New drug for severe eczema is successful in trials
The New York Times
The disease is characterized by an itching, oozing rash that can cover almost all of the skin. The constant itch, to say nothing of the disfigurement, can be so unbearable that many patients consider suicide. There has never been a safe and effective treatment.
On Saturday, the results of two large clinical trials of a new drug offered hope to the estimated 1.6 million adult Americans with an uncontrolled moderate to severe form of the disease, atopic dermatitis, which is a type of eczema.
Most patients who got the active drug, dupilumab, instead of a placebo reported that the itching began to wane within two weeks and was gone in a few months, as their skin began to clear. Nearly 40 percent of participants getting the drug saw all or almost all of their rash disappear.
For some, relief was almost instantaneous.
“I knew immediately I was on the drug” and not the placebo, Daniela Velasco, an event planner in Playa del Carmen, Mexico, said. Within a couple of weeks, the ugly red rash that had covered 90 percent of her body was almost gone. Even better, she said, “for the first time I didn’t feel any itch at all.”
The drug blocks two specific molecules of the immune system that are overproduced in patients with this and some other allergic diseases. The only side effects were a slight increase in conjunctivitis, an inflammation of the outer membrane of the eye, and swelling at the injection site.
“This is a landmark study,” said Mark Boguniewicz, an atopic dermatitis expert at National Jewish Health and University of Colorado School of Medicine who was not involved with the study. “For us in atopic dermatitis we are entering a new era.”
The studies, lasting 16 weeks and involving nearly 1,400 people, were published in the New England Journal of Medicine.
George D. Yancopoulos, the president and chief scientific officer at Regeneron, which, in partnership with Sanofi, makes the drug, said he expects the Food and Drug Administration to rule on dupilumab by March 29, 2017. The drug’s brand name will be Dupixent. The agency has given the drug breakthrough status, which provides expedited development and review of drugs for serious or life-threatening diseases.
Dr. Yancopoulos declined to speculate on dupilumab’s price, saying only that it will be “consistent with the value of the drug.” It is a biologic, the most expensive type of drug, and is injected every two weeks.
Atopic dermatitis experts said they have longed for a safe and highly effective treatment. In desperation, some prescribed other drugs off-label, like powerful immunosuppressants or high doses of steroids, which are far from ideal because even if they helped, their side effects can be severe — kidney failure with immunosuppressants, bone loss and even psychotic breaks with high-dose steroids.
Patients are miserable, Dr. Boguniewicz said. “Our patients and families haven’t slept through the night not for days or weeks but for months or years.”
Many doctors provide no treatments other than perhaps creams and ointments that do not stop the itching or soothe the red and weeping rash, said Jonathan I. Silverberg of Northwestern University’s Feinberg School of Medicine and a principal investigator in one of the studies.
Many sufferers can relate to the plight of the defense lawyer played by John Turturro in the HBO series “The Night Of.” He suffers from atopic dermatitis that started on his legs and his feet and later spread to his neck and head. Like so many patients, he tries treatment after treatment — bleach baths, covering the rash in Crisco and wrapping it with plastic wrap, steroids, Chinese medicine. He scratches it with chopsticks and disgusts people near him. But alltonoavail. Such experiences explain the excitement over the new drug, although researchers say they would like to see longer term data.