Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis

Dermatology. 2004;208(4):365-72. doi: 10.1159/000078462.

Abstract

Background: Pimecrolimus cream 1% is a non-steroid, selective inflammatory cytokine inhibitor indicated for atopic dermatitis (AD).

Objective: To compare the safety and efficacy of pimecrolimus cream 1%-based treatment versus conventional therapy in adults with moderate AD.

Methods: Patients were randomized to receive pimecrolimus cream 1% (n = 62) or vehicle (n = 68) at the first signs/symptoms of AD, for 24 weeks as required. A moderately potent topical corticosteroid (prednicarbate 0.25% cream) was allowed in both groups to treat flares.

Results: Corticosteroids were required on fewer days in the pimecrolimus group, compared with the vehicle group (9.7 vs. 37.8%, p < 0.001). Furthermore, 59.7% of pimecrolimus-treated patients experienced no flares during the study period, compared with 22.1% of vehicle-treated patients (p < 0.001). Pimecrolimus cream 1% was well tolerated throughout the study.

Conclusion: For adults with moderate AD, pimecrolimus cream 1% is well tolerated, reduces the incidence of flares, reduces/eliminates corticosteroid use, improves long-term disease control and enhances the patients' quality of life.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Dermatitis, Atopic / drug therapy*
  • Dermatitis, Atopic / pathology
  • Dermatologic Agents / administration & dosage*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Tacrolimus / administration & dosage*
  • Tacrolimus / analogs & derivatives*
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • pimecrolimus
  • Tacrolimus