A randomized, double-blind, multicentre study was performed to compare the efficacy of acitretin (50 mg/day) with hydroxychloroquine (400 mg/day) in 28 and 30 patients, respectively, suffering from cutaneous lupus erythematosus (LE). The study was carried out over an 8-week period. Improvement of facial LE lesions after treatment with acitretin and hydroxychloroquine was assessed using several clinical parameters. In the acitretin group there was marked improvement or clearing of erythema in 10/24 patients (42%), of infiltration in 15/24 (63%) and of scaling/hyperkeratosis in 12/20 (60%). In the hydroxychloroquine group there was complete clearing or marked improvement of erythema in 17/25 patients (68%), of infiltration in 17/25 (68%) and of scaling/hyperkeratosis in 15/23 (65%). Overall improvement occurred in 13/28 patients (46%) treated with acitretin and in 15/30 patients (50%) with hydroxychloroquine. The incidence of side-effects was higher in the acitretin group, and necessitated discontinuation of treatment in four patients. The present results demonstrate that both acitretin and hydroxychloroquine provide effective treatment in approximately 50% of cases of cutaneous LE.

Compared with the antipsoriatic retinoid etretinate, the new aromatic retinoid acitretin represents an important advance due to its rapid elimination kinetics. Since in psoriasis vulgaris retinoids are used predominantly in combination regimens, we investigated the therapeutic efficacy of acitretin and UV-B compared with placebo and UV-B in a double-blind, randomized multicenter trial in 82 patients with severe psoriasis. They were treated with 35 mg of the study medication during the first 4 weeks of therapy and 25 mg thereafter, concomitantly with UV-B irradiation in increasing energy doses. Forty patients who underwent therapy with acitretin and UV-B and 38 patients who underwent therapy with placebo and UV-B were evaluated for efficacy. The target variables--psoriasis severity index and total UV-B dose--were reported at intervals of 2 weeks over a maximum period of 8 weeks. At the end of treatment, the psoriasis severity index decrease was 79% in the acitretin and UV-B group and 35% in the placebo and UV-B group. The response rate, defined as greater than or equal to a 75% decrease of the psoriasis severity index, was 60% for the combination treatment and only 24% for the control treatment. This treatment response was achieved with markedly lower cumulative UV-B energy. The median cumulative UV-B energy applied to reach 75% clinical improvement was 11.8 J/cm2 vs 6.9 J/cm2. Side effects showed a similar pattern in both groups. Our data show that the acitretin dramatically improves the results of UV-B treatment in patients with severe psoriasis. In addition, it markedly decreases the effective cumulative UV-B dose, thereby reducing the potential long-term hazards of UV irradiation. We conclude that the acitretin plus UV-B combination treatment represents a highly effective therapeutic regimen in severe psoriasis.

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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