Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants.
BACKGROUND
Data on the efficacy of pimecrolimus cream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week.


OBJECTIVE
We sought to investigate the onset of action of pimecrolimus cream 1% in infants with mild to very severe atopic eczema.


METHODS
We used pimecrolimus cream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimus cream 1% for 12 weeks, with a 4-week follow-up period.


RESULTS
Pimecrolimus cream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle ( P < .001). The reduction in the Eczema Area and Severity Index with pimecrolimus cream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimus cream 1% by day 2 ( P < .03) and day 3 ( P = .002), respectively, compared with vehicle. Responses to pimecrolimus cream 1% were sustained during the open-label phase, and pimecrolimus cream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation.


CONCLUSIONS
Pimecrolimus cream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.
Kaufmann
Roland
R
Department of Dermatology and Venereology, Johann Wolfgang Goethe-Universität, Hautklinik, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. kaufmann@em.uni-frankfurt.de
Fölster-Holst
Regina
R
Höger
Peter
P
Thaçi
Diamant
D
Löffler
Helena
H
Staab
Doris
D
Bräutigam
Matthias
M
D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D009824:Ointments; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*
D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus