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Keywords:

  • adults;
  • atopic dermatitis;
  • ciclosporin;
  • prednisolone;
  • randomized controlled trial

Summary

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 (= 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 (= 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.