CYCLOSPORINE IN ATOPIC-DERMATITIS - A MULTICENTER PLACEBO-CONTROLLED STUDY

The efficacy of cyclosporin (Sandimmun(R)) given in a daily dose of 5 mg/kg for 6 weeks in severe atopic dermatitis was confirmed in this do uble-blind, placebo-controlled, short-term study. Of the 46 patients i ncluded in the study, 23 were randomized to receive cyclosporin and 23 to receive placebo. Four of the 23 patients (17%) on cyclosporin, and 14 of the 23 patients (61%) who received placebo, discontinued the tr ial because of inefficacy. All patients who discontinued the trial wer e assessed following the principle of 'intention to treat'. Compared w ith the baseline, the mean scores for disease severity [6-area, total body severity assessment (TBSA)] improved by 55%, and the mean scores for extent of disease [rule-of-nines area assessment (RoNAA)] improved by 40%, in patients treated with cyclosporin. Nine of the patients wh o received cyclosporin and completed the study (n = 14) had an individ ual reduction of disease severity (TBSA) of 75% or more, and in three patients this reduction was nearly 100%. In the placebo group, a mean worsening of disease severity (4%) and of extent of the disease (25%), compared with the baseline, was observed at week 6. Patients' and inv estigators' mean scores for the overall efficacy were similar, and sho wed a statistically significant difference in favour of cyclosporin. T wo patients on cyclosporin developed hypertension during therapy, and one of these withdrew from the study. At the end of the trial, no stat istically significant differences in the systolic or diastolic blood p ressures were observed between the two groups. In the cyclosporin grou p, the increases in the values of serum creatinine and bilirubin at we ek 6, compared with the respective values at the baseline, were statis tically significantly different from those in the placebo group, but a ll values normalized in the post-treatment period. Cyclosporin can be a safe and very effective treatment in episodes of severe atopic derma titis, provided that the recommended guidelines for its administration are strictly observed.