Sustained Efficacy and Safety of Pimecrolimus Cream 1% When Used Long-term (up to 26 Weeks) to Treat Children With Atopic Dermatitis
Langley RG, Eichenfield LF, Lucky AW, Boguniewicz M, Barbier N, Cherill R. Pediatr Dermatol. 2008;25(3):301–307
PURPOSE OF THE STUDY. To evaluate the efficacy and safety of pimecrolimus cream 1% (Elidel [Novartis, East Hanover, NJ]) used for 26 weeks in children with atopic dermatitis (AD)
STUDY POPULATION. This was a prospective study of 403 children aged 2 to 17 years with AD (mean age at enrollment: 6.7 years) recruited from multiple academic centers in the United States.
METHODS. Pooled data were assessed from 20-week, open-label (OL) extensions of 2 previously reported 6-week, double-blind (DB) phase studies in which patients were randomly assigned 2:1 to pimecrolimus or vehicle. During the OL phase, all patients were treated with pimecrolimus. During the DB phase, no other AD treatments except emollients were allowed. The efficacy parameters included the Investigator's Global Assessment (IGA), Eczema Area and Severity Index, and severity of pruritus scores. Safety assessment consisted primarily of monitoring adverse events. Patients were evaluated on days 8, 15, 22, 29, 43, 71, 99, 141, and 183.
RESULTS. Overall, 60.3% of the patients had moderately severe AD (IGA: 3) at study entry. Twice as many in the control group discontinued during the DB phase compared with the treated group (25% vs 11.4%). The main reason for the higher discontinuation rate in the control group was unsatisfactory therapeutic effect (15.4% vs 2.6%). Eighty-four percent completed the OL phase with similar rates of completion between the groups. At day 43, 34.8% of the pimecrolimus-treated patients versus 18.4% in the vehicle groups (P < .001) had clear or almost clear (IGA: 0 or 1) disease. Pimecrolimus was significantly more effective (P < .0001) in treating the face and neck compared with the body during both DB and OL phases. In the pimecrolimus group, 56.5% of the patients had mild or absent pruritus by day 43 compared with 33.8% of those in the control group. The incidence of adverse events, including infections and complaints of a burning sensation with application, was not statistically different between groups during either phase of the study.
CONCLUSIONS. Treatment of AD with pimecrolimus was effective, particularly for the face and neck areas, and well tolerated.
REVIEWER COMMENTS. Given the black-box warning and concern with using topical calcineurin inhibitors, this article reemphasized that pimecrolimus is efficacious for children with AD. Particularly, it should be considered for use on the face and neck, which are difficult to treat with higher potency topical corticosteroids because of the risk of local adverse effects such as atrophy. The minimal adverse events associated with pimecrolimus support previous studies that had longer durations of treatment (up to 2 years).
- Copyright © 2008 by the American Academy of Pediatrics