was approved in Canada last December for treating moderate to severe psoriasis in adults, following clinical trials that involved more than 3,000 patients. It has also been approved for use in Europe.