A powerful biologic offers hope—and some risks—to psoriasis patients

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, its especially promising for patients who havent responded, or have stopped responding, to other biologics.

“This is a drug where you give a shot and four weeks later the patients know theyre 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 its 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 Stelaras 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 didnt 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.”

[ pagebreak ]In some psoriasis patients, biologics gradually (and sometimes suddenly) stop working. Stelaras unique mechanism of action makes it a good alternative for these patients, as switching to another biologic is often successful in such cases.

“If a patient comes in and theyve never been on a biologic before, Im prescribing a TNF [inhibitor] for them,” says Craig Leonardi, MD, a clinical assistant professor of dermatology at St. Louis University and private practice dermatologist in St. Louis. ”But if theyve failed [on] Enbrel? Arent doing well on Humira? Thats a Stelara kind of patient, absolutely. Theyve done their hard time. Theres a reason to be using the drug.”

Another major difference between Stelara and older biologics is that the drug needs to be injected less frequently. Patients on Stelara receive a pair of initial shots four weeks apart, then an additional shot every 12 weeks. Other biologics are given as often as every other week, weekly, or twice a week.

Is Stelara safe?

Patients can achieve dramatic results with biologics, but the drugs have been hounded by safety concerns. Biologics work by suppressing the immune system, which can make patients more susceptible to infections, ranging from the flu to tuberculosis. As with other biologics, patients should undergo testing for tuberculosis before starting Stelara, and while taking the drug they should be tested for TB once a year.

Despite the potential for serious complications inherent to biologics, the side effects of Stelara generally include little more than upper respiratory tract infections (such as the common cold), fatigue, and minor body aches. “So far its been well tolerated,” says Dr. Leonardi.

The long-term safety of the drug remains unknown, however.

“Stelara is new, its high performance, it looks good, and it serves most well, but its not a first-line drug for me yet,” says Dr. Leonardi. “Whats missing right now is experience.” While TNF blockers have been used for more than a decade to treat arthritis (like psoriasis, an inflammatory condition), Stelara has been widely tested in clinical trials for just a few years, he says.

Biologics, moreover, have been linked to some scary side effects, even after FDA approval. In the spring of 2009, the maker of a biologic known as Raptiva voluntarily withdrew the drug from the market following reports of a rare but deadly brain infection. Then, in August, the FDA announced that it would require all TNF blockers to carry a so-called black-box warning stating that the drugs cause an increased risk of lymphoma and other cancers in children and adolescents.

Dr. Feldman tends to err on the side of safety. “If it were me, I would probably choose one of the drugs where we have a longer safety experience,” he says. But because “different people put their risks in different barrels,” he urges his patients to be involved in the decision-making process.

“Some people, you know, they smoke, they drive fast, and they want their psoriasis gone right away. They want the most powerful thing. Theyre not so worried about safety risk,” he says. “Other people are just the opposite. Theyre like, ‘I dont care how long it takes; I just want to be safe in how we treat this.”

Navani was aware of the potential cancer and immune system risks when she began taking Stelara, and although she says that “you never want to give up one problem for another,” she decided that alleviating the pain and embarrassment of her condition was worth the risk.

Will my insurance cover it?

Like many high-powered drugs, Stelara is expensive. The list price for one 45-milligram dose is $4,663, which has given some insurance companies pause.

A few dermatologists say insurers are requiring patients to try (and fail) an oral medication such as methotrexate and an older biologic before they will agree to cover a Stelara prescription. “Stelaras a little bit more expensive than the other biologics, and that may be the reason that theyre requiring that they fail one of the older ones,” says Dr. Lebwohl, who is also the chairman of the department of dermatology at the Mount Sinai School of Medicine, in New York City.

Brian Kenney, a spokesman for the drugs manufacturer, Centocor Ortho Biotech, says that few insurers have decided how to cover Stelara because its still so new. In the meantime, he says, the company is helping eligible patients who have commercial insurance with their out-of-pocket costs and will also provide referrals to those who may qualify for various patient-assistance programs.