Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Schmitt, J; Schäkel, K; Fölster-Holst, R; Bauer, A; Oertel, R; Augustin, M; Aberer, W; Luger, T; Meurer, M.
Prednisolone vs. ciclosporin for severe adult eczema. An investigator-initiated double-blind placebo-controlled multicentre trial.
Br J Dermatol. 2010; 162(3): 661-668.
Doi: 10.1111/j.1365-2133.2009.09561.x
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- Co-Autor*innen der Med Uni Graz
- Aberer Werner
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- Abstract:
- Background Patients with severe eczema frequently receive systemic glucocortico-steroids. 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.govIdentifier: 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Anti-Inflammatory Agents - administration and dosage
- Cyclosporine - administration and dosage
- Dermatologic Agents - administration and dosage
- Double-Blind Method -
- Eczema - drug therapy
- Female -
- Humans -
- Male -
- Prednisolone - administration and dosage
- Statistics as Topic -
- Treatment Outcome -
- Young Adult -
- Find related publications in this database (Keywords)
- adults
- atopic dermatitis
- ciclosporin
- prednisolone
- randomized controlled trial