Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study

J Eur Acad Dermatol Venereol. 2008 Feb;22(2):195-203. doi: 10.1111/j.1468-3083.2007.02368.x.

Abstract

Background: Pimecrolimus cream 1% has been shown to effectively control atopic eczema (AE) when applied twice daily from the first signs or symptoms of AE until clearance. Moreover, pimecrolimus cream 1% has a favourable safety profile, lacking topical corticosteroid-related side-effects such as skin atrophy, making it particularly useful to treat delicate body regions (e.g. the face).

Objective: The objective of this naturalistic study was to monitor the safety, tolerability and efficacy of pimecrolimus when used in the long-term management of AE in a real-life setting.

Methods: A multicentre, open-label study was conducted in 2034 patients aged >or= 3 months with mild to moderate AE for up to 12 months' duration. Patients applied pimecrolimus cream twice daily, initiating treatment at first signs or symptoms of AE, continuing until clearance.

Results: Patients (n= 1847; 91%) completed 3 months of the study. Treatment success (clear or almost clear AE) after 3 months of treatment was observed on the whole body in 59% of patients and on the face in 81% of patients. Disease improvement of whole body and face was seen in 77% and 63% of patients, respectively. Pruritus was absent or mild in 79% of patients. Pimecrolimus cream was well tolerated throughout the study.

Conclusion: In a daily practice setting, pimecrolimus cream 1% effectively and safely controls AE.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / complications
  • Dermatitis, Atopic / drug therapy*
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Dose-Response Relationship, Drug
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Infant
  • Male
  • Ointments
  • Pruritus / drug therapy
  • Pruritus / etiology
  • Tacrolimus / administration & dosage
  • Tacrolimus / adverse effects
  • Tacrolimus / analogs & derivatives*
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Ointments
  • pimecrolimus
  • Tacrolimus