A dose of 300 mg/day of
suplatast tosilate was administered to one hundred one cases of
atopic dermatitis for eight weeks, and the severity scores, peripheral blood eosinophil count, total serum
IgE levels, plasma
eosinophil cationic protein (ECP) levels, and other immunological parameters before and after the trial were observed and comparatively examined. The results are as follows: 1) Temporary improvements were found in the scores of severity and itchiness on all evaluated skin regions (face, limbs, and trunk). These scores decreased significantly for all observation periods at two, four, six and eight weeks after administration of
suplatast tosilate compared with those before the administration (p < 0.01). 2) There was no sign of adverse effects on the
drug. In the blood tests, one patient displayed elevated levels of GPT and another showed elevated total
bilirubin. In the urine test (qualitative test), one case with positive urinary
protein was observed. 3) Clinical examinations including assessment of the immunologic parameters were conducted at an average of 8.68 +/- 0.36th week. The peripheral blood eosinophil count, the percentage of eosinophil, and plasma ECP levels significantly diminished compared with those before administration, but no significant difference was found in total serum
IgE levels and LDH levels. 4) The subjects were divided into two groups, one in which the clinical scores were improved by more than five and another with scores of less than five (including worsening), and the fluctuation of the immunological parameters (values before and after administration of the
drug) of the two groups were compared. As a result, a significant difference was observed in the plasma ECP levels (p = 0.02) and peripheral blood eosinophil count (p = 0.091), but no difference was observed in total serum
IgE levels and LDH levels. From the above mentioned results, the high efficacy and safety of
suplatast tosilate in the treatment of severe
atopic dermatitis were confirmed. At the same time, a decrease in the peripheral blood eosinophil count and the serum ECP levels were observed, suggesting the possibility that these values could be used as indices of the severity of
atopic dermatitis.