my personal edition > dermatology other > news


  E-Mail this DGNews to a colleague

DGNews

Comparative Studies Show Tacrolimus is More Effective than Pimecrolimus For the Treatment of Eczema: Presented at AAD

Data Show Comparable Safety and Tolerability

WASHINGTON, DC -- February 6, 2004 -- Interim data from three studies presented today at the 62nd Annual Meeting of the American Academy of Dermatology demonstrate that tacrolimus ointment is more effective than pimecrolimus cream in the treatment of adult and pediatric patients with atopic dermatitis. These data also revealed that in the same patient populations, both treatments have similar safety profiles and no statistical difference with regard to burning and stinging. These findings support preliminary data from an earlier arm of these studies presented in January at the Skin Disease Education Foundation's 28th Hawaii Dermatology Seminar by Dr. Alan Fleischer, study investigator, professor, chair and director, General Dermatology Clinic, Wake Forest University Baptist Medical Center.

"These studies are the first true comparative trials to examine tacrolimus ointment and pimecrolimus cream in the same patient population, including age, disease severity, length of treatment, efficacy endpoints and adverse event coding scheme," said Dr. Fleischer. "When given a choice, our patients will typically opt for a more effective ointment rather than a less effective cream, so this is good news for dermatologists and patients."

The six-week, randomized, investigator-blinded studies evaluated 837 patients including children as young as two years of age with mild to severe AD. Treatment success was defined by the Investigator's Global Atopic Dermatitis Assessment as "clear" or "almost clear." The first arm of these studies examined adult patients with mild to very severe atopic dermatitis. At six weeks, 51% of patients treated with tacrolimus ointment 0.1% (n=177) were rated as clear or almost clear compared with 31% of those receiving pimecrolimus cream 1% (n=173), p=0.0002. The second arm evaluated pediatric patients (ages greater than or equal to 2 to <16) with moderate to very severe atopic dermatitis. Of those children treated with tacrolimus ointment 0.1% (n=96) 38% achieved treatment success compared with 20% treated with pimecrolimus cream 1% (n=102), p=0.006. The third arm evaluated pediatric patients (ages greater than or equal to 2 to <16) with mild atopic dermatitis. Fifty-four percent of patients treated with tacrolimus ointment 0.03% (n=142) achieved treatment success compared with 42% of those using pimecrolimus cream 1% (n=147), p=0.04.

"Patients treated with tacrolimus ointment 0.1% experienced a greater and more rapid reduction in itching symptoms," said John Y. Koo, M.D., professor and vice chairman, Department of Dermatology, University of California at San Francisco. "These studies revealed that tacrolimus and pimecrolimus patients had a comparable incidence of adverse events including burning and stinging. Previous studies indicated a higher rate of burning and stinging in tacrolimus patients due to the fact that patients treated with tacrolimus had significantly greater disease severity with symptoms typically decreasing as skin healed."

Efficacy of the two treatments was comprehensively measured at day one and weeks one, three and six, using the physician-rated Body Surface Area (BSA) assessment, and the six-point Investigator's Global Atopic Dermatitis Assessment (IGADA), which evaluated the major symptoms of AD. An EASI score also was calculated and a patient's evaluation of itch was recorded at each visit.

"In these studies, tacrolimus ointment 0.1% seems to work better for all severities of eczema than pimecrolimus," said Dr. Koo. "Cream formulations do have their place, such as for morning application due to its elegance, but these results show that patients in need of maximum therapeutic effect will benefit more from taking tacrolimus ointment twice a day."

Topical immunomodulators are the first new class of prescription drugs to be developed in more than 40 years for the treatment of eczema. The FDA approved tacrolimus ointment, the steroid-free alternative, in December 2000 for short-term and intermittent long-term therapy to treat the signs and symptoms of moderate to severe eczema in children and adults. Tacrolimus ointment, from Fujisawa Healthcare, Inc. (study funder), is available by prescription in two concentrations for adults, 0.03 percent and 0.1 percent. For children ages two to 15, only the 0.03 percent concentration is indicated. Pimecrolimus cream 1% was approved in December 2001 for short-term and intermittent long-term treatment of mild to moderate eczema in patients ages two and older.


SOURCE: Wake Forest University Baptist Medical Center

E-Mail this DGNews to a colleague

To print, use this version