Dr. Linda Stein Gold discusses new, key topical agents for the treatment of atopic dermatitis and psoriasis, including ruxolitinib, tapinarof, and roflumilast.
Linda Stein Gold, MD, Director of Dermatology Clinical Research, Henry Ford Health, Detroit, Mich.
“The good news is there’s a whole lot new in topical therapy. And remember that topical therapy is really our mainstay of treatment. We write more topical prescriptions than systemic therapies,” said Linda Stein Gold, MD, who presented “What’s New and Hot in Topical Therapy” at the Fall Clinical Dermatology Meeting 2022.
“To begin with, we have a drug that was recently FDA approved for the treatment of atopic dermatitis, and that’s ruxolitinib (Opzelura, InCyte).”
A JAK inhibitor, ruxolitinib inhibits both JAK1 and 2 and was studied in patients 12 and older, said Dr. Stein Gold.
“We studied patients with up to 20% body surface area. And we studied in two different concentrations [and] compared to just the vehicle itself. This is an elegant cream, and it showed to be highly efficacious as compared to vehicle as early as week 2.”
More than half of patients using ruxolitinib as monotherapy achieved clear to almost clear skin, said Dr. Stein Gold.
“It is a nonsteroidal agent, which means it can be used on all different body surface areas. So that’s good news because we can use one agent for lesions on the face, the sensitive areas, as well as the tougher areas on the trunk or extremities. In terms of tolerability, this drug was well tolerated and [has a] really good safety profile.”
JAK inhibitors, including ruxolitinib, have a Black Box warning, so they should not be used on more than 20% body surface area, said Dr. Stein Gold.
“But this drug really fills an important void and gives us another nonsteroidal option for those patients, including adolescents, with atopic dermatitis.”
New Psoriasis Topicals
Tapinarof (VTAMA Cream, 1%, Dermavant) and roflumilast (DALIRESP, AZ&Me) are two new FDA approved nonsteroidal topicals for plaque psoriasis, said Dr. Stein Gold.
Tapinarof is an aryl hydrocarbon receptor agonist that is available in a cream formulation, she said.
“It’s a small molecule that works inside the cell, and it’s been shown to do a number of different things. It down regulates Th17 cytokines, it decreases oxidative stress, and [it] improves the skin barrier. It decreases Th2 cytokines and although it’s FDA approved for plaque psoriasis, it’s currently in phase 3 clinical trials for atopic dermatitis.”
Used as a monotherapy once a day for 12 weeks in clinical trials, tapinarof was shown to be statistically significant compared to vehicle in controlling mild, moderate, and severe plaque psoriasis in adult patients, said Dr. Stein Gold.
“We saw up to about 40% of patients getting to clear or almost clear with an important 2-grade improvement… What’s also interesting is that in the long-term clinical trials, we structured these studies different than what we’d seen before. We actually allowed patients to remain on drug until they got completely clear of their psoriasis.”
According to Dr. Stein Gold, patients showed a 4-month remittive effect.
“…which means that if you get your patients to completely clear skin, on average they can go 4 months without having to go back on their medication. So that’s quite good news for a lot of our psoriasis patients.”
Adverse events included mild or moderate folliculitis or contact dermatitis, and did not deter most patients from continuing therapy, she said.
“The third new drug, which is also a nonsteroidal, is roflumilast, and this has also been FDA approved for the treatment of plaque psoriasis.”
Roflumilast is another once-a-day nonsteroidal PDE4 inhibitor, but it’s also 300 times more potent than other currently available PDE4 inhibitors, said Dr. Stein Gold.
“This drug was studied once a day, again, a cream formulation for plaque psoriasis in adults, and we found that about 42% of patients got to clear or almost clear with that 2-grade improvement after 8 weeks of therapy.”
Roflumilast was also shown in studies to be highly effective in the intertriginous areas “…which can be quite tricky to treat because we can’t use a potent steroid in the sensitive areas.”
According to Dr. Stein Gold, side effects included headaches and diarrehea, but treatment was generally well tolerated.
“A little bit of this drug might be systemically absorbed, but we understand that even taking PDE4s systemically, they’re generally well tolerated.”
All three topicals can be used on most body surface areas, said Dr. Stein Gold.
“I call these drugs ‘one-stop-shopping’ because we can use them on the face, the intertriginous areas, [and] the thick areas like the elbows and knees. “
According to Dr. Stein Gold, a user-friendly foam formulation of roflumilast may soon be available treating rosacea of the scalp, said Dr. Stein Gold.
“The bottom line is it’s a really exciting time for topical therapy. We have some wonderful new treatments for atopic dermatitis and psoriasis and we can get our patients under control even better than we have before.”
