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| |  Ustekinumab Effective in Broad Span of Psoriasis Patients: Presented at AAD By Jill Stein SAN FRANCISCO -- March 9, 2009 -- Ustekinumab is equally effective in psoriasis patients who have never been treated and psoriasis patients who have had previous therapy, researchers reported here at the American Academy of Dermatology (AAD) 67th Annual Meeting. Mark Lebwohl, MD, Dermatology Division, Mount Sinai School of Medicine, New York, New York, and associates analysed data on 1,996 patients with moderate to severe psoriasis who had previously used standard systemic therapies, biologics, or phototherapy and were enrolled in phase 3 trials. The results were presented on March 7. Patients were randomised to subcutaneous placebo or ustekinumab in 2 doses of 45 or 90 mg at weeks 0 and 4 then every 12 weeks. The placebo group was crossed over to receive either 45 or 90 mg at weeks 12 and 16 followed by dosing every 12 weeks. The primary efficacy measure was a 75% decrease in the Psoriasis Area and Severity Index score (PASI 75) at week 12. Baseline demographic and disease characteristics were generally similar across the 2 phase 3 trials and across treatment groups within each study. Across the 2 studies, most patients reported prior treatment with conventional systemic therapies and phototherapy; 43% had previously received at least 1 biologic. Results showed that the primary endpoint of PASI 75 at week 12 was achieved by 67.6% and 71.8% of patients who received ustekinumab, 45- and 90-mg groups respectively, compared with 4% of patients who received placebo (P < .001). PASI 75 response at week 12 was comparable in patients previously treated with conventional systemic therapies compared with patients who were naïve to conventional systemic therapies (70.4% vs 67.7%, P = .385). Patients who had received prior phototherapy and patients who had never received phototherapy had similar PASI 75 response rates. PASI 75 response rates were somewhat higher in ustekinumab-treated patients who were naïve to biologic therapy compared with patients who had received prior biologic therapies for their psoriasis. Ustekinumab was generally well tolerated. Funding for this study was provided by Centocor Research & Development, Inc. [Presentation title: Comparable Efficacy and Safety of Ustekinumab in Moderate to Severe Psoriasis Patients Previously Treated With Systemic Therapies and Treatment-Naïve Patients. Abstract P3322]
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