Barring cost issues, new systemic therapies could soon be on the forefront
St. Louis - In less than a year, three new biologic medications for psoriasis have been approved - alefacept (Amevive, Biogen), efalizumab (Raptiva, Genentech) and etanercept (Enbrel, Amgen Wyeth), and two more - infliximab (Remicade, Centocor) and adalimumab (Humira, Abbott Immunology) - are in phase 3 and 2 trials, respectively. While these systemic modalities have arrived within a relatively short time period, they are also running headlong into cost issues and insurance red tape.
"There's no question that if we could take cost off the table, these would be front-line therapies for everybody who needs a systemic treatment for their psoriasis," says Craig Leonardi, M.D., associate clinical professor of dermatology, St. Louis University, and a private practitioner with Central Dermatology in St. Louis. "In my practice, it's a very practical matter," he says. "If a patient has too much disease to put medication on twice a day, then they need a systemic treatment. Barring cost issues, we would all be migrating into biologics, because they appear to be far safer and perform better over the long run."
Time of the essence Dr. Leonardi believes that it's important to get these new treatments into the mainstream because many of the current systemic treatments for psoriasis that have been used for the last 20 to 30 years have failed patients.
"Some want to see more data in the psor-iasis population," says Dr. Leonardi. "Even though the safety profiles were very clean in the trials, some dermatologists want to wait a little while, so there's a little fence-sitting going on." But for these doctors, the excuses are running out, he adds, as more and more patients benefit from treatment with the new therapies.
"The ability (of biologics) to clear psoriasis exceeds many of the current systemic therapies. And where the new medications really shine is in the safety profiles," he says. "Some dermatologists find comfort in methotrexate because it has been used for more than 40 years. But in that time, methotrexate has accumulated 11 boxed warnings for a variety of serious issues including lymphoma, cirrhosis, pneumonitis and opportunistic infection. And few patients are able to take the drug for more than a decade."
As for cyclosporine, the U.S. Food and Drug Administration states that can be used for only one year due to nephrotoxicity concerns.
Still tricky With the newness of biologic agents, deciding on which treatment is best for each patient can be a bit tricky, according to Dr. Leonardi, who presented an overview of the new biologics at the Dermatology on the Beach conference in Sandestin, Fla. To help sort the pitfalls from the pluses, he constructed a consumer's guide for dermatologists which compares and contrasts the new biologic drugs and highlights the benefits and drawbacks of each. The table outlines how the drugs work, their features and side effects, as well as how fast they work.
Choosing the right biologic also depends on a patient's history. For example, if a patient has psoriatic arthritis, Enbrel might be a better choice than Raptiva or Amevive, because it's been proven to work in patients with that condition, he says. In some cases, a review of whether insurance companies are likely to approve or deny payment of the treatment plays a role, too.
The number of patients now using systemic therapies varies throughout the United States, according to Dr. Leonardi, and the treatment decision often hinges on the drugs' impressive price.
"Unfortunately, there are three of us in the exam room right now: the patient, the doctor and the insurance carrier," he says. "Most patients won't have access to these drugs without insurance stepping up to the plate."