New Eczema Drug Shows Promise in Early Trials
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Dupilumab, which is injected, interferes with the activity of two key proteins that play a critical role in the inflammatory processes that fuel eczema. A common skin disease, the intense itching and red lesions that are the hallmarks of eczema can become severe enough to lead to skin infections and sleep problems.
The drug hasn't been approved by the U.S. Food and Drug Administration yet, and the current research was preliminary.
However, the researchers report that early indications suggest that dupilumab is very effective at providing "marked and rapid improvement" for chronic eczema patients.
"There's this huge unmet need to treat moderate to severe eczema because at the moment we actually have no FDA-approved therapies," explained study author Lisa Beck, a professor in the department of dermatology and a professor of medicine in the division of allergy and immunology at the University of Rochester Medical Center, in Rochester, N.Y.
"We do have topical steroids and anti-inflammatory creams. But they tend to be only effective for mild disease, or just for treatment of the face," Beck added.
"We, on the other hand, are focused on patients facing a lifelong chronic situation, in which, on average, 40 to 50 percent of the patient's body surface is affected, cases of dramatic disease, for which topical therapies don't provide adequate relief," Beck said. "Based on the results from these early phase trials, this drug appears to be a medical breakthrough."
Beck and her colleagues report their findings in the July 10 issue of the New England Journal of Medicine. The study was funded by the drug manufacturers, Regeneron Pharmaceuticals and Sanofi Alliance.
Beck noted that eczema is extremely common, currently affecting up to 20 percent of children and up to 10 percent of adults. "It is far and away the most common inflammatory disorder of man," she said.
The authors also pointed out that roughly one-fifth of eczema patients suffer from a moderate-to-severe form of the disease.
Unlike topical therapies, the new drug specifically targets the inflammation-causing proteins known as interleukin-4 and interleukin-13.
Four successive studies -- collectively involving roughly 200 patients -- tested its effectiveness among people who had been living with moderate-to-severe eczema for about 25 years, on average.
The result: 85 percent of those treated with dupilumab experienced a 50 percent drop in overall disease severity. This compared with just 35 percent among those who were treated with a dummy injection (placebo).
More specifically, 40 percent of the dupilumab group saw a clearing (or almost clearing) of their skin lesions, compared with just 7 percent of the placebo group. What's more, itching dropped off among more than 55 percent of the drug group, compared with only about 15 percent of the non-drug group.
And among those in the final study who were treated with both the drug and topical creams, 100 percent of those who got both therapies saw a 50 percent drop in disease severity, the investigators found. This compared with just 50 percent of patients who got topical creams alone.
"I think this is a landmark finding because it's the first one that has found success with a drug that targets a specific pathway systemically, not topically," said Beck. "So it's very, very exciting."
Dr. David Pariser, a professor in the department of dermatology at Eastern Virginia Medical School in Norfolk, Va., agreed.
"There hasn't been anything new to treat dermatitis in years," he noted. "And there's certainly a therapeutic need. So, yes, this is both exciting and promising, even though I suspect that even in the best-case scenario it will be at least three years before this will be available for patients."
But Dr. Mark Davis, chair of the clinical division of dermatology at the Mayo Clinic in Rochester, Minn., added that "it's great to have any hope at all on the horizon."
Davis said, "This is really the first information we have on how well it works. So, we really don't know yet what place it'll find in our treatment arsenal. But it certainly would be great to have another quiver in our bow for treatment. Only time will tell."
SOURCES: Lisa Beck, M.D., professor, dermatology, department of dermatology, and professor, medicine, division of allergy and immunology, University of Rochester Medical Center, Rochester, N.Y.; David Pariser, M.D., professor, department of dermatology, Eastern Virginia Medical School, Norfolk, Va.; Mark Davis, M.D., professor, dermatology, and chair, clinical division of dermatology, Mayo Clinic, Rochester, Minn.; July 10, 2014, New England Journal of Medicine