Leon Kircik, MD

Three recently approved topical non-steroidal treatments for patients living with atopic dermatitis were highlighted by Leon H. Kircik, MD, medical director at Skin Sciences, PLLC, at the 

2025 Revolutionizing Atopic Dermatitis (RAD) Conference

 editorial team at RAD, Kircik highlighted these 3 additions to the 

 treatment armamentarium. He was first asked which drugs he highlighted in his conference talk.

Highlighting New FDA Approvals for Atopic Dermatitis, with Leon H. Kircik, MD

“As you know, the mainstream treatment is still topical steroids for atopic dermatitis,” Kircik said. “We all know that when you have a chronic disease, topical steroids are difficult to use continuously. Especially given that a big population of atopic dermatitis is pediatric or adolescent. We know the side effects, and we're learning more and more about topical steroid side effects, but one thing that we usually don't think about is the disruption of the epidermal barrier when it comes to atopic dermatitis.”

These patients, Kircik explained, already have a disrupted epidermal barrier. He expressed that topical steroids can inhibit lipid synthesis and, unfortunately, worsen epidermal barrier function.

“We're lucky now that we have recently 3 topical non-steroidals approved, including ruxolitinib…roflumilast, a PDE4 inhibitor, as well as tapinarof, an arylhydrocarbon modulator,” Kircik said. “So those 3 have recently become approved for atopic dermatitis, and I think they're going to become an important part of our treatment armamentarium in atopic dermatitis when avoiding topical steroid use.”

Kircik highlighted parental and patient concerns with regard to topical steroids, noting patients’ responses to the presence of non-steroidal options for atopic dermatitis.

“I think those non-steroidal topicals are being welcomed by patients and, more importantly, by parents of the kids with atopic dermatitis,” Kircik said. “Certainly, the efficacy is all there. When we look at the numbers, you see mostly the interruption of itch, so that's really important. Early onset of action [as well], and you see very good efficacy when it comes to IGA or EASI-75 scores. So I think overall, they have great efficacy and, most importantly, a safety profile.”

To learn more about Kircik’s interview, view the full video posted above. For more on subjects related to US Food and Drug Administration (FDA) approvals for atopic dermatitis, check out our 

The quotes used in this video summary were edited for clarity.

Videos

This interview highlights 3 new topical non-steroidal options for atopic dermatitis covered in Kircik’s RAD 2025 presentation on FDA approvals.

Over the course of his talk ‘Janus Kinase (JAK) Inhibitors in Atopic Dermatitis Management’ at the 

2025 Revolutionizing Atopic Dermatitis (RAD) Meeting

 in Nashville, Leon H. Kircik, MD, highlighted a variety of useful pieces of information related to the use of Janus-Kinase (JAK) inhibitors such as abrocitinib.

Kircik, who is known for his work as medical director at Skin Sciences, PLLC, in Louisville, Kentucky, was previously asked about the clinical advantages of JAK inhibitors in atopic dermatitis. In this interview segment with 

, he was asked about abrocitinib’s use among patients with the skin disease.

Abrocitinib Advantages Among Patients with Atopic Dermatitis, with Leon H. Kircik, MD

“I will be discussing abrocitinib, and I believe [Andrew F. Alexis, MD, MPH] is going to be discussing upacitinib,” Kircik said. “I was an investigator for abrocitinib in an atopic dermatitis study…It is approved for atopic dermatitis, and they are approved for 12 years of age and above we studied the drug both in 200 milligrams and 100 milligrams. Certainly, 200 milligrams is more effective than 100 milligrams. Across the world, except the United States, the approval said that you start with 100 milligrams and then, if you don't see efficacy, you can go up to 200 milligram after 12 weeks.”

Kircik expressed that he believed the most important label change happened recently regarding abrocitinib for atopic dermatitis.

“Now, they removed that 12 weeks [requirement] and you can actually go up to 200 milligrams the next day if the treating healthcare provider thinks it would be appropriate,” Kircik explained. “So I think that's a big advantage. Now we have much more flexibility with abrocitinib, and I think that's going to be a very important change in the label and give us more flexibility.”

Kircik was later asked why this shift could be viewed as helpful for patients and healthcare providers in terms of atopic dermatitis management.

“Abrocitinib works really fast, especially when it comes to itch,” Kircik said. “When I give a sample to the patient, they call me before they get to the car [saying] ‘What was this that you gave me? My itch is almost gone!’ Unfortunately, the reverse side of it is that, when you stop the treatment, just like any other JAK inhibitor, the half-life is so short with this drug that the symptoms do come back quite fast, unlike the biologics. So you can see that as the advantage or the disadvantage of the JAK inhibitors versus the biologics.”

To learn more about this information and related subjects on recent approvals for atopic dermatitis, view the 

The quotes used in this interview summary were edited for the purposes of clarity.

In this video segment, Kircik described the data highlighted in his JAK inhibitor-related presentation at RAD 2025.

 in Nashville, TN, about the contents of his talk ‘Janus Kinase (JAK) Inhibitors in Atopic Dermatitis Management.’

Kircik—known for his work as medical director at Skin Sciences, PLLC, in Louisville, Kentucky—was asked what he sees as the biggest clinical advantage of JAK inhibitors in atopic dermatitis. Specifically, he was asked about JAK inhibitors compared to traditional systemic therapies or biologics.

Addressing JAK Inhibitor Concerns in Atopic Dermatitis, with Leon H. Kircik, MD

“For JAK inhibitors, we certainly know their efficacy and the early onset of action,” Kircik said. “Oral JAKs work really fast. However, we know that there is a concern with boxed warnings. So when you compare to the biologics, of course, there is a concern with the safety of the JAK inhibitors versus the biologics.”

Kircik was asked more about the boxed warnings on JAK inhibitors. Specifically, he was asked abour counseling patients about the boxed warnings, especially in light of the broader JAK class warnings issued by the US Food and Drug Administration (FDA).

“I think as healthcare providers, first, we have to understand ourselves, the history of it, where it came from, and then accordingly, explain to the patient,” Kircik explained. “So as you know, the boxed warning comes from a drug called tofacitinib, and that drug was studied actually on rheumatoid arthritis patients. The boxed warning safety issues was raised because of the inferiority of the safety of tofacitinib in rheumatoid arthritis patients older than 50 years of age and at least with one cardiovascular event.”

Kircik added that, when looking at the patient population, there are not the same safety concerns, especially with topical JAK inhibitors such as ruxolitinib.

“I always tell patients, unless you're eating the cream, you have nothing to be concerned about,” he explained. “Absorption is very minimal, very low with topical ruxolitinib, and it's certainly not a concern. But according to the agency, it's a class effect, and we see that class effect everywhere. Ironically, when you look at oral ruxolitinib, which has been approved years ago for myelofibrosis, it doesn't have the boxed warning. So it's quite ironic that the oral ruxolitinib doesn't have a boxed warning versus the topical which does have one, but that's because of the class effect. Thus, everything after tofacitinib for inflammatory disorders got the boxed warning.”

For more of the late-breaking data and session coverage at RAD, view our 

The quotes used in this interview summary were edited for clarity.

This interview highlights the takeaways from Kircik’s talk at the 2025 RAD Conference regarding JAK inhibitor use and boxed warning concerns.

I think it’s very important when we consider a treatment option for a chronic inflammatory disease such as atopic dermatitis, psoriasis, or acne, etc…We deal with those a lot in dermatology, but in this case we are focusing on psoriasis to have long-term, not only safety, but also efficacy data. