An open-label multicenter study to evaluate the efficacy and safety of elidel (Pimecrolimus) cream 1 percent in patients >/- 3 months of age with mild or moderate atopic dermatitis .

Objective: To evaluate the safety and efficacy of pimecrolimus (Elidel) in its registered indication, that is, for the treatment of patients >/- 3 months of age with mild or moderate atopic dermatitis.

Patients and Methods

Study Design: This is an open-label, multi-center, single-arm Phase IV study.

Number of patients: Two hundred eighty three patients with atopic dermatitis (AD) were enrolled in 14 centers.

Inclusion and exclusion criteria: Male or female patients, age >/- 3 months with mild or moderate AD, and a whole body Investigators Global Assessment (IGA) of >/- 1 were enrolled in the study. Patients with active viral infections at the site(s) of treatment, those with systemic malignancy or active lymphoproliferative diseases/disorders, received phototherapy or immunosuppressive therapy, had used tacrolimus ointment and had known allergy or hypersensitivity to pimecrolimus or any components of the cream, were excluded from the study.
Duration of treatment: Three months treatment, as needed
Main outcome variables: Efficacy variables included Investigator's Global Assessment (IGA) score for the whole body, Facial Investigator Global Assessment (FIGA) specific for the face, pruritus severity assessments (PSA) and subject's assessment of diseases control measured at baseline (Visit 1) and subsequently, 7 days (Visit 2), 30 days (Visit 3) and 90 days (Visit 4) after treatment initiation. The occurrence of adverse events (AEs) and serious adverse events (SAEs) were used for safety assessments.

Analysis: The efficacy scores were tabulated at each visit. Chi-square test was used to determine significant changes in the distribution of efficacy scores. Incidence of adverse events was calculated. Intention-to-treat analysis among patients who receive at least one application of pimecrolimus cream 1 percent (Elidel) was performed.

Results

Efficacy: The changes in IGA and FIGA scores of patients during the three follow-up visits as compared with baseline were statistically significant. Clearing of skin, pruritus, and sleep disturbance were all significantly improved.

Safety: The adverse events (AE) were mild and transient. Only 19 patients (7.0%) reported at least one AE during the 3-month study period which were considered to be related to the study medication. Four serious adverse events (1.0 percent) were reported. Causality was assessed by investigators as not suspected or not related to pimecrolimus (Elidel).

Conclusion: This 3-month study showed the efficacy of pimecrolimus (Elidel) cream in addressing the immediate needs of patients with mild to moderate atopic dermatitis, that is, it is a very effective in quickly controlling pruritus and eczema. Adverse effects related to drug use were minimal and improved with continued use of cream. (Author)