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.
Schmitt
J
J
Department of Dermatology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany. jochen.schmitt@uniklinikum-dresden.de
Schäkel
K
K
Fölster-Holst
R
R
Bauer
A
A
Oertel
R
R
Augustin
M
M
Aberer
W
W
Luger
T
T
Meurer
M
M
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