Objectives To investigate the therapeutic efficacy of acitretin + PUVA compared to placebo + PUVA in terms of improvement assessed by the Psoriasis Severity Index {PSD and total UVA dosage. Design Double-blind, randomized, parallel, multicenter study over 8 weeks. Indication Generalized chronic plaque or exanthematie type of psoriasis severe enough to require PUVA treatment. Targets Decrease of PSI at the end of the study; response defined as improvement of PSI > 75% with respect to baseline, total UVA dosage applied and UVA dosage applied up to response. Statistical methods PSI changes (baseline up to end of treatment) in the two groups were compared at the 5% significance level using the Kolmogoroff-Smirnoff test (2-tailed). In addition, descriptive statistics for comparison of response rates (Chi" test) and total UVA dosage as well as UVA dosage applied up to response (life-table analysis by Kaplan-Meier) were performed. Results Patients Forty patients (36 males, 4 females) in the acitretin + PUVA and 43 patients (32 males, 11 females) in the placebo -I-PUVA group were investigated for efficacy. Twentythree patients of the aeitretin + PUVA group and 25 patients of the placebo -I-PUVA group ceased treatment prematurely. PSI The median PSI decrease was 24 (89%) score points in the acitretin + PUVA group and 21 (83%) in the placebo + PUVA group (/*> 0.05, KolmogoroffSmirnoff test). The response rate was 34 out of 40 (85%; 95% CI 70-94%) in the acitretin + PUVA group and 26 out of 43 (60%; 95% CI 44-75%) in the placebo + PUVA group (P ^ 0.013, Chi^ test: descriptive). Complete remission The clinical outcome as assessed by the investigator was complete remission in 28 patients of the acitretin -I-PUVA group and 19 patients of the plaeebo + PUVA group. Premature discontinuation of treatment due to complete remission was possible in 16 patients of the acitretin -I-PUVA group and 11 patients of the placebo -I-PUVA group. UVA dosage The total UVA dose applied was 77.6 J/cm( SEM = 9.2 J/cm-) in the acitretin + PUVA group and 73.0 J/cm-(SEM = 7.2 J/cm^) in the placebo + PUVA group. The median UVA dose up to response was 52.0 J/cm^ in the acitretin -I-PUVA group and 74.5 J/cm^ in the placebo -I-PUVA group. Tolerability In both treatment groups, adverse events were frequent. Mucocutaneous adverse events, such as dry lips, mouth and nose and dryness and scaling of the skin, were the most common complaints in both groups, but more pronounced in the acitretin 4-PUVA group. Treatment of adverse events included mainly indifferent ointments, non-steroidal, anti-inflammatory drugs and anti-puritic agents and tranquillzers. Treatment had to be discontinued due to adverse events in three patients of each group. In the acitretin + PUVA group, the reasons were acral-bullous photodermatosis due to PUVA, increased liver enzymes and increased triglycerides, respectively. In the placebo + PUVA group, one patient developed sensori-neural loss of hearing, one stomach pain, nausea and colics of the upper abdomen and one increased triglyceri...
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