Prednisolone vs. Ciclosporin for Severe Adult Eczema. An Investigator-Initiated Double-Blind Placebo-Controlled Multicentre Trial

Br J Dermatol. 2010 Mar;162(3):661-8. doi: 10.1111/j.1365-2133.2009.09561.x. Epub 2009 Oct 26.

Abstract

Background: Patients with severe eczema frequently receive systemic glucocorticosteroids. The efficacy of prednisolone and other steroids, however, has never been evaluated appropriately. A meta-analysis indicated that ciclosporin is the best evaluated systemic treatment for eczema.

Objectives: To investigate the comparative efficacy of prednisolone and ciclosporin for severe eczema.

Methods: In an investigator-initiated double-blind randomized multicentre trial, adults with severe eczema (objective SCORAD > or = 40 and Dermatology Life Quality Index > or = 10) were randomly allocated to receive prednisolone (initial dose 0.5-0.8 mg kg(-1) daily) for 2 weeks followed by placebo for 4 weeks or ciclosporin (2.7-4.0 mg kg(-1) daily) for 6 weeks and followed for another 12 weeks. Concomitant treatment included a moderately potent topical steroid, emollients, and continuation of antihistamines. Primary endpoint was the proportion of patients with stable remission, i.e. > or = 50% SCORAD improvement under active treatment and no flare (> or = 75% of baseline SCORAD) during follow-up. Sample size calculation indicated that 66 patients were needed to see clinically relevant differences between groups. Analysis was by intention-to-treat (ClinicalTrials.gov Identifier: NCT00445081).

Results: Because of unexpectedly high numbers of withdrawals due to significant exacerbations of eczema (n = 15/38) an independent data monitoring and safety board proposed early study termination. Thirty-eight patients were randomized and analysed. Stable remission was achieved in one of 21 patients receiving prednisolone compared with six of 17 patients treated with ciclosporin (P = 0.031).

Conclusions: Ciclosporin is significantly more efficacious than prednisolone for severe adult eczema. Despite its frequent use in daily practice, prednisolone is not recommended to induce stable remission of eczema.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / adverse effects*
  • Cyclosporine / administration & dosage
  • Cyclosporine / adverse effects*
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Double-Blind Method
  • Eczema / drug therapy*
  • Female
  • Humans
  • Male
  • Prednisolone / administration & dosage
  • Prednisolone / adverse effects*
  • Statistics as Topic
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Cyclosporine
  • Prednisolone

Associated data

  • ClinicalTrials.gov/NCT00445081