By Amy Norton
THURSDAY, July 16, 2020
A cream medication that eases skin inflammation might offer a safer treatment option for people with psoriasis, a new clinical trial suggests.
Psoriasis is a chronic skin condition that affects more than 8 million Americans, according to the National Psoriasis Foundation. The disease arises from an abnormal immune response that triggers rapid turnover of skin cells, causing them to pile up on the skin’s surface.
Most people have a form called plaque psoriasis, where they periodically develop red, scaly patches on the skin that can be itchy and painful.
The new study tested an experimental cream medication that may bypass the side effects of current topical treatments for psoriasis.
The cream contains a drug called roflumilast, which blocks an inflammation-producing enzyme. The researchers found that among patients randomly assigned to use the cream once a day, roughly one-quarter saw their skin clear up within six weeks. That compared with 8% of those given an inactive (“placebo”) cream.
Experts called the results “exciting” — in large part because the treatment is not expected to cause the side effects that can come with topical corticosteroids, the most common skin treatment for psoriasis.
High-potency steroids can be effective for the condition. But the downsides include thinning of the skin, changes in pigmentation and irreversible stretch marks, said Dr. Mark Lebwohl, the lead researcher on the trial.
That limits the drugs’ use, he explained, especially on sensitive areas like the face.
Other options, like vitamin D analogues, don’t work all that well and can irritate the skin, said Lebwohl, chair of dermatology at Mount Sinai’s Icahn School of Medicine in New York City.
Meanwhile, there are systemic treatments for psoriasis, including various injection and oral drugs. But they are usually reserved for more severe cases.
“The market has become crowded with systemic therapies,” Lebwohl said. “But most people have more moderate disease.”
Among the oral medications is apremilast (Otezla), a pill that targets an inflammation-producing enzyme called PDE-4. Roflumilast, the new cream-based medication, is also a PDE-4 inhibitor.
And, Lebwohl said, it could offer patients an equally effective nonsteroid alternative — if it is approved by the U.S. Food and Drug Administration.
Dr. Lawrence Eichenfield, a dermatologist who was not involved in the study, agreed that a new topical option would be “welcome.”
“It would be exciting to see an effective topical treatment for psoriasis that’s also well-tolerated,” said Eichenfield. He’s a professor of dermatology at the University of California, San Diego, and member of the American Academy of Dermatology.
The study results were published July 15 in the New England Journal of Medicine.
The trial included 331 adults with plaque psoriasis, usually a moderate form. On average, the condition affected 6% of their skin surface.
Patients were randomly assigned to one of three groups: Two used the roflumilast cream once a day, at either a lower or higher dose. The third used a placebo cream.
Within six weeks, 28% of patients on the higher dose had clear or almost-clear skin, as did 23% of those on the lower dose. That compared with 8% of placebo users, according to the report.
By week 12, those rates were up to 38% and 32% in the two medication groups, and 16% in the placebo group. There were no signs the medication caused skin irritation, Lebwohl said.
However, the study was only short term. Lebwohl said a larger trial is under way, and it will test the cream over a longer period.
If that trial goes well and the drug is approved, a real-world hurdle could arise: cost.
Topical corticosteroids are fairly cheap, and the new alternative would presumably be much pricier. “Ultimately, access will be an issue,” Lebwohl said.
Eichenfield said he doubted topical corticosteroids would be abandoned — not only because of cost, but because they have a long history of use.
For people with psoriasis, Eichenfield said, it’s important to be aware there are newer treatment options — pills and, possibly, a topical medication on the horizon.
The trial was funded by Arcutis Biotherapeutics, which is developing the drug. Lebwohl has received consulting fees from the company.
Copyright © 2020 HealthDay. All rights reserved.
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SOURCES: Mark Lebwohl, MD, professor and chair, dermatology, Icahn School of Medicine at Mount Sinai, New York City; Lawrence Eichenfield, MD, professor, dermatology and pediatrics, University of California, San Diego School of Medicine and Rady Children’s Hospital, San Diego; New England Journal of Medicine.
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