Noted dermatologist Joshua Fox, MD, on what patients need to know about
topical immunomodulators
NY, NY October 2005 -
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.
Bio: Joshua L. Fox, M.D., F.A.A.D.
Joshua L. Fox, M.D. is a leading authority in the field of dermatology with an
expertise in skin cancer, cosmetic surgery, and laser procedures. As an official
spokesperson for the American Academy of Dermatology and the American Society of
Dermatologic Surgery, Dr. Fox has been an expert resource on dermatologic topics
for numerous television networks including ABC, CBS, CNN, NBC, Telemundo, talk
shows, radio stations, newspapers and magazines. Dr. Fox has served on the board
of the National Rosacea Foundation and has done clinical trials in both medical
and laser therapy in Rosacea.
He has received multiple research and clinical awards
including recognition from Top Doctors, Who's Who, Journal of Dermatologic Surgery
and Oncology, Community Service Award from the American Society of Dermatologic
Surgery, the prestigious Husic Award as well certificates of recognition for
service from multiple hospitals, civic, educational and community organizations.
Dr. Fox has authored and presented papers of his research on lasers, cosmetic procedures,
stretch marks, scars, skin cancer, bug bites, photosensitivity and various rashes.
As founder and director ofAdvanced Dermatology P.C. and The Center for Laser and
Cosmetic Surgery Dr. Fox and associates have expanded the practice to the one of
largest
in dermatology, laser & cosmetic surgery with more lasers than any hospital or
dermatology practice on the eastern coast. Dr. Fox is a graduate of the New York
University Medical Center of Skin and Cancer and has been on the advisory board
of the Psoriasis Foundation and National Rosacea Foundation among others. He has
also been a fellow of many societies including the International Academy of Cosmetic
Surgery, International Academy of Cosmetic Dermatology, and the Society for Investigative
Dermatology. Dr. Fox is the founder of the AAD Melanoma/Skin Cancer Prevention Program
in Queens, New York
since 1987. Dr. Fox has been Chief of Dermatology of several
major teaching hospitals including Mt. Sinai Hospital of Queens and Jamaica Medical
Center and is currently on the staff of ten NY area hospitals. Dr. Fox and Advanced
Dermatology the Center for Laser & Cosmetic Surgery have been used as a
resource center educating dermatologists, laser surgeons, & cosmetic surgeons and
others about lasers, cancer and cosmetic surgery. www.advancedd.com
|
Request an Appointment
