Stelara: A New Drug for Psoriasis

In some psoriasis patients, biologics gradually (and sometimes suddenly) stop working. Stelara’s 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 they’ve never been on a biologic before, I’m 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 they’ve failed [on] Enbrel? Aren’t doing well on Humira? That’s a Stelara kind of patient, absolutely. They’ve done their hard time. There’s 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 it’s been well tolerated,” says Dr. Leonardi.

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

“Stelara is new, it’s high performance, it looks good, and it serves most well, but it’s not a first-line drug for me yet,” says Dr. Leonardi. “What’s 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. They’re not so worried about safety risk,” he says. “Other people are just the opposite. They’re like, ‘I don’t 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. “Stelara’s a little bit more expensive than the other biologics, and that may be the reason that they’re 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 drug’s manufacturer, Centocor Ortho Biotech, says that few insurers have decided how to cover Stelara because it’s 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.

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