Efficacy

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One systematic review of ciclosporin for severe psoriasis has been published (search date 1999,

18 RCTs, 2240 people).59 One additional as yet unpublished RCT was identified.

Versus placebo for induction of remission

Different dosage regimens for induction of remission have been compared with placebo in nine intervention groups in five RCTs (n = 289). A dose of 1-25 mg/kg/day was ineffective whereas 5 mg/kg/day appeared to be more effective than 2-5 mg/kg/day. Higher doses appeared to give little extra benefit.

Comparison of dosage schedules for induction of remission

The superiority of 5 mg/kg/day over 2-5 mg/kg/ day was confirmed in two RCTs (n = 432). In the larger of these (n = 251), 92% of people receiving the higher dose were judged to have responded satisfactorily, compared with only 52% on the lower dose.60

Versus placebo for maintenance of remission

Two RCTs (n = 202) examined low (1-25 mg/kg/ day) and intermediate (3-0 mg/kg/day) dose schedules for maintenance of remission induced by ciclosporin. The higher dose was required to achieve superiority over placebo, although even then only 57% and 58% of people continuing therapy for 16 or 24 weeks, respectively, were considered to have remained in remission. Since the definitions of remission used in these studies allowed for relapse to up to 50% of the pretreatment disease extent, it may be difficult to maintain acceptable levels of control with ciclosporin alone at these relatively low doses.61,62

Comparison of drug formulations

In 1995 a new formulation of ciclosporin (Neoral) was introduced to improve reliability of gastrointestinal absorption. Two RCTs (n = 345) found no difference in efficacy at 12 weeks between Neoral and its precursor Sandimmun, although the new formulation may have had a more rapid onset of action.63

Versus etretinate

Two RCTs (n = 286) concluded that etretinate was less effective than ciclosporin at inducing remission of psoriasis within 10 to 12 weeks.64,65

Versus methotrexate

One RCT (n = 85) compared various dose regimens of methotrexate 15-22-5 mg weekly and ciclosporin 3-5 mg/kg/day for 12 weeks followed by tapered withdrawal to 16 weeks (Spuls P, International Psoriasis Symposium, San Francisco, June 2001, personal communication). There was no significant difference in response at 16 weeks, although ciclosporin appeared to act more rapidly.

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