Conflicts of interest J.S., K.S., R.F.-H., A.B., R.O., M.A., W.A. and T.L.: none declared. M.M.: although not directly related to this study, M.M. has served as a consultant and as a paid lecturer for Novartis.
Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial
Version of Record online: 26 OCT 2009
© 2009 The Authors. Journal Compilation © 2009 British Association of Dermatologists
British Journal of Dermatology
Volume 162, Issue 3, pages 661–668, March 2010
How to Cite
Schmitt, J., Schäkel, K., Fölster-Holst, R., Bauer, A., Oertel, R., Augustin, M., Aberer, W., Luger, T. and Meurer, M. (2010), Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial. British Journal of Dermatology, 162: 661–668. doi: 10.1111/j.1365-2133.2009.09561.x
- Issue online: 15 FEB 2010
- Version of Record online: 26 OCT 2009
- Accepted for publication 16 October 2009
- atopic dermatitis;
- randomized controlled trial
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.