Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants - 24/08/11
, Regina Fölster-Holst, MD b, Peter Höger, MD c, Diamant Thaçi, MD a, Helena Löffler, MD d, Doris Staab, MD e, Matthias Bräutigam, PhD d
Reprint requests: Roland Kaufmann, MD, Johann Wolfgang Goethe University Hospital, Department of Dermatology and Venereology, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.for the CASM981CDE04-Study Group
Frankfurt am Main, Kiel, Hamburg, Nürnberg, and Berlin, Germany
Abstract |
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.
Conclusion |
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.
Le texte complet de cet article est disponible en PDF.Key words : Pimecrolimus, infants, atopic eczema, dermatitis
Abbreviations used : EASI, IGA
Plan
| Supported by Novartis Pharma GmbH. Conflict of interest statement: The following have a financial interest-relationship as follows. R. Kaufmann: grant-research support from Amgen, Aventis, Basilea, Biofrontera, Biogen, Centocor, Fumapharm, Fujisawa, Galderma, Genmab, Henkel, Hermal, Infectopharm, Leo, Medigene, Medimmune, Novartis, Schering, Schering-Plough, Serono, Smith & Nephew, and Versicor. D. Thaçi: grant-research support from Amgen, Aventis, Basilea, Biofrontera, Biogen, Centocor, Fumapharm, Fujisawa, Galderma, Genmab, Henkel, Hermal, Infectopharm, Leo, Medigene, Medimmune, Novartis, Schering, Schering-Plough, Serono, Smith & Nephew, Versicor; lecture honoraria from Novartis, Biogen, Fumedica, Hermal, Leo; consultant for Novartis and Fujisawa. R. Fölster-Holst: grant-research support from Novartis, Fujisawa, Hartmann and Stallergen; lecture honoraria from Novartis and Fujisawa; consultant for Novartis. P. Höger: grant-research support from Novartis; consultant for Novartis. D. Staab: grant-research support from Novartis and Fujisawa; lecture honoraria from Novartis. H. Löffler and M. Bräutigam are employees of Novartis Pharma GmbH. |
Vol 114 - N° 5
P. 1183-1188 - novembre 2004 Retour au numéro
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