In patients with widespread psoriasis, treatment is difficult, and systemic medications often are required. The immunosuppressants methotrexate and cyclosporine can be used as treatments, but no head-to-head randomized trial has evaluated their relative efficacy. Heydendael and colleagues report on a comparative trial of the safety and efficacy of methotrexate versus cyclosporine for widespread psoriasis.
This study enrolled adult patients with moderate to severe psoriasis who had not responded well to treatment with ultraviolet B radiation and had not yet tried the study agents. Of the 111 patients initially screened, 88 were randomized. The most common causes for exclusion were liver abnormalities found on laboratory results or pretrial ultrasound screening. Trial participants were randomized to 15 mg of methotrexate once weekly given in three divided doses with a 12-hour interval between doses, or cyclosporine in a dosage of 3 mg per kg given in two daily doses. After four weeks, the study drug was increased in patients with less than a 25 percent reduction in psoriasis severity scoring. Methotrexate users were increased to 22.5 mg of the drug per week, while those assigned to cyclosporine were increased to a dosage of 5 mg per kg per day. Active treatment lasted for 16 weeks, followed by regular observation until one year after study entry.
Treatment had to be discontinued early in 12 patients taking methotrexate because of elevated liver enzyme levels, and in one patient taking cyclosporine because increased serum bilirubin levels and icterus were noted. Two patients developed hypertension while taking cyclosporine, but this condition was controlled with medication and slowly resolved after the treatment course was completed.
After 16 weeks of active treatment, the relative reduction in psoriasis severity scoring did not significantly differ between the group receiving methotrexate (64 percent improvement) and those taking cyclosporine (72 percent improvement). Complete remission of psoriasis was also similar between the two groups (40 percent of methotrexate patients and 33 percent of cyclosporine patients). The duration of remission after active treatment was short (an average of four weeks) and was similar in the two groups.
Minor side effects occurred in both groups, but they did not require dosage changes or discontinuation of the assigned treatment. Nausea was more common in methotrexate users (44 percent), while patients taking cyclosporine were more likely to have headaches (43 percent), muscle aches (29 percent), or paresthesias (33 percent). Quality-of-life scores were not significantly different in the two groups.
The authors conclude that methotrexate and cyclosporine have similar efficacy in the treatment of widespread psoriasis and are tolerated equally well.