Study suggests benefits of ustekinumab in treating psoriasis

Skokie, Ill. - Results of a recent study suggest that ustekinumab, a human monoclonal antibody, directed against interleukin 12 and 23 is an effective treatment for moderate to severe psoriasis, Reuters Health reports.

The study, done by researchers from Evanston Northwestern Healthcare in Skokie, appears in the May 17th issue of The Lancet.

The research team assessed the outcomes of 766 patients who were randomized to receive ustekinumab at one of two doses (45 or 90 mg) or placebo. Ustekinumab was given at weeks zero and four, and then every 12 weeks. Placebo was also given at weeks zero and four, but then patients crossed over to the active agent at week 12.

The study reports that patients initially treated with ustekinumab who achieved a long-term response  - a 75 percent or greater improvement in the psoriasis areas and severity index (PASI 75) at weeks 28 and 40 - were then re-randomized to either continue the drug or stop treatment until loss of response.

The PASI 75 rates at week 12 were 67.1 percent, 66.4 percent and 3.1 percent in the ustekinumab 45 mg, ustekinumab 90 mg and placebo groups, respectively. Long-term responses at 40 weeks were achieved by 150 and 172 patients in the lower- and higher-dose groups, respectively.

The PASI 75 response up to one year or longer was better maintained when ustekinumab therapy was continued rather than stopped at week 40.

Adverse events were seen in 54.5 percent of patients treated with ustekinumab and in 48.2 percent of those given placebo. The corresponding rates of serious events were 1.2 percent and 0.8 percent.

Reuters Health reports that in an editorial related to the study, Brenda L. Bartlett, M.D., and Stephen K. Tyring, M.D., both from the University of Texas Health Science Center, Houston, comment that “Although ustekinumab seems to provide a significant tool for the therapy of moderate to severe psoriasis, many questions remain,” such as the long-term safety of ustekinumab in terms of infections and malignancies and whether ustekinumab use will be beneficial in treating psoriatic arthritis.