New study reports on effectiveness of ENBREL in children
New study reports on effectiveness of ENBREL in children
Portland, Ore-(January 23, 2008) An article in the New England Journal of Medicine (Jan. 17, 2008, issue) reports positive results from a study that examined the effectiveness and safety of ENBREL to treat pediatric psoriasis. The study indicates that patients in the double-blind study who received ENBREL (etanercept) saw significant improvement (both the signs and symptoms) of their psoriasis.
This is very promising news for children with psoriasis and their families," said Pam Field, Acting President and CEO of the National Psoriasis Foundation. "This could be the first step toward an entirely new level of care for this vulnerable and underserved population."
The data resulted from a Phase 3 study conducted by the drug's maker, Amgen and Wyeth Pharmaceuticals. During the 48-week study, 106 randomized patients between 4 -17 years old were given ENBREL, 105 pediatric patients were randomized to receive the placebo. Efficacy was measured by the standard Psoriasis Area Severity Index (PASI) of patients achieving 75 percent or greater disease improvement from baseline (PASI 75). The primary efficacy endpoint was PASI 75 at week 12.
To be included in the study, the patients' disease had to have been inadequately controlled with topical treatments or they had to have received systemic therapy or phototherapy with inadequate results.
Currently, ENBREL is approved by the Food and Drug Administration (FDA) to treat moderate to severe psoriasis and psoriatic arthritis in patients 18 years and older. It is currently not indicated for treatment of pediatric psoriasis. Amgen is in the process of asking the FDA to approve the drug for use in children, and has filed a supplemental Biologics License Application (sBLA).
ENBREL is a type of protein called a tumor necrosis factor-alpha (TNF-a) blocker, a substance that the human immune system makes naturally. A normal immune system protects the body against "invaders" by destroying bacteria, viruses and other foreign proteins. In the person who has psoriasis, the immune system "misfires" and inappropriately causes inflammation and an accelerated growth of skin cells. The skin cells reproduce too quickly and the skin (and the joints in some people) becomes inflamed. TNF-a blockers reduce the activity of this specific protein with the result that most patients experience fewer symptoms of their disease.
For more information about psoriasis, please visit www.psoriasis.org.
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