Ellis, Charles N., Fradin, Mark S., Messana, Joseph M., Brown, Marc D., Siegel, Michael T., Hartley, A. Howland, Rocher, Leslie L., Wheeler, Suzanne, Hamilton, Ted A., Parish, Thomas G., Ellis-Madu, Mary, Duell, Elizabeth, Annesley, Thomas M., Cooper, Kevin D., and Voorhees, John J.
Cyclosporine, an immunosuppressant drug often administered to organ transplant recipients, is also effective against some forms of psoriasis (a chronic skin disease involving plaques and scales). To learn more concerning the optimal dose of cyclosporine for treating this disorder, a 16-week controlled study of 85 patients was carried out. The patients had at least one fourth of their body surface covered by plaque-type psoriasis, or severe psoriasis that was disabling, and an unsatisfactory response to standard treatments for the disease (ultraviolet light or psoralen). Patients were randomly assigned to receive daily doses of 7.5 milligrams (15 patients), 5 milligrams (20 patients), or 3 milligrams (25 patients) of oral cyclosporine per kilogram of body weight. Twenty-five patients received an inactive drug (the control group). After the first eight weeks, patients who did not improve (including controls) were adjusted to the next higher dose (those at 7.5 mg/kg went up to 10 mg/kg). Three specific lesions on each patient were rated at regular intervals during the study for scaling, redness, plaque thickness, and overall severity. In addition, overall severity and extent of involvement of the body were rated. Kidney function (which is affected by cyclosporine in many people), blood pressure, white blood cell count, and other physiological variables were also evaluated. All patients who received cyclosporine improved more than patients who received the vehicle; for the three dose levels (from lowest to highest), the decrease in the psoriasis global scores was 39, 58, and 71 percent, respectively. The best effect was in the highest-dose group (80 percent clear or almost clear of lesions). Adjustments to higher doses were required for the largest proportion of patients in the lowest-dose group (65 percent). Four patients left the study because of side effects, and four required dose reduction. Effects on renal and neurologic function were noted. The results indicate that the best initial cyclosporine dose for treating plaque-type psoriasis is 5 milligrams per kilogram per day. Additional long-term studies are needed to evaluate the drug's safety and effectiveness. (Consumer Summary produced by Reliance Medical Information, Inc.)