Psoriasis drug excels in phase III study.
"With any drug you want efficacy, safety, and convenience," said Dr. Kristian Reich of Georg-August-Universitat, Gottingen, Germany, one of the trial's principal investigators, during a Web-based news conference. "We have an efficacy that's in the championship league of antipsoriatic therapy. We have a safety that we haven't seen so far, and [with] injections every 3 months, we have a very convenient healinglike therapy."
Ustekinumab is a fully human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 and interleukin-23; formerly known as CNTO 1275, it was discovered by Centocor Inc.
The phase III multicenter study involved 1,230 patients with chronic plaque psoriasis who were randomized to one of the following: placebo, two 45-mg doses of ustekinumab every 4 weeks, or two 90-mg doses of ustekinumab every 4 weeks.
At week 12, 67% of patients treated with 45 mg of ustekinumab and 76% of patients treated with 90 mg achieved at least a 75% reduction in psoriasis as measured by the Psoriasis Area and Severity Index (PASI 75), compared with just 4% of the patients treated with placebo. Additionally, 42% of patients in the low-dose group and 51% of patients in the high-dose group achieved PASI 90, or nearly complete clearance of psoriasis, compared with just 1% of patients receiving placebo.
Patients receiving either dose of ustekinumab experienced significant improvements in several quality of life measures, compared with patients receiving placebo. "These patients ... were some of the happiest patients that I've ever had the pleasure of treating with an experimental medication," said Dr. Craig Leonardi of St. Louis University, and lead investigator of the study.
Side effects from ustekinumab were mild and were comparable with placebo.
There was one death due to congestive cardiomyopathy. It is unknown whether this was related to the drug, because it was found that the patient had been treated for heart problems that were not disclosed during study enrollment.
If the drug is approved by the FDA, Centocor Inc. will have exclusive marketing rights in the United States. Dr. Reich and Dr. Leonardi disclosed that they have received grants from Centocor on a per-patient basis for conducting the trial.
BY ROBERT FINN
San Francisco Bureau
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|Publication:||Internal Medicine News|
|Article Type:||Clinical report|
|Date:||Feb 15, 2008|
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