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


OBJECTIVE
(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.


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.
Thaçi
D
D
Department of Dermatology, Johann Wolfgang Goethe University, Frankfurt, Germany. thaci@em.uni-frankfurt.de
Bräutigam
M
M
Kaufmann
R
R
Weidinger
G
G
Paul
C
C
Christophers
E
E
D000287:Administration, Topical; D000328:Adult; D001830:Body Surface Area; D001835:Body Weight; D016572:Cyclosporine / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004655:Emulsions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D011788:Quality of Life; D012016:Reference Values; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004655:Emulsions; D016572:Cyclosporine