点击显示 收起
Jan. 16, 2008 -- The itchy, red, and silvery skin patches that are the hallmark of psoriasis were constant companions for Maria Anichini from the age of 6.
At times they covered almost every inch of her body, causing her to choose long sleeves and pants even in the broiling heat of summer so people wouldn't stare.
But that all changed when Anichini, now age 20, began taking the injectable biologic agent Enbrel several years ago after entering the first large study to examine the drug's effectiveness in children and teens with moderate to severe plaque psoriasis. The most common type of psoriasis is plaque psoriasis.
Anichini's lesions started to clear up almost immediately, and these days the Columbia College junior is mostly free of them.
"It really is amazing," she tells WebMD. "I have some flare-ups now and then, especially in the winter. But it is nothing like it was."
Her response to the drug was not unusual.
In the newly reported study in which she took part, 57% of children and teens treated with Enbrel showed a 75% or greater?improvement in skin lesions and other symptoms after 12 weeks of treatment, compared with just 11% of kids who got placebo treatments.
Three out of four Enbrel-treated patients showed less dramatic, but still significant, improvements in lesions, compared with one in four placebo-treated patients.
The study appears in the Jan. 17 issue of The New England Journal of Medicine.
"We were surprised at how good the responses were because we used pretty low doses [of Enbrel]," says Northwestern University dermatology and pediatrics professor Amy Paller, MD, who led the study, which was funded by Enbrel makers Amgen and Wyeth Pharmaceuticals.
Approved by the FDA in the spring of 2004 for the treatment of psoriasis in adults, Enbrel blocks a key chemical messenger in the immune system linked to inflammation known as tumor necrosis factor-alpha (TNF-alpha).
It is now believed that inflammation plays a major role in a host of immune system diseases, including psoriasis.
Enbrel has been approved for the treatment of juvenile rheumatoid arthritis, but it had not been studied in children with psoriasis until now, Paller tells WebMD.
The study included 211 children and teens from 42 sites in the U.S. and Canada treated during the first 12 weeks with either once-weekly injections of placebo or up to 50 milligrams of Enbrel, depending on body weight.
After the initial 12 weeks of treatment, all the patients were treated with Enbrel for the following 24 weeks; then patients were again randomly assigned to treatment with either Enbrel or placebo for an additional 12 weeks to examine the effect of withdrawal.
The researchers reported that 68% of patients initially treated with Enbrel and 65% of those initially treated with placebo showed 75% improvement in lesions and other symptoms at week 36 of the trial.
Withdrawal from the drug was associated with a significant return of psoriasis lesions in 42% of patients.
"Our responses were as good as those seen in studies in adults with about half the dosage," Paller says. "We really don't know why that is."