New Study Shows Elidel Provides Effective Management of Eczema Flare-Ups

Long-term intermittent treatment with Elidel Cream 1 percent in both adult and pediatric patients provided control of the symptoms associated with atopic dermatitis, commonly known as eczema, for up to 18 months, according to new study results announced during the 63rd annual meeting of the American Academy of Dermatology in New Orleans.

The objective of this multinational study was to evaluate the long-term safety and effectiveness of Elidel (pimecrolimus) in pediatric and adult patients with eczema of any severity, who had previously completed a six-month 947-patient core study. The extension study included 368 of those patients who remained in the study and were treated for up to 18 months. Patients were enrolled at 61 centers in 10 countries.

During the extension phase of the study, Elidel was incorporated as needed into patients' daily treatment routines as follows: Patients applied Elidel twice daily to affected areas beginning at the earliest signs or symptoms of a flare (e.g., tingling or itching), and continued for as long as the flare persisted. Any time signs or symptoms returned, patients resumed twice-daily treatment, in effort to prevent progression. Patients were not required to see their doctor before resuming treatment for a flare. However, emollients and topical corticosteroids could be added to the treatment regimen, if the treating physician felt it was warranted.

There were no unexpected safety findings. The most common adverse events (occurring in 5 percent of patients or more) were infections (nasopharyngitis 13.9 percent, upper respiratory tract infection 6.4 percent, influenza 6.1 percent), respiratory disorders (16.9 percent), application-site conditions (10 percent) and headache (8 percent). The overall incidence of viral infections was less than 1 percent. Treatment-related herpes simplex occurred in four patients (1.1 percent). The incidence of adverse events decreased from the end of the core study to the end of the extension study. Application-site burning, pruritus and impetigo all became less frequent in the extension study.