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Stelara: A New Drug for Psoriasis

. Thursday, August 11, 2011
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stelara After she was diagnosed with psoriasis in 1992, at the age of 17, Sherrina Navani tried just about “everything and anything”—natural remedies, topical treatments, prescription drugs such as methotrexate—to heal the cracking, bleeding plaques that covered 90% of her body. Nothing worked.

Then, in 2006, the 32-year-old from Jersey City enrolled in a clinical trial for ustekinumab, a then-experimental biologic medication for psoriasis that has since been approved by the U.S. Food and Drug Administration (FDA) under the name Stelara. Her skin cleared within a month, but after two-and-a-half years on the injectable drug, she learned that she was pregnant with her second daughter and had to quit the study. (Like most biologics used for psoriasis, Stelara has not been tested in pregnant women and therefore the risks to the fetus are unknown.) Her psoriasis returned “full blown,” she says.

In September 2009, two months after her baby was born, Stelara was approved by the FDA, and in November Navani began using it again.

“I took my first shot and I started feeling relief in a week,” says Navani, the founder of NewYorkMother.com. Her skin is now 95% clear.

Stelara, the newest biologic for psoriasis, is a powerful drug that is approved only for moderate to severe cases of plaque psoriasis, an immune system disorder that causes red, inflamed skin lesions, often covered with silvery scales.

Stelara gives hope to hard-to-treat patients like Navani, and because it has a different mechanism of action, it’s especially promising for patients who haven’t responded, or have stopped responding, to other biologics.

“This is a drug where you give a shot and four weeks later the patients know they’re getting better, almost to a person,” says the chairman of the medical board of the National Psoriasis Foundation, Mark G. Lebwohl, MD, who helped recruit patients for many of the clinical trials of Stelara. “It is so uniformly effective and so dramatically effective that the results are quite spectacular.”

Despite the positive early reviews, experts caution that Stelara, like all biologics, has the potential to bring harm as well as relief. The drug carries a small risk of serious side effects, and, because it’s new, its safety in the long term is still unclear.

A new weapon to fight psoriasis
Biologics are the newest generation of psoriasis medications. Unlike older prescription drugs for psoriasis, which are made from synthetic chemicals and are taken orally, biologics are made from bioengineered human or animal proteins and are delivered via injection or IV. They work by blocking the action of certain immune cells or chemical messengers that play a role in psoriasis.

Before Stelara, there were two classes of biologics. The first class, known as TNF blockers (or inhibitors), targets proteins in the immune system and includes drugs such as Enbrel (etanercept) and Humira (adalimumab). The second contains just one drug, Amevive (alefacept), which works by blocking the white blood cells known as T cells.

One of Stelara’s main selling points is that it has a different mechanism of action than the other biologics on the market. “The TNF inhibitors were a huge step forward but yet there were even some people who didn’t get better with those drugs,” says Steven R. Feldman, MD, PhD, a professor of dermatology at Wake Forest University Health Sciences, in Winston-Salem, N.C. “[With Stelara] we have yet one more tool.”


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