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Clinical Trial
. 2002;205(4):383-8.
doi: 10.1159/000066425.

Body-weight-independent dosing of cyclosporine micro-emulsion and three times weekly maintenance regimen in severe psoriasis. A randomised study

D Thaçi  1 , M Bräutigam, R Kaufmann, G Weidinger, C Paul, E Christophers
Affiliations
Clinical Trial

Body-weight-independent dosing of cyclosporine micro-emulsion and three times weekly maintenance regimen in severe psoriasis. A randomised study

D Thaçi et al. Dermatology. 2002.

Abstract

Background: Body-weight-dependent (BWD) treatment of psoriasis with cyclosporine A (CsA is well established. It has recently been reported that this is not necessary for the treatment of atopic dermatitis.

Objectives: (1) To investigate the efficacy and safety of a CsA micro-emulsion administered in a new body-weight-independent (BWI) protocol and to compare it to a BWD dosage regimen in the treatment of severe psoriasis. (2) To investigate the duration of disease remission after intermittent treatment of psoriasis with CsA.

Patients and methods: 122 adult patients with severe plaque-type psoriasis (PASI > or = 12) were included in this study which consisted of two treatment periods: period I was a randomised parallel-group comparison of daily CsA doses of 100-300 mg (BWI) or 1.25-5.0 mg/kg (BWD) for 12 weeks; period II was a randomised double-blind placebo-controlled extension treatment of patients, who had responded (>75% PASI recovery) to the treatment in period I and continued the treatment on their last effective dose or placebo 3 times weekly for a further 12 weeks.

Results: In period I, the increase in creatinine in the BWI group (2.7 micromol/l) was proven to be non-inferior to that of the BWD group (3.5 micromol/l) at a non-inferiority limit of 5 micromol/l (p < 0.05). The PASI decreased with BWI dosing from 22.0 to 3.0 and with the BWD scheme from 19.5 to 2.5 (p = 0.98). In period II, the relapse rates were 40.5% (17/42) with intermittent CsA and 56.9% (29/51) with placebo (p = 0.15).

Conclusions: BWI dosing is as effective and safe as conventional BWD dosing for the short-term treatment of severe psoriasis. There was a tendency toward a prolongation of remission with intermittent CsA treatment.

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