Ustekinumab Superior to Etanercept for Plaque Psoriasis: Presented at EADV

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Title: Ustekinumab Superior to Etanercept for Plaque Psoriasis: Presented at EADV
URL: http://www.pslgroup.com/dg/22CC0A.htm
Doctor's Guide
September 18, 2008

By Jill Stein

PARIS -- September 18, 2008 -- Patients with moderate to severe psoriasis who receive 2 subcutaneous injections of ustekinumab at 45 or 90 mg 1 week apart fare better than patients treated with etanercept 50 mg twice weekly, according to results of a 12-week, phase 3 trial presented here at the 17th European Academy of Dermatology and Venereology (EADV) Congress.

Christopher Griffiths, MD, FRCP, University of Manchester, Manchester, United Kingdom, and colleagues compared the safety and efficacy of the tumour necrosis factor alpha antagonist etanercept and the human monoclonal antibody ustekinumab for the treatment of moderate to severe psoriasis.

The study findings were presented on September 18.

In the trial, 903 patients were randomised in a 3:5:5 ratio to receive subcutaneous injections of ustekinumab 45 or 90 mg at weeks 0 and 4 or etanercept 50 mg twice weekly for 12 weeks.

Patients in the study were aged 18 years or older. They had a diagnosis of plaque psoriasis for at least 6 months and were candidates for phototherapy or systemic therapy, and had failed to respond to, had a contraindication to, or were intolerant to cyclosporine A, methotrexate, or psoralen plus ultraviolet A treatment. Patients also were naïve to both study drugs.

The primary endpoint was the proportion of patients who achieved >= 75% improvement in clinical severity as assessed by Psoriasis Area-and-Severity Index (PASI) at week 12.

A greater proportion of patients in the ustekinumab 45- and 90-mg groups (67.5% and 73.8%, respectively) achieved a 75% or greater improvement compared with those who received etanercept (57%; P = .012 for ustekinumab 45 mg; P < .001 for ustekinumab 90 mg, each compared with etanercept).

Also, 65.1% of the lower-dose ustekinumab group and 70.6% of the higher-dose ustekinumab group achieved a physician's global assessment (PGA) of "cleared" or "minimal" versus 49% of etanercept-treated patients (P < .001, for each comparison versus etanercept).

An improvement of 90% or greater in clinical severity PASI score was documented in 36.4% and 44.7% of patients in the lower- and higher-dose ustekinumab groups, respectively, versus 23.1% of etanercept-treated patients (P < .001, for each comparison versus etanercept).

In addition, in patients in whom standard systemic psoriasis therapies were inappropriate, greater proportions of patients in the ustekinumab 45 mg and 90 mg groups achieved an improvement of 75% or greater on the PASI score compared with patients in the etanercept cohort.

Ustekinumab and etanercept were generally well tolerated. The rates of adverse events, serious adverse events, and infections were comparable in the treatment groups.

The investigators said that their study shows that ustekinumab, given in 2 doses of either 45 or 90 mg, conferred better responses than twice weekly etanercept on both PASI and PGA assessments.

Funding for the study was provided by Centocor.

[Presentation title: A Phase 3, Multicenter, Randomized Study Comparing Ustekinumab and Etanercept for the Treatment of Moderate to Severe Plaque Psoriasis. Abstract FP1336]

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