Schmitt J, Schäkel K, Fölster-Holst R, Bauer A, Oertel R, Augustin M, Aberer W, Luger T, Meurer M
Prednisolone versus cyclosporine for severe adult eczema. An investigator-initiated double-blind placebo controlled multi-centre trial. [JOURNAL ARTICLE]
Br J Dermatol 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 cyclosporine is the best evaluated systemic treatment for eczema.
Objectives: To investigate the comparative efficacy of prednisolone and cyclosporine for severe eczema. Patients/
Methods: Investigator-initiated double-blind randomised multi-centre trial. adults with severe eczema (objective SCORAD >/=40 and DLQI >/=10) were randomly allocated to receive prednisolone (initial dose 0.5-0.8 mg/kg) for 2 weeks followed by placebo for 4 weeks or cyclosporine (4.0-2.7 mg/kg) 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 flair (>/=75% of baseline-SCORAD) within 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 unexpected high numbers of withdrawals due to significant exacerbations of eczema (n=15/38) an independent data monitoring and safety board proposed early study termination. 38 patients were randomised and analysed. Stable remission was achieved in 1 out of 21 patients receiving prednisolone compared to 6 out of 17 patients treated with cyclosporine (p=0.031).
Conclusions: Cyclosporine 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.
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