Tacrolimus Benefits a Broad Span of Atopic Dermatitis Patients: Presented at EADV

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Title: Tacrolimus Benefits a Broad Span of Atopic Dermatitis Patients: Presented at EADV
URL: http://www.pslgroup.com/dg/22CCB6.htm
Doctor's Guide
September 19, 2008

By Jill Stein

PARIS -- September 19, 2008 -- Tacrolimus ointment is effective for the management of atopic dermatitis (AD) in both adult and paediatric patients, including those previously treated with topical corticosteroids, investigators reported here at the 17th European Academy of Dermatology and Venereology (EADV) Congress.

Eileen Jaracz, PharmD, Astellas Pharma US, Inc., Deerfield, Illinois, and colleagues presented on September 18 the results of a study in 347 patients with AD and were treated with topical corticosteroids in the 30 days prior to enrolment in 3 multicentre, randomised, 6-week trials.

Paediatric patients with mild AD were randomised to tacrolimus ointment 0.03% or pimecrolimus cream 1.0%. Paediatric patients with moderate to very severe AD and adults with mild to very severe AD were randomised to tacrolimus ointment 0.1% or pimecrolimus cream 1.0%.

All participants met the Hanifin and Rajka clinical criteria for the diagnosis of AD, had disease over at least 5% of their total body surface area (BSA), and had disease severity ranging from mild to very severe according to the Investigator Global Atopic Dermatitis Assessment (IGADA).

Patient demographics and baseline characteristics were similar between the 2 treatment groups.

At the end of the trial, the percent improvement in Eczema Activity Severity Index score from baseline was significantly greater for all patients treated with tacrolimus ointment compared with those treated with pimecrolimus cream (mean percent improvement of 53.2% vs 33.7%, respectively, P = .0002).

Significantly more patients treated with tacrolimus ointment achieved therapy success (defined as "clear" or "almost clear" by IGADA score) at the end of therapy than did patients treated with pimecrolimus cream (36.8% vs 20.5%; P = .0007).

Also, in a comparison of the IGADA scores at enrolment and at the end of the trial, significantly more patients assigned to tacrolimus ointment than pimecrolimus cream improved by 1 or more grades on the IGADA (60.2% vs 39.8%, respectively; P = .0006).

In addition, the percentage of patients that showed improvement in BSA affected from baseline to the end of the study was significantly greater with tacrolimus ointment than with pimecrolimus cream (53.6% vs 36.2%, respectively; P = .002).

Itch, as quantified by Visual Analogue Scale, was significantly improved in the tacrolimus compared with the pimecrolimus group (2.9 vs 3.9 cm; P = .002).

Tacrolimus ointment and pimecrolimus cream had similar safety profiles, the researchers reported.

Funding for the study was provided by Astellas Pharma US, Inc.

[Presentation title: The Safety and Efficacy of Tacrolimus Ointment and Pimecrolimus Cream in the Treatment of Atopic Dermatitis Patients Previously Treated With Corticosteroids: A Subset Analysis of 3 Multicenter, Randomized, Blinded Therapeutic Trials. Abstract FP0074]

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