A multicentre evaluation of the guidelines for the use of cyclosporin A in severe psoriasis

Background. Controversy still exists as to whether a dosage scheme for the treatment of severe psoriasis with cyclosporin A (CsA) should start with low dosages (3 mg/kg/day) or rather with high dosages (5 mg/kg/day). Aims. In this open prospective multi-centre trial guidelines for the use of CsA in psoriasis beginning with low dosages were evaluated. A secondary aim of the study was to elucidate factors predicting efficacy of CsA treatment. Methods. Efficacy and tolerability of CsA were evaluated monthly during 16 weeks in 86 patients (56 males, 30 females, mean age 43.0 ± 14.9 years) suffering from chronic severe plaque-type psoriasis, not responding to topical therapy (mean PASI 18.0 ± 8.1). All patients started with 3 mg/kg/day. Patients were defined as responders with a PASI reduction ≤ 25% at month 1, ≤ 50% at month 2, ≤ 60% at month 3 and ≤ 70% at month 4. When a patient was a failure, the dose was increased by 1 mg/kg/day to a maximum of 5 mg/kg/day. Results. A gradual mean PASI reduction of 38%, 59%, 72% to 76% was reached with a mean CsA dose of 1 3.0, 3.2, 3.5, and 3.6 mg/kg/day at weeks 4, 8, 12 and 16, respectively. At the end of the study period, 39 patients were still on 3, 24 patients were on 4 and 15 patients were on 5 mg/kg/day. Due to subjective side-effects 6 patients dropped out on 3 mg/kg/day and 2 on 4 mg/kg/day. Diastolic and systolic blood pressure and creatinine levels were stable. Overall, CsA was relatively well tolerated. Absence of previous therapies, low baseline PASI and failure at week 4 were predictive-for higher drop-out and failure rate and lower PASI at the end of study. Conclusions. This study shows that a significant proportion of severe psoriasis patients can be treated with 3 mg/kg/day CsA with good tolerability and excellent clinical results. It is concluded that a treatment scheme with an optimal risk-benefit ratio should start with low dosages of CsA (3 mg/kg/day).