Etanercept improved symptoms, quality of life for kids with moderate to severe disease,,,,
WEDNESDAY, Jan. 16 (HealthDay News) -- The drug etanercept significantly improved psoriasis symptoms in children under 17 with moderate to severe psoriasis, researchers are reporting.
The study found that 57 percent of the children and teens enrolled in the study had at least a 75 percent improvement in their symptoms, and their quality of life also improved.
"Psoriasis is not just some benign skin disease but can be truly life-altering for patients," said the study's lead author, Dr. Amy Paller, chairwoman of dermatology at Northwestern University's Feinberg School of Medicine.
"In our study, etanercept positively impacted quality of life," added Paller, who's also a pediatric dermatologist at Children's Memorial Hospital in Chicago.
Psoriasis is a common skin condition that causes the skin to grow at an accelerated rate. Because the skin cells are growing faster than they can be shed, scaly patches develop on the skin. The disorder tends to run in families, and doctors suspect it's an autoimmune disease, in which the body is mistakenly sensing that healthy cells are foreign substances. Nearly one-third of those with psoriasis also have what's known as psoriatic arthritis, according to the U.S. National Institutes of Health.
Mild cases of the disorder may respond to over-the-counter and prescription creams and ointments. But, for people with moderate to severe disease, stronger medications -- such as immune suppressants -- are often needed.
Newer medications, such as etanercept (Enbrel) and infliximab (Remicade), have been approved for treating psoriasis in adults. These medications, called biologics, specifically target the immune response, rather than dampen the entire immune system.
None of these medications has yet been approved for the treatment of children, however.
"This is the first trial that's been done in children and adolescents in this whole category of biologics for psoriasis," Paller said.
Etanercept is a tumor necrosis factor receptor (TNF). People with psoriasis have too much TNF, and entaercept reduces the amount of TNF. But, it can also lower the immune system's ability to fight infections.
To assess whether or not the drug was as safe and effective in children under 17 as it is in adults, Paller and her colleagues recruited 211 children and adolescents with moderate to severe psoriasis to participate in the trial.
Paller said the researchers chose etanercept, because it's already being used to treat children with juvenile rheumatoid arthritis and appears to be safe in that population.
The study volunteers, all between the ages of 4 and 17, were randomly assigned to receive 12 weeks of once-weekly injections of 0.8 milligrams (mg) of etanercept or a placebo. After the initial 12-week phase of the study, everyone was put on once-weekly etanercept for 24 weeks. Finally, at 36 weeks, 138 study volunteers were randomly chosen again to receive either etanercept or a placebo.
After 12 weeks, 57 percent of those on etanercept showed a 75 percent or greater improvement in their symptoms, compared with 11 percent on a placebo. During the 24 weeks when everyone received etanercept, 68 percent of those who had initially been on etanercept and 65 percent of those who started on a placebo showed a 75 percent or greater response.
During the second "randomized" portion of the trial, 42 percent of those placed on a placebo began having symptoms again.
Several children experienced infections while on etanercept, but all recovered without complications, according to the study.
"This is an incredible result," Paller said. "What's really exciting is we were worried because we were using a pretty low amount of etanercept. In adults who achieved the same blood levels of etanercept, there was a 30 to 34 percent response [of 75 percent or more]. Kids clearly are showing a better response than adults," she added.
The study was funded by Immunex, the manufacturer of Enbrel.
"This study was not a surprise. Etanercept has been approved for several years for psoriasis. It's very effective in adults and has a reasonably good safety record," said Dr. Mark Lebwohl, chairman of the medical advisory board of the National Psoriasis Foundation, and chairman of the department of dermatology at Mt. Sinai School of Medicine in New York City.
"Children with psoriasis grow up with a stigma; they get made fun of. Psoriasis has a profound psychological impact as well as a physical impact. Effective treatment really changes the lives of these kids in a very beneficial way," Lebwohl said.
To learn more about psoriasis, visit the U.S. National Library of Medicine.
SOURCES: Amy Paller, M.D., chairwoman of dermatology, Feinberg School of Medicine, Northwestern University, and pediatric dermatologist, Children's Memorial Hospital, Chicago; Mark Lebwohl, M.D., chairman of the medical advisory board, National Psoriasis Foundation, and chairman, department of dermatology, Mt. Sinai School of Medicine, New York City; Jan. 17, 2008, New England Journal of Medicine
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