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

摘要: 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 treatment for eczema. Objectives To investigate comparative Methods In an investigator-initiated double-blind randomized multicentre trial, adults (objective SCORAD > or = 40 Dermatology Life Quality Index 10) were randomly allocated to (initial dose 0.5-0.8 mg kg(-1) daily) 2 weeks followed by placebo 4 (2.7-4.0 6 another 12 weeks. Concomitant included a moderately potent topical steroid, emollients, continuation antihistamines. Primary endpoint was proportion patients stable remission, i.e. 50% improvement under active no flare (> 75% baseline SCORAD) during follow-up. Sample size calculation 66 needed see clinically relevant differences between groups. Analysis intention-to-treat (ClinicalTrials.gov Identifier: NCT00445081). Results Because unexpectedly high numbers withdrawals due significant exacerbations (n 15/38) independent data monitoring safety board proposed early study termination. Thirty-eight analysed. Stable remission achieved in one 21 receiving compared six 17 treated (P 0.031). Conclusions Ciclosporin significantly more efficacious than adult Despite its frequent use daily practice, not recommended induce