NEW YORK, N.Y. – Data presented here today at the Academy 2004 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 (AD).
Overall results also revealed that in the same patient populations, both treatments have similar safety profiles including no statistical difference with regard to burning and stinging. These findings were presented by Alan Fleischer, M.D., study investigator, professor, chair and director of the General Dermatology Clinic, Wake Forest University Baptist Medical Center. They support preliminary data presented by Fleischer in February at the academy’s annual meeting.
“This study is the first, large, well-designed comparative trial to examine tacrolimus ointment and pimecrolimus cream in the same patient populations, including age, disease severity, length of treatment, efficacy endpoints and adverse events,” said Fleischer. “In this study, tacrolimus ointment seemed to work better for all severities of atopic dermatitis than pimecrolimus, including mild sufferers and particularly in severe patients.”
The six-week, randomized, investigator-blinded study evaluated 1,056 patients, including children as young as 2, with mild to severe AD. Treatment success was defined by the Investigator’s Global Atopic Dermatitis Assessment (IGADA) as “clear” or “almost clear.”
The first arm evaluated adult patients with mild to very severe AD. At six weeks, 46 percent of 210 patients treated with tacrolimus ointment 0.1 percent were rated as “clear” or “almost clear” compared with 27 percent of 203 patients receiving pimecrolimus cream 1 percent. The second arm evaluated tacrolimus ointment 0.1 percent or pimecrolimus cream 1 percent in pediatric patients ages 2 to 15 with moderate to very severe AD. Of 112 children treated with tacrolimus ointment, 32 percent achieved treatment success compared with 18 percent of children treated with pimecrolimus cream. The third arm evaluated tacrolimus ointment 0.03 percent or pimecrolimus cream 1 percent in pediatric patients with mild AD. Forty-seven percent of 208 children treated with tacrolimus ointment achieved treatment success compared with 41 percent of 217 patients using pimecrolimus cream.
“This study revealed that tacrolimus and pimecrolimus patients had a comparable tolerability including burning and stinging,” said Fleischer. “Patients treated with tacrolimus ointment for all severities of atopic dermatitis experienced a greater and more rapid reduction in itching symptoms, which is key to improving the quality of life for these patients.”
Efficacy of the two treatments was comprehensively measured at day 1 and weeks 1, 3 and 6, using the physician-rated Body Surface Area (BSA) assessment, and the six-point IGADA, which evaluated the major symptoms of AD. An Eczema Area and Severity Index score also was calculated and a patient’s evaluation of itch was recorded at each visit.
“This study supports existing data that show that tacrolimus and pimecrolimus have the same safety profile and comparable tolerability,” said Fleischer. “Tacrolimus works more rapidly at the skin’s surface than pimecrolimus, yet existing data indicate that neither medication showed a trend toward higher blood accumulation over time deeming them equally safe.”
The study was funded by Fujisawa Healthcare Inc., which makes tacrolimus ointment. It is available by prescription in two concentrations for adults, 0.03 percent and 0.1 percent. For children ages 2 to 15, the 0.03 percent concentration is indicated.
Topical immunomodulators, a nonsteroidal class of topical agents that are safer than corticosteroids, are the first new class of prescription drugs to be developed in more than 40 years for the treatment of AD. 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 AD in children and adults. Pimecrolimus cream 1 percent was approved in December 2001 for short-term and intermittent long-term treatment of mild to moderate AD in patients ages 2 and older.
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About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. It is licensed to operate 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.