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Tacrolimus Ointment Safe and Effective in All Ages for Mild to Moderate Eczema: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 11, 2004 -- Tacrolimus ointment 0.03 (Protopic) appears to be safe and effective for mild to moderate atopic dermatitis in children and adults, researchers reported here on February 7^th at the American Academy of Dermatology 62^nd Annual Meeting.

"Data from these 2 identical studies show significant therapeutic value for tacrolimus for eczema when compared to placebo, and without significant adverse reactions," said co-investigator Mark Boguniewicz, MD, Professor, Division of Allergy-Immunology, Department of Pediatrics, National Jewish Medical and Research Center, Denver, Colorado, United States.

Investigators enrolled 599 subjects in the 2 identically designed 6-week, double blind, randomised, vehicle-controlled studies.

The subjects or their caregivers in the case of paediatric subjects applied tacrolimus or vehicle placebo ointment twice daily for up to 6 weeks. The researchers took safety and efficacy measures at baseline, on day 4, and weeks 2, 4 and end point.

Instruments measuring efficacy included the Investigator's Global Atopic Dermatitis Assessment, the Eczema Area and Severity Index (EASI), Assessment of Itch and Total Percent Body Surface Area affected.

To evaluate safety, the investigators used incidence of reported cutaneous adverse events, either by the patient, the caregiver or the physician.

Mean demographics and baseline disease characteristics were similar between groups.

"Of the patients who received tacrolimus, 50.0% achieved treatment success, compared to 28.3% of patients who received vehicle (P = .0001)."

Median change in EASI and end point for tacrolimus was -64.3 compared to -33.3 for vehicle (P = .0001). Median percent change in Assessment of Itch at end point was -71.3 compared to -31.0 for vehicle (P = .0001). Median change at endpoint for affected body surface area was -63.6 for tacrolimus and -25.0 for vehicle (P = .0001).

Skin burn/stinging rates were similar for both groups (28.1% for tacrolimus and 25.7% for vehicle, P = .51) with itching reported at a significantly higher rate among vehicle subjects than tacrolimus subjects (38.9% versus 29.4%, respectively, P = .01). Skin erythema was also reported at a significantly higher rate among vehicle than tacrolimus subjects (25.0% and 13.2%, respectively, P = .002). Other adverse event rates were negligible for both groups, the authors noted.

Tacrolimus ointment 0.003 is currently approved in the United States as a short-term and intermittent long-term therapy to treat the signs and symptoms of moderate to severe eczema (atopic dermatitis) in children and adults.


[Study title: Tacrolimus Ointment 0.03 Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric and Adult Patients. Abstract P11]

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