Promising Phase 3 trial results show biologic therapy ustekinumab significantly improved...(ith this chronic immune-related disease ...),Health

Date:10/3/2007

ith this chronic, immune-related disease, said Craig Leonardi, MD, St. Louis University Medical School and lead investigator of the study. The efficacy and safety data for ustekinumab in the treatment of psoriasis are exciting for the dermatology community.

At week 12 of this Phase 3, multicenter, randomized, double-blind, placebo-controlled trial, 67 percent of patients treated with 45 mg ustekinumab (two 45 mg doses four weeks apart) and 76 percent of patients treated with 90 mg ustekinumab (two 90 mg doses four weeks apart), achieved PASI 75 compared with four percent of patients receiving placebo (P < 0.001 for each comparison versus placebo). Also at week 12, 42 percent of patients in the 45 mg ustekinumab dosing group and 51 percent of patients in the 90 mg ustekinumab dosing group achieved PASI 90, or nearly complete clearance of psoriasis, compared with one percent of patients receiving placebo (P < 0.001 for each comparison versus placebo). Similar response rates were observed in the placebo group 12 weeks after crossover to treatment with ustekinumab. After one additional dose at week 16, responses were maintained through week 28, which is consistent with the maintenance regimen of every 12-week dosing currently being evaluated in the Phase 3 program. Improvements in clinical measures were paralleled with improvements in quality of life measures.

These findings show that by targeting IL-12/23 with ustekinumab, we may be able to offer dermatologists and patients a new, promising biologic therapy with an infrequent dosing regimen for the treatment of psoriasis, said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. We are encouraged by the results from the Phase 3 program and look forward to collaborating with regulatory authorities around the world in an effort to bring ustekinumab to physicians and patients in need of new therapeutic options.

Additionally, data will be presente
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Contact: Michael Parks 215-325-4010 Centocor, Inc. Source:Eurekalert

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