Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

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 ≥ 40 and Dermatology Life Quality Index ≥ 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. ≥ 50% SCORAD improvement under active treatment and no flare (≥ 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.

Details

Original languageEnglish
Pages (from-to)661-668
Number of pages8
JournalBritish journal of dermatology
Volume162
Issue number3
Publication statusPublished - Mar 2010
Peer-reviewedYes

External IDs

PubMed 19863501
ORCID /0000-0002-4411-3088/work/166764111
ORCID /0000-0003-1526-997X/work/166764212

Keywords

ASJC Scopus subject areas

Keywords

  • Adults, Atopic dermatitis, Ciclosporin, Prednisolone, Randomized controlled trial