Progress continues in treating pediatric skin ailments

Over the past five to six years, the availability of the topical calcineurin inhibitors Protopic (tacrolimus, Astellas) and Elidel (pimecrolimus, Novartis) has "changed dramatically how we manage our patients with AD," says Amy S. Paller, M.D., professor and chair of dermatology and professor of pediatrics at Northwestern University's Feinberg School of Medicine.

However, The Food and Drug Administration (FDA)'s decision to add black box warnings to these drugs' labels has exerted a profound effect on patients and prescribers.

The decision rests on "the theoretical plausibility of an increased risk of cancer without any real evidence of it at this time," Dr. Paller says.

Nevertheless, the recently released warnings already have made it impossible for many patients to get these medications because the drugs have been removed from government and insurance formularies, she says. At the same time, Dr. Paller says the warnings have "caused primary care doctors to proactively take patients off these treatments, once again compromising patient care."

On a positive note, prescribers are "pleased to finally have specific wording to deal with," says Lawrence F. Eichenfield, M.D., professor of pediatrics and dermatology and chief, pediatric and adolescent dermatology at the University of California, San Diego, School of Medicine and Children's Hospital, San Diego.

During the year that dermatologists awaited the warning's wording, he says, "There was both much opinion and an increasing database that made us less concerned about the attributability (to the drugs) of malignancy or lymphomas."

Nevertheless, Dr. Eichenfield says the waiting period created a twofold burden: Families fretted about potential health risks from having used the products, while physicians worked to dispel these worries. These concerns, moreover, reduced use of the products, he adds.

But now, Dr. Eichenfield says, "It's my sense that physicians are more comfortable with the data, and with using the drugs responsibly and appropriately. Most experts in AD believe that they're incredibly important for management of many patients with eczema."

Treatment a family affair

There is also a growing support for recognizing AD's impact on quality of life, not just on patients, but also on their families, he says (Chamlin SL et al. J Invest Dermatol. 2005 Dec;125(6):1106-1111. Arch Pediatr Adolesc Med. 2005 Aug;159(8):745-50. Pediatrics. 2004 Sep;114(3):607-611).

"As physicians, we can probably improve our care of patients with AD and their families by acknowledging the disease's impact on the life of the family, and doing a better job in follow-up visits of assessing disease severity - not just how the skin looks on that day, but also trying to get a sense of what the course of the skin has been," along with the consequences of that course, Dr. Eichenfield says.

"The other thing we need to recognize is that when we say a disease is moderate or severe, it's not just the extent of skin surface that's involved. It's also the persistence of the disease or frequency of recurrences and flares" that should guide treatment, he elaborates.