Amgen, a Thousand Oaks, Calif., biotechnology company and Wyeth Pharmaceuticals, a division of Wyeth revealed Wednesday positive results from its Phase III study of ENBREL to treat moderate to severe plaque psoriasis in children and adolescents.

The new drug is designed for treating children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had not responded well to topical therapy or who received systemic therapy or phototherapy.

ENBREL was used to treat psoriasis in adults, but the trial reported that it was safe and effective in children as well.

The study was made on 211 patients lasting a total of 48 weeks. The study initially randomized patients to placebo or etanercept at 0.8 mg/kg weekly by subcutaneous injection for 12 weeks. All participants then received open-label etanercept for an additional 24 weeks.

Among the young patients treated with the drug for 12 weeks, 57 percent showed that at least a 75 percent improvement in disease severity scored compared with only 11 percent of those receiving a placebo, Amy Paller, M.D., of Northwestern University and colleagues reported in the January 17 issue of the New England Journal of Medicine.

“This randomized, placebo-controlled trial demonstrated that etanercept was effective in children and adolescents with moderate-to-severe plaque psoriasis,” said the authors, who are members of the Etanercept Pediatric Psoriasis Study Group.

“These etanercept data are encouraging and reinforce the importance of continuing to investigate treatment options that may help this particularly vulnerable patient population manage their disease,” said Amy Paller, study investigator and Professor and Chair of Dermatology.

The patients encountered mild or moderate side effects. The most common were upper tract infections, headache, nasopharyngitis, injection-site reactions, streptococcal pharyngitis, cough, vomiting and skin papilloma. There were four serious events including three infections and one ovarian cyst, which required removal. However, all patients recovered without permanent problems.

The results of the study were greatly welcomed by pediatricians. “This is the article by all the giants in the field. It’s a very well done study,” said Douglas Kress, M.D., chief of pediatric dermatology at Children’s Hospital in Pittsburgh, who was not involved in the study.

Amgen has already filed a supplemental Biologics License Application with the FDA for the use of ENBREL to treat pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy. If approved, ENBREL is expected to be the first biologic, as well as the first systemic medication, indicated to treat this disease in pediatric patients.

Psoriasis is known to affect about 1.2 million people in Britain. The disease occurs when the immune system causes skin cells to grow at an accelerated rate. It causes itchy, painful and disfiguring red scales on the scalp, face, arms, legs, feet and genitals. One third of cases begin in childhood and young people with the disease are more likely to suffer obesity and depression.

The study was funded by Amgen’s Immunex subsidiary and by Wyeth Pharmacuticals.