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New Drug Lets Kids Feel Good in Their Skin

Researchers at Northwestern University's Feinberg School of Medicine report the drug etanercept -- FDA approved for adults but never before tested in children for psoriasis -- was safe and dramatically reduced psoriasis flare-ups in pediatric patients.

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January 16, 2008 | by Marla Paul

Amy Paller, M.D., the Walter J. Hamlin Professor of Dermatology and chair of dermatology at the Feinberg School of Medicine, discusses the social impact of psoriasis on children.

CHICAGO –- Maria Anichini, a 20-year-old junior at Columbia College, zipped up a fetching black lace cocktail dress with spaghetti straps to go out with friends the other night. Nothing out of the ordinary for most young women, but for Anichini it was a remarkable moment. She didn't have to hide her arms under a shawl or camouflage her legs under nylons. Her skin was smooth and completely clear of the itchy and red scaly patches of psoriasis that used to cover nearly every inch of her body.

Anichini, who's had psoriasis since she was 6, has spent most of her young life hiding under long sleeves and pants so kids didn't stare or tease her.

"They'd say 'Eeww! What's the matter with your skin?' " she recalled. "I would pretend it didn't matter, but I felt weird. I couldn't be a normal kid."

But her skin -- and her life -- have rebounded since she became part of a national trial testing an injectable drug for children and adolescents with moderate to severe plaque psoriasis, one of the most common inflammatory skin diseases.

Researchers at Northwestern University's Feinberg School of Medicine report the drug etanercept -- FDA approved for adults but never before tested in children for psoriasis -- was safe and dramatically reduced psoriasis flare-ups in pediatric patients.

The study will be published Jan. 17 in the New England Journal of Medicine.

"These kids' lives have been changed by being in this study and then staying on the drug," said lead investigator Amy Paller, M.D., the Walter J. Hamlin Professor of Dermatology and chair of dermatology at the Feinberg School. Paller also is a professor of pediatrics at the Feinberg School.

About 7.5 million people in the United States have psoriasis, a disease in which the immune system causes skin cells to grow at an accelerated rate. One third of those cases begins in childhood, sometimes as young as infancy. The often itchy, painful and disfiguring red scales can cover the scalp, face, arms, legs, feet and even the genital area.

Many of the Chicago area trial participants were long-time patients of Paller, who is a physician at Children's Memorial Hospital. "They are doing better now than they've done with any other treatment," she said. A total of 211 pediatric psoriasis patients from 42 sites in the United States and Canada participated in the 48-week study.

The randomized, double-blind, controlled trial showed 57 percent of patients on etanercept for 12 weeks achieved a 75 percent or greater improvement in symptoms compared to 11 percent of patients who received a placebo. A 75 percent improvement is considered "the gold standard" in psoriasis care, Paller said.

Etanercept is a type of protein that blocks the action of a substance produced by the immune system called tumor necrosis factor (TNF). People with immune diseases such as plaque psoriasis have too much TNF in their bodies.

The new drug option is significant because existing treatments for children and adolescents are limited, inconvenient and carry risks. They also do not work effectively for all children.

Some treatments include greasy topical steroids or ultraviolet light therapy, which carries the risk of skin cancer. Another option is chemotherapy drugs, which suppress the immune system and can potentially damage the liver and the kidneys, or cause hypertension.

"From what we can see so far, etanercept is a much safer alternative," Paller said. She hopes the study results will spur the drug's approval by the FDA for pediatric use.

"Psoriasis can be extremely alienating for children," Paller noted. "I've had patients, especially during teenage years, who have been quite depressed by their disease. If they're being teased or excluded by other kids, or have to exclude themselves from sports because it's uncomfortable, that has profound implications on their ego development."

In fact, children with psoriasis have a higher risk of depression and obesity, Paller said. Although it is unclear whether there is a metabolic or psychological basis to the increased risk of obesity, Paller wonders if starting young psoriasis patients on etanercept will lower their risk for being overweight.

Anichini said her years of struggling with psoriasis might have affected her personality as she grew up. "I'm not that outgoing and maybe that's because of the psoriasis," she said. "I never wanted to put myself out there and be the center of attention. I'd stay in the shadows."

But that's changing for her. "The drug has made it a lot easier to be social and put myself out in the world," Anichini said. "I feel like a whole load has been lifted off my chest. I can dress like everyone else. I feel normal."

The trial was supported by Immunex, a wholly owned subsidiary of Amgen, and by Wyeth Pharmaceuticals. Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL, the trade name for etanercept in North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Paller is a paid consultant and investigator for Amgen.