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New Drug Bodes Relief for Youths' Arthritis Aches

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www.ProHealth.com • August 25, 2004


The drug trial's promise returned a teen to the U.S. By Ron Hayes, Palm Beach Post Staff Writer

On June 23, the United States government politely asked Helene Jensen to leave the country. Three weeks later, juvenile rheumatoid arthritis brought her back. The glitch in immigration law that sent the 17-year-old Dwyer High School student to stay with her grandmother in Denmark is a bureaucratic curiosity. Juvenile rheumatoid arthritis, which has earned her a year's reprieve while she participates in a medical trial, is almost as little-known.

"It's been hard," she said, settling back into her Palm Beach Gardens home a few days after her return from Denmark. "I can't run as much as I used to. ... Well, I can run, but if I do my knees would be killing me afterwards." She held a small vial containing Humira, the drug she and 170 other youths around the world have been testing. "I get the shots on Tuesdays," she explained, "and when it wears off, right before the next shot, I get a little achy."

To her family and friends, she is "Helene," or her nicknames, "Bird" and "Helooneytoons." To the scientists at Abbott Laboratories, which produces Humira, she is Subject No. 1709. Every other Tuesday, Helene injects herself with Humira, the brand name for adalimumab, a protein scientists produce in the stomachs of laboratory mice.

Adalimumab blocks the production of a substance called TNF-alpha, which is overproduced in the bodies of people with rheumatoid arthritis. The patent on Humira is shared in part by Dr. Richard Lerner, president of The Scripps Research Institute, where his earlier work led to its development. "It really is a miracle drug," Helene said. Maybe so. But not in Denmark, where she was born.

Helene came to Palm Beach Gardens in 1997, when she was 9 and her father, John, was given a work visa. A vice president of operations for Teeters Agency & Stevedoring at the Port of Palm Beach, John Jensen's visa expired in April. But while his older, American-born daughter, Charlotte, was able to sponsor her parents' applications to become permanent residents, immigration law does not let a sibling sponsor a sibling.

Helene flew to Denmark with two months worth of Humira while her parents sought a way to bring her back. An application for a student visa was rejected, but with help from U.S. Rep. Clay Shaw, R-Fort Lauderdale, and U.S. Ambassador to Denmark Stuart Bernstein, the U.S. Department of Homeland Security approved her return under a one-year "humanitarian parole" only because of the study and the fact that Humira is not available in Denmark.

When she flew back into Palm Beach International Airport on the night of July 21, Helene rejoined a very small community. "Juvenile rheumatoid arthritis is not that common," said Dr. Steven Goodman of Delray Beach, the pediatric rheumatologist treating Helene and 17 other children participating in the Humira study. "About 1 percent of adults get rheumatoid arthritis, but for children it's only about one in a thousand." About 60 percent of children ultimately outgrow their arthritis, Goodman notes, but there's no way of predicting which will be lucky. And because the disease is so rare, simply getting a diagnosis can be a challenge.

"On Sept. 30, 2002, I woke up and my left knee was totally swollen," Helene remembered. "I thought, it'll go away by the end of the day; but it didn't." Soon she couldn't walk up the stairs at school. She had X-rays, bone scans, MRIs, blood tests. She took Percocet, codeine, Oxycontin. By February 2003, when she came to Goodman, she was on crutches and had a brace on her left leg. "He knew right away when I told him," she said.

Jessica Larkin, 15, of Wellington, was a seventh-grader who played softball and flag football, ran cross country and loved to skateboard — until October 2002. "All of a sudden I started walking funny and I was stiff in the morning," she said. "You know how if you bend your fingers a hundred times it'll start to ache? That's what it feels like."

Her father, John, remembers the disease's emergence with a hint of embarrassment. "We thought she had flat feet," he said. "We bought different shoes. We said she had growing pains." His voice dropped. "We were kind of making fun of her. ..." By the time their family doctor recommended more exercise, the Larkins realized this was a bigger problem than laziness and returned to her pediatrician, who steered them to Goodman, who put her on Humira. Today, she can run the mile to Publix and back, and has taken up lacrosse. But there are limits. "I notice little things, " she said. "I can't close my fingers or sit cross-legged."

