Christopher Griffiths, M.D., a professor of dermatology at the University of Manchester, in the UK, says he prescribes Stelara to his patients who aren’t helped by TNF inhibitors, even if they have heart disease.
It’s important for doctors to closely monitor the heart health of patients taking Stelara or any biologic, says Dr. Griffiths, who has served as a consultant to Centocor and Abbott, among other companies.
But, he adds, this should be standard procedure in anyone with psoriasis, since previous studies have turned up an association between severe psoriasis and heart disease. Experts believe inflammation may contribute to both conditions.
“There is no doubt that there’s a link between having severe psoriasis, which makes you eligible for biological therapies, and increased risk of having cardiovascular disease, so that has to be factored in here,” Dr. Griffiths says.
Joel M. Gelfand, MD, an assistant professor of dermatology at the University of Pennsylvania’s Perelman School of Medicine, in Philadelphia, says the analysis underscores the “importance of doing large, long-term randomized studies of psoriasis therapies,” since psoriasis is a “lifetime disease.” Like Dr. Griffiths, Dr. Gelfand has had financial relationships with drug companies including Abbott and Centocor.
Dr. Gelfand says he doesn’t hesitate to prescribe Stelara to his patients with severe cases of psoriasis, but only after they first try TNF inhibitors or methotrexate, psoriasis drugs that have been used for a decade—or several decades, in the case of methotrexate—and have established safety profiles.
Ustekinumab appears to have a “very low risk” of serious side effects, Dr. Gelfand says, but it will require more study. “We still have to get more information to fully understand its safety profile,” he says.
The FDA, which has reviewed the clinical trials in Ryan’s analysis as part of the drug approval process, does not require Stelara or any other approved biologic to carry a warning about cardiovascular risk.
Psoriasis is thought to be a type of autoimmune disorder. Faulty immune cells cause skin cells to overproduce, which in turn causes the disorder’s characteristic lesions. Biologics, including Stelara and briakinumab, work by blocking the action of certain immune cells.
