NEW YORK — Tacrolimus proved to be more efficacious and no more irritating than pimecrolimus in the first large head-to-head comparison of the two topical immunomodulators in patients with atopic dermatitis, Dr. Alan B. Fleischer Jr. said at the American Academy of Dermatology's Academy 2004 meeting.
Previous studies had suggested “that tacrolimus ointment was much more effective than pimecrolimus cream, but the issue of tolerability—burning, stinging, redness—was quite unclear,” said Dr. Fleischer, professor and chair of dermatology at Wake Forest University, Winston-Salem, N.C.
As the result of these studies, he added, tacrolimus can be said to be not only more effective, but also equally well tolerated.
Dr. Fleischer directed the 6-week, randomized, investigator-blinded study of 1,056 patients with mild to severe atopic dermatitis (AD). Overall, 43% of patients who received tacrolimus were judged by the Investigator's Global Atopic Dermatitis Assessment to be “clear or almost clear,” compared with 31% of patients who received pimecrolimus, for a P value of less than .0001.
Only in children aged 2-15 years who had mild AD and were treated with 0.03% tacrolimus did the drug fail to show a statistically significant effect on this outcome variable. (See chart.)
On another measure—the 0- to 72-point Eczema Area and Severity Index (EASI)—the mean score of patients taking tacrolimus declined by 53 points, compared with a mean decline of 39 points for pimecrolimus patients, for a P value of less than .0001.
Itch scores showed a particularly profound decline among pediatric and adult patients with moderate to severe AD. Among such children, for example, the difference in itch scores reached a P value of .006 by the first week. Children with mild AD who were treated with the less potent concentration of tacrolimus also itched less than those treated with pimecrolimus, but the difference was not dramatic until day 43, when the P value reached .008.
Tolerability scores, which were first collected at the end of week 1 of therapy, never demonstrated a statistical difference between the two agents.
The study was sponsored by Fujisawa Healthcare Inc., which makes tacrolimus ointment.
Dr. Fleischer said a presumed tolerability advantage for pimecrolimus emerged from preapproval studies that did not involve patient groups with equally severe AD and used different criteria to judge side effects.
Some patients will still prefer a cream formulation to the ointment vehicle used for tacrolimus, and Dr. Fleischer said he personally believes there is a role for both medications.
“They're both safer than topical steroids used over the long term,” he said. “A young woman may not want to put an ointment on her face in the morning, but now we can give patients a choice.