Triggers may surface illness Max Davis, chairman of the board of Arthritis Foundation for the mideast region of Florida remembered his reaction in 1992, when his 2 1/2-year-old granddaughter was diagnosed. "Children with arthritis, this can't be!" he said. "Even teachers in school don't believe children have arthritis."

Rheumatoid arthritis is an autoimmune disorder, but while doctors don't know the exact cause, they believe some people carry a genetic predisposition which is then triggered by factors such as infection, injury, hormonal changes and environmental causes. For example, Jessica Larkin has a twin sister, Jaime, and an older sister, Katie. Her twin has not developed rheumatoid arthritis, but Katie was diagnosed a month ago. She is not a part of the Humira study.

"In general, kids with arthritis don't have a tremendous amount of pain," Goodman said. "I saw a kid who had no symptoms at all and yet had terrible arthritis. But it can still lead to joint destruction, so it's important to get it under control. But stiffness is much more common in kids than severe pain."

Stephen Michaels, 15, of Parkland, was not that lucky. Diagnosed at 2, he was on crutches for a year and a half before undergoing "hip flexor" surgery in seventh grade to expand the motion of his joints. "Before the surgery, I could never lay on my stomach," he said. After the surgery, he used a wheelchair for another year, and then crutches and a walker again. Today, the effects of his ordeal are still clearly visible in his walk, but he plays snare drum and tom-tom in the Stoneman Douglas High School band, as well as Where Is Monday, a busy local rock group. In December, the group plans to host a fund-raiser for the Arthritis Foundation at Boynton Beach's Club Ovation.

When Stephen describes his medical history, you're reminded that arthritis is both a physical and a psychological ordeal. "Was I teased? Oh, all the time," he said. "Just basic bully stuff. If you're different, you're going to be secluded, but it never really bothered me." Search for a cure Moments later, he recalls telling schoolmates that he was on crutches because he had fallen off his bike and had broken his leg. "It seemed if I told people I fell off a bike it would be easier to accept me rather somebody who has a disability," he said, seemingly unaware that he has just said the teasing didn't bother him. "I just kind of hid everything and made up things."

Like Katie Larkin, Stephen is not part of the Humira study. Both use Enbrel, until the development of Humira, the most popular and effective biologic agent for treating arthritis. But unlike Humira, they must be injected twice a week as opposed to Humira's twice a month. "For me," said Jessica Larkin's father, John, "it's a miracle." John Whelton is a local rheumatologist who treats adults, for whom Humira has already been approved. "When it works, it is a miracle, it's like a light switch," said Whelton, who reports about a two-thirds positive response from Humira among his adult patients. "I had a patient tell me, 'It's the first time in 17 years I got out of bed without moaning.' "

Humira is not cheap. An adult dose costs about $1,500 a month, Goodman says. But because the dosage is adjusted for weight, a small child might use only a third the amount. He expects the Food & Drug Administration to approve Humira for use by children within a year, Goodman says. Until then, Abbott Laboratories has agreed to provide Helene, Jessica and the other children who participated in the study a free supply. "Rheumatology has advanced significantly in the treatment of rheumatic disease, particularly with these new biological agents," Goodman said. "But we have not yet found a cure, and we can't stop until we do."

Rheumatoid arthritis
• Almost 1 percent of the U.S. population, or about 2.1 million people, has rheumatoid arthritis. However, it is much rarer in children, appearing in only about one in a thousand.
• Among people with arthritis, women outnumber men 3-to-1.
• The cause of rheumatoid arthritis is unknown, but doctors believe it is mostly the result of a genetic predisposition triggered by other factors such as infection, injury, hormonal changes and environmental causes.
• For more information, contact the Arthritis Foundation of Florida Mid-East Region, 400 Hibiscus St., W. Palm Beach, (800) 654-1046. SOURCES: Dr. Steven Goodman, Arthritis Foundation of Florida. Source: www.PalmBeachPost.com



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