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Tacrolimus Cream Appears Effective for Mild to Moderate Psoriasis With Few Adverse Effects: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 6, 2007 -- Twice daily applications of tacrolimus cream 0.1% and 0.5% are safe and effective for the treatment of mild to moderate plaque psoriasis in adults, researchers reported here at the 65^th annual meeting of the American Academy of Dermatology (AAD).

The research was highlighted by the AAD in a special session of distinguished research poster presentations on February 5^th.

"This study indicates that this treatment works and is safe for mild to moderate psoriasis," said lead investigator and presenter J. Michael Maloney, MD, practicing dermatologist and clinical researcher, Cherry Creek Research, Denver, Colorado.

"Insurers won't pay for biologics to treat mild to moderate psoriasis. This could become a good alternative," Dr. Maloney added.

In the randomized, double-blind, vehicle-controlled study, investigators evaluated the efficacy and safety of tacrolimus cream 0.1% and 0.5% in a cohort of adults with mild to moderate plaque psoriasis.

The study randomized 76 men and 52 women with a median age of 46 years in a 1:1:1 design to twice daily application of tacrolimus cream 0.1%, 0.5% or placebo/vehicle cream for 8 weeks, followed by 2 weeks of observation.

The majority of patients (62%) had a baseline Physician's Static Global Assessment (PSGA) score of 3 on a 6-point scale denoting "clear" to "very severe" symptoms.

Mean baseline Psoriasis Area and Severity Index (PASI) score was 7.9, and mean percent body surface area (BSA) affected was 8.2%.

Primary efficacy endpoint of treatment success was clear (0) or almost clear (1) scores based on the PSGA score at the end of treatment. They evaluated for safety by comparing rates of adverse events.

Efficacy rates on the PSGA for both tacrolimus cream formulations were significantly higher (33.3% and 34.1%, respectively) than for the vehicle group (11.9%; P < .05).

Improvements in secondary efficacy measures supported the PSGA findings, according to the researchers.

The safety profile was comparable between groups. The most frequent adverse event was application site burning, reported by 11.9% of the placebo/vehicle group, 16.7% of the cream 0.1% group, and 13.6% of the cream 0.5% group.

"Other than nasopharyngitis [7.1 % for the 0.1% group and 6.8% for the 0.5% group], no other types of infections were observed in greater than or equal to 5% of patients in any treatment group," the authors noted.

Tacrolimus (Protopic) cream is currently FDA-approved for the treatment of moderate to severe atopic dermatitis.

The study was supported by Astellas Pharma Us, Inc.


[Presentation title: Efficacy and Safety of 0.1% and 0.5% Tacrolimus Cream Versus Vehicle for Treatment of Mild to Moderate Plaque Psoriasis in Adults. Poster 37]

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