Intermittent Tacrolimus Ointment Therapy Helps Prevent Relapse of Stabilized Atopic Dermatitis

kavin submitted, created time 4 months 2 weeks (www.medscape.com)

NEW YORK (Reuters Health) Jun 23 - In patients with stabilized atopic dermatitis, intermittent therapy with tacrolimus ointment was associated with significantly more flare-free days and longer time to first relapse compared with vehicle alone, according to a report in the June issue of the Journal of the American Academy of Dermatology.

Tacrolimus is a topical calcineurin inhibitor (TCI) and is manufactured in ointment form under the brand name Protopic by Astellas Pharma US Inc., which supported this multicenter study by U.S. researchers.

The study cohort, enrolled at 21 centers from November 2004 to July 2006, consisted of patients aged at least 2 years and diagnosed with atopic dermatitis that was rated at least moderate. The first (stabilization) phase consisted of an acute double-blind treatment period of 4 days, followed by an open-label tacrolimus ointment treatment period of up to 16 weeks. During double-blind treatment, patients were randomized 1:1 to receive either tacrolimus ointment or corticosteroid ointment.

The 197 patients whose atopic dermatitis symptoms were rated as clear or almost clear at the end of the first phase were eligible to continue into the second (maintenance) phase. They were re-randomized 2:1 to receive either blinded tacrolimus ointment (0.03% for children up through age 15 years, 0.1% for adults) or vehicle ointment. Each was applied once a day, 3 times a week to previously affected areas of atopic dermatitis for 40 weeks.

Patients treated with tacrolimus ointment had significantly more flare-free treatment days (mean: 177) than did those receiving vehicle (mean: 134) (p = .003). Similarly, median time to first relapse was significantly longer for patients treated with tacrolimus (169 days) compared with vehicle (43) (p = .037).

Rates of experiencing at least one relapse were similar. Following relapse treatment of up to 8 weeks of open-label tacrolimus ointment applied twice daily, the mean number of relapse days was significantly less with tacrolimus (46 days) than with vehicle (65 days) (p = .027).

The researchers, led by Dr. Debra Breneman of the University of Cincinnati College of Medicine, note that the applicability of the study's findings to a general group of patients with stabilized atopic dermatitis "may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial."

They also point out that prescribing guidelines issued in January 2006, while the study was underway, call for avoiding continuous long-term use of TCIs and limiting application to areas of involvement with atopic dermatitis.

Keywords: Tacrolimus Ointment Therapy patients dermatology Intermittent Tacrolimus Ointment Therapy atopic dermatitis