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Pimecrolimus Cream 1% Safe and Effective for Atopic Dermatitis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 7, 2007 -- Pimecrolimus cream 1% (Elidel) is safe and effective in the daily practice of treating atopic dermatitis, according to results from the Elidel Patient Self-Observation (El Paso) study.

The findings were presented here in a poster session on February 3^rd at the 65^th annual meeting of the American Academy of Dermatology (AAD).

At the end of treatment, 67.3% of patients rated the pimecrolimus cream 1%-based therapy as better than their previous treatments, the investigators reported in their poster presentation.

Thomas Luger, MD, chairman, department of dermatology, University of Muenster, Muenster, Germany, and colleagues conducted the 15-week multi-center patient self-observation study to assess the safety and efficacy of a pimecrolimus cream 1%-based treatment in daily medical practice among patients with atopic dermatitis.

A total of 3,502 patients (62% female) aged 4 months to 85 years (mean 26.2 +/- 18.0 years) were recruited by 810 physicians in Germany. The study design allowed subjects to use concomitant medications (including topical and systemic corticosteroids, systemic antihistamines, emollients).

Subjects were evaluated at clinic visits at the start of treatment, two optional visits during the 15-week observation period and at the end of treatment. A 6-point scale evaluated overall disease severity and individual symptoms (excoriation, pruritus, lichenification).

Physicians evaluated overall safety and efficacy of treatment at the end of 15 weeks using patients' daily records and study visit records. Adverse events were tracked throughout the study.

Daily records were obtained from 2,985 patients. Complete data (records from all study visits and patients daily records) were available for 1,220 patients.

The percentage of patients with severe or very severe AD decreased from 25% at baseline to 7% at end of treatment. The percentage of patients with symptoms or mild symptoms increased from 9% to 55%.

A decrease in the prevalence and intensity of erythema and pruritus as well as a decrease of cases with lichenification and excoriation were also observed.

Efficacy of pimecrolimus 1% cream treatment was rated as "good" or "very good" for 83.5% of cases by the attending physicians and by 79% of patients.

Overall tolerability of pimecrolimus 1% cream treatment was rated as "good" or "very good" for 91% of cases by attending physicians and by 87% of patients.

Adverse events (irritation, pruritus, redness and worsening of disease) were observed in 220 of 3502 subjects (6.3%).

The authors concluded, "Pimecrolimus cream 1% for the treatment of [atopic dermatitis] in daily practice has demonstrated a good safety profile and effectiveness as judged by physicians and patients in this open patient-self-observation study."

The study was supported by Novartis Pharma.


[Presentation title: Safety and efficacy of pimecrolimus cream 1% in the daily practice - results of the Elidel Patient Self-Observation (El Paso) study in 3502 patients with atopic dermatitis in Germany. Poster 726]

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