New Drug Might Be Advance Against Eczema
An experimental drug may one day be a cure for eczema, a new trial suggests.
The drug, rocatinlimab, is a monoclonal antibody that researchers found prevented the recurrence of the symptoms of the skin condition for up to 20 weeks after treatment was stopped.
"Patients ask us in the clinic all the time, 'Can I stop the medication, or can I start doing it much less often?' Right now we don't have those medications available," said lead researcher Dr. Emma Guttman, professor and system chair of dermatology and immunology at the Icahn School of Medicine at Mount Sinai in New York City.
"Of course, it's important in adults, but imagine, in the future, how important this is in children. This drug may cause disease modification because it works on memory T-cells," she explained.
The drug works by blocking OX40 -- an immune molecule that activates inflammatory cells that play a role in the development of eczema, also called atopic dermatitis. The drug also prevents memory T-cells from storing the key to eczema.
"Because it works on memory T-cell formation, the cells that remember that the patient has the disease, maybe these cells will not come back to cause the disease again," Guttman said.
Atopic dermatitis is a debilitating chronic inflammatory skin disease, which often develops at a very young age, causing the skin to become inflamed, red, itchy, painful and dry, Guttman said.
For this phase 2 trial, nearly 300 adult patients were randomly assigned to rocatinlimab or placebo. Over 18 weeks, injections of the drug were given every two or four weeks, depending on the dose. Patients who received rocatinlimab continued to improve after 16 weeks, and most patients remained free of eczema for at least 20 weeks after treatment, the researchers found.
Side effects from the drug included fever, chills, headache, canker sores and nausea, all of which were mild and short-lasting, Guttman said.
A phase 3 trial is getting underway now. That trial will have more patients, including teens, and will follow them for two years after treatment has stopped, she said.
It will take at least three to four years for the treatment to be generally available if the phase 3 results pan out, Guttman said.
"This may be a disease-modifying drug, and if that's the case, it will be wonderful for our patients," she said. "Because ultimately, I think we want something that is maybe like a cure -- this is what patients will want."
Despite the findings, the real efficacy of the drug remains to be seen, said Dr. George Han, a dermatologist at Northwell Health in Lake Success, N.Y.
"One benefit of an OX40 inhibitor is that there's this idea that there are long periods of remission and you can come off the medicine and it will actually have durable responses," said Han, who wasn't part of the study.
"We don't have anything like that for eczema. But we have more targeted medicines and effective medicines," he said. "So it's hard to find an area where this really fits into the treatment landscape."
Han said that rocatinlimab would have to be so effective that patients would put up with its side effects.
"The only thing that would be compelling would be to say, 'Hey, I can give you this medicine for six months and there's a good chance that your eczema will be gone,'" Han said. "I think people will be able to accept some higher level of risk or side effects if that is the promise."
The report was published online Dec. 9 in The Lancet journal.
For more on atopic dermatitis, see the American Academy of Dermatology.
SOURCES: Emma Guttman, MD, PhD, professor and chair, dermatology and immunology, Icahn School of Medicine at Mount Sinai, New York City; George Han, MD, PhD, dermatologist, Northwell Health, Lake Success, N.Y.; The Lancet, online, Dec. 9, 2022