CROSSOVER STUDY OF THALIDOMIDE VS PLACEBO IN JESSNERS LYMPHOCYTIC INFILTRATION OF THE SKIN

Background and Design: An effective therapy is still unavailable for J essner-Kanof lymphocytic infiltration of the skin. Thalidomide's effic acy was suggested in an open study. Twenty-eight patients were randoml y assigned to receive thalidomide (100 mg/d) or placebo over a period of 2 months and were then switched to the other treatment. Results: Af ter the first period, 11 of 13 patients treated with thalidomide were in complete remission (CR), and there were two failures. There was no CR in the patients who received placebo (chi(y)(2) = 17.5; P<.0001). A fter the second period, nine of 14 patients who had received thalidomi de were in CR. Eleven of the 13 patients who had received thalidomide during the first period were given placebo (two were unavailable for f ollow-up). Ten of them were in CR: four were still free of lesions at the end of the second period, and six experienced a relapse of their l esions after a mean duration of 26+/-10 (SD) days. A total of 25 patie nts participated in the two study periods; CR was observed in 19 (76%) after thalidomide therapy and in four (16%) after treatment with plac ebo (chi(y)(2) = 11.1; P<.001). Of 27 patients who received thalidomid e, 16 (59%) were in CR after 1 month and 20 (74%) were in CR after 2 m onths. Two patients treated with thalidomide experienced neurologic ch anges that were not consistent with typical thalidomide-induced neurop athy. Conclusions: A therapeutic regimen of thalidomide administered a t a dosage of 100 mg/d far 2 months is able to suppress the clinical s ymptoms of Jessner-Kanoflymphocytic infiltration of the skin. The long -term risk-benefit ratio has still to be evaluated.