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| |  Patients With Benefit From Ustekinumab Treatment Up to 3 Years: Presented at AAD By Micheal Casasnovas MIAMI BEACH, Fla -- March 10, 2010 -- Through 3 years of treatment with ustekinumab, adverse events rates among patients with moderate to severe psoriasis remained stable -- without evidence of cumulative toxicity, announced researchers here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). “These analyses support a favourable benefit/risk profile for ustekinumab with up to 3 years of treatment, a profile which will continue to be elucidated in 2 ongoing phase 3 studies,” said Kenneth Gordon, MD, Division of Dermatology, North Shore University Health Systems, Skokie, Illinois, during a poster presentation on March 9. Researchers pooled safety data across phase 2 and 3 psoriasis studies to assess the safety of ustekinumab in the overall psoriasis clinical development program. The 1.5-year safety analyses included 2,266 patients. Included in this data were 36 weeks of data from the C0379T04 placebo-controlled phase 2 trial, 76 weeks from the PHOENIX 1 phase 3 trial, and 52 weeks from the PHOENIX 2 phase 3 trial. The 3-year safety analyses included 3,117 patients. Included in this data were 36 weeks of data from the C0379T04 placebo-controlled phase 2 trial, 152 weeks from the PHOENIX 1 phase 3 trial, 100 weeks from the PHOENIX 2 phase 3 trial, and 64 weeks from the ACCEPT phase 3 trial comparing ustekinumab and etanercept safety and efficacy. Dr. Gordon and colleagues evaluated cumulative safety data during the placebo-controlled periods in both groups. Through the common 12-week controlled period of the trials, 50.4% of patients treated with placebo, 57.6% with ustekinumab 45 mg, and 51.6% with ustekinumab 90 mg, experienced no more than 1 infection, adverse, or serious adverse event. Respectively, 1.9%, 1.1%, and 1.4% resulted in an adverse event that led to discontinuation during the controlled period. During the 12- to 20-week controlled period, serious infection rates were 1.70 per 100 patient-years for placebo, 0.49 per 100 patient-years for ustekinumab 45 mg, and 1.97 per 100 patient-years for ustekinumab 90 mg. Using the Marketscan Database for the combined ustekinumab group, serious infection rates were consistent with the expected event rate being 1.51 per 100 patient-years and the observed event rate of 1.19 per 100 patient-years. Nonmelanoma skin cancer malignancy rates were comparable with expected rates in the general public using the SEER database. No cardiovascular events were found in the placebo group during the placebo-controlled period versus 5 in the combined ustekinumab groups, 1.23 per 100 patient-years. Major cardiovascular event rates were low and remained stable without evidence of a dose response with extended exposure in both 1.5- and 3-year groups. Using the Framingham database, researchers found myocardial infarction and stroke rates were consistent or lower than the rates expected in the general public. “Overall, rates of serious of infection, serious cardiovascular events, and malignancy adjusting for follow-up did not increase with time or duration of ustekinumab exposure for up to 3 years,” said Dr. Gordon. Funding for this study was provided by Centocor Ortho Biotech. [Presentation title: The Ustekinumab Safety Experience in Patients With Moderate to Severe Psoriasis: Results From Pooled Analyses of Phase II and Phase III Clinical Trial Data. Abstract P336]
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