Ustekinumab reduces symptoms of psoriatic arthritis and skin lesions compared with placebo

February 11, 2009

The drug ustekinumab reduces symptoms of psoriatic arthritis (PA) and diminishes skin lesions compared with placebo. These are the conclusions of an Article published Online First and in an upcoming edition of The Lancet, written by Dr Alice Gottlieb, Department of Dermatology, Tufts Medical Center, Boston, MA, USA, and colleagues.

PA is a type of inflammatory arthritis that affects around 11% of patients with psoriasis, which is itself a chronic, non-contagious autoimmune disease which affects the skin and joints. Some patients do not respond to conventional drug treatments for PA, and thus alternatives are needed. Findings suggest that interleukins* 12 and 23 might affect clinical symptoms and pathological joint changes of psoriatic arthritis. Ustekinumab works by preventing interleukins 12 and 23 binding to cell membranes.

In this randomised, controlled, phase II study, the authors look at patients with PA from 24 sites in Europe and North America. Patients with active PA were randomised to receive either ustekinumab (90 mg or 63 mg) every week for 4 weeks (weeks 0𔃁) followed by placebo at weeks 12 and 16 (n=76; Group 1); or placebo (weeks 0𔃁) 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, three 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 three 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󈝸), adverse events arose in 46 (61%) patients in Group 1 and 44 (63%) in Group 2; serious adverse events were recorded in three (4%) Group 2 patients (none in Group 1). The authors conclude: "Our findings show that ustekinumab is efficacious and safe for treatment of active psoriatic arthritis. 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, Dr Racquel S Cuchacovich and Dr Luis R Espinoza, Section of Rheumatology, Department of Medicine, LSU Health Sciences Center, New Orleans, LA, USA, say: "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."
-end-
For Dr Alice Gottlieb, Department of Dermatology, Tufts Medical Center, Boston, MA, USA, please contact Julie Jette, Manager, Media Relations T) +1 617-636-3265 E) agottlieb@tuftsmedicalcenter.org / jjette@tuftsmedicalcenter.org

Dr Luis R Espinoza, Section of Rheumatology, Department of Medicine, LSU Health Sciences Center, New Orleans, LA, USA T) +1 504-896-1440 E) Lespin1@lsuhsc.edu

For full Article and Comment see: http://press.thelancet.com/ustekfinal.pdf

Notes to editors:

*Interleukins: Proteins produced by the immune system that mediate inflammatory reactions in diseases like psoriasis.

**ACR 20 criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: i) indicators of active inflammation ii) patient assessment iii) physician assessment iv) pain scale v) disability/functional questionnaire

Lancet

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