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| |  Ustekinumab Reduces Symptoms of Psoriatic Arthritis, Diminishes Skin Lesions NEW YORK -- February 11, 2009 -- Ustekinumab reduces symptoms of psoriatic arthritis (PA) and diminishes skin lesions compared with placebo, according to a study published early online and appearing in an upcoming edition of The Lancet. Alice Gottlieb, MD, Department of Dermatology, Tufts Medical Center, Boston, Massachusetts, and colleagues conducted a randomised, controlled, phase 2 study of 146 patients with PA from 24 sites in Europe and North America. Patients with active PA were randomised to receive either ustekinumab (90 or 63 mg) every week for 4 weeks (weeks 0-3) followed by placebo at weeks 12 and 16 (n = 76; group 1); or placebo (weeks 0-3) and ustekinumab (63 mg) at weeks 12 and 16 (n = 70; group 2). The first 12 weeks of the study were placebo controlled. The primary endpoint was how many patients had seen a clinical response defined by 20% improvement from baseline in the American College of Rheumatology (ACR20) core set measures. At week 12, 3 times the proportion of patients in group 1 (42%) achieved ACR20 compared with group 2 (14%). Of 124 (85%) participants with psoriasis affecting 3% or more body surface area, 33 of 63 (52%) in group 1 and 3 of 55 (5%) in group 2 had a 75% or greater improvement in psoriasis area and severity index score at week 12. During the placebo-controlled period (weeks 0-12), adverse events arose in 46 (61%) patients in group 1 and 44 (63%) in group 2; serious adverse events were recorded in 3 (4%) group 2 patients and none in group 1. "Our findings show that ustekinumab is efficacious and safe for treatment of active psoriatic arthritis," the authors wrote. "Our study is one of the first to implicate the role of interleukin-12/23 P40 cytokines in the pathophysiology of this disorder. ... Larger and longer term studies are needed to further characterise ustekinumab efficacy and safety for treatment of psoriatic arthritis." In an accompanying comment, Racquel S. Cuchacovich, MD, and Luis R. Espinoza, MD, Section of Rheumatology, Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana, said, "The efficacy of ustekinumab for improving skin and joint involvement, which was maintained for several months, combined with good tolerability and a benign safety profile, make this agent an attractive option in psoriatic arthritis."
SOURCE: The Lancet
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