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Page: << Prev | 1 | 2 | 3 | Next >> "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.
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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.
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