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Topical immunomodulators (TIMs), the first new class of drugs in over 40 years to treat eczema, were hailed as revolutionary treatments when they were first marketed a few years ago, offering new hope to the 15 million Americans suffering from this chronic, unsightly skin condition. Today, however, these miracle prescription creams are under assault because of data suggesting they may increase the risk of cancer.
“TIMs are the first drugs that effectively target the diseased skin and not just the symptoms of eczema,” says Joshua Fox, MD, a leading dermatologist and founder of Advanced Dermatology . “They also don’t contain corticosteroids, which are the standard treatment for eczema but can suppress the immune system and have other side effects like thinning or lightening of the skin.”
Two TIMs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of eczema: Protopic (tacrolimus) ointment and Elidel (pimecrolimus) cream. The drugs, which were available orally before they were developed as topical treatments, interfere with the immune reaction that leads to eczema.
In large clinical trials conducted all over the world, the drugs have been found to significantly relieve eczema symptoms and improve the appearance of the skin, with fewer side effects than corticosteroid creams. “We were excited about these new therapies until the FDA issued an advisory in March of 2005 warning that animal tests have shown an increase in cancer with use of TIMs,” says Dr. Fox. The doses used in those studies were 30 times higher than those typically given to humans, but a small number of skin cancers and lymphomas have also been found in children and adults who used TIMs, but it does not seem to be more than would be statistically expected.
So what’s a patient to do? This situation might be similar to that faced by arthritis patients using the COX-2 pain relievers Vioxx, Bextra and Celebrex. “These were the only drugs out there that worked for many people, yet they were shown to increase the risk of cardiovascular disease. Although Vioxx and Bextra have been taken off the market, some people are choosing to continue taking Celebrex despite the risks. Each person and his or her doctor have to assess the benefits and risks of a certain drug for that individual. Unlike the above situation TIMs have not been proven to have increased risk-only a suggestion of possible increased risk, ” Fox adds.
Until more is known about any real link to cancer—and researchers are actively studying the potential link, although it may take a decade before they know definitively—Dr. Fox advises patients to follow the recommendations of the FDA:
Reserve Elidel and Protopic as last-resort treatments.
If other drugs fail to control your symptoms or you can’t tolerate them, talk to your dermatologist about using Elidel and Protopic for a short period of time and/or intermittently. “We don’t advise that you use the drugs continuously or for extended periods of time until we know more about their long-term safety,” says Dr. Fox.
Use the lowest doses needed to control your symptoms.
Don’t use TIMs if you have a weakened or compromised immune system or have a history of lymphomia or leukemia. Also, the drugs shouldn’t be used by children younger than two years of age because the data aren’t clear regarding the effects of TIMs on the developing immune system (almost 500,000 of the nearly 2 million perscriptions for these topical medications between June ‘03 and May ‘04 were for children under 2 years of age).
What is eczema?
Eczema is a chronic skin condition that inflames the skin, causing pain, itching, dryness, swelling, cracking, weeping and scaling. Skin infections can occur if bacteria invade the skin lesions. Eczema can affect any part of the body, but typically occurs on the face and neck, and the insides of the elbows, knees and ankles in children and adults. The unsightly appearance of eczema scales can lead to depression and a loss of self-esteem.
According to the American Academy of Dermatology, about 15 million Americans suffer from eczema. It affects about one-fifth of school-age children, 60% of whom continue to wrestle with the disease in adulthood.