By JoNel Aleccia
A disabling disease that can turn human hands into virtual claws may be eased or even cured by a new injectable drug, a study suggests.
The drug, called Xiaflex, could be an alternative to surgery for Dupuytren’s contracture, a benign but often crippling disorder in which collagen cords form in the hand, curling the fingers immovably into the palm, according to a report in today's New England Journal of Medicine. A Food and Drug Administration advisory committee has unanimously recommended approval of the drug for treatment of the condition. The FDA usually follows the advice of its advisory panels.
Dupuytren’s is named for Baron Guillaume Dupuytren, the 19th-century French surgeon who described the disease now believed to affect some 13.5 million to 27 million people in the United States and Europe.
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| New England Journal of Medicine |
| This patient's hand was involuntarily clenched like hook (left), until injections with an experimental drug. |
Ronald Reagan had the condition. Britain’s Margaret Thatcher has it, too. And J.M. Barrie, author of “Peter Pan,” may have used his own experience with Dupuytren’s as a model for the character of Captain Hook.
“It’s claw-like, if you will,” said Rod Van Sickle, 63, a retired Trabuco Canyon, Calif., firefighter who had to take a desk job after Dupuytren’s ravaged his hands. He had three surgeries on his right hand to correct the recurring condition before it shifted to his left. (A common pattern for the mysterious condition.)
Then Van Sickle joined a trial of 308 patients to receive injections of collagenase clostridium histolyticum, an enzyme that dissolves the thick cords that researchers say are stronger than steel.
“If I could show you my hands right now, my left hand is perfectly straight after three injections in three months’ time,” Van Sickle said.
Results of the trial, funded by Auxilium Pharmaceuticals of Malvern, Penn., the drug’s maker, report that the injections allowed nearly full or full extension in 64 percent of injected joints, compared to about 7 percent of joints injected with placebo.
Twenty-four hours after the injections, doctors manipulated the softened cords, which broke free with “an audible and palpable snap and a little burst of pain,” according to Dr. Roy A. Meals, the study’s chief investigator and a clinical professor of orthopedic surgery at the University of California, Los Angeles.
And that really hurts. Nearly 97 of patients in the trial reported pain, swelling, bruising or other problems.
The puzzling disease seems to be inherited and is related to hand trauma, smoking, alcohol and diabetes.
As it stands now, Meals said, only the people with the most severe cases, fingers bent to 30 degrees or more, are treated, and then usually with surgery, as was the case with Reagan and Thatcher. The others? “We advise those people to live with it,” Meals said.
Critics of the drug, which could cost as much as $1,500 per injection, say it will be as expensive as surgery and not necessarily covered by insurance.
In other pending trials, the drug is being tested for use to treat collagen build-up in other diseases, ranging from so-called “Frozen shoulder syndrome,” in which scar tissue limits shoulder motion, to Peyronie’s disease, in which plaques form along the penis, causing it to curve sharply to one side.
