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


OBJECTIVE
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 > or = 40 and Dermatology Life Quality Index > or = 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. > or = 50% SCORAD improvement under active treatment and no flare (> or = 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.
Department of Dermatology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany. jochen.schmitt@uniklinikum-dresden.de
J
J
Schmitt
K
K
Schäkel
R
R
Fölster-Holst
A
A
Bauer
R
R
Oertel
M
M
Augustin
W
W
Aberer
T
T
Luger
M
M
Meurer
D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects*; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004485:Eczema / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects*; D013223:Statistics as Topic; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D016572:Cyclosporine; D011239:Prednisolone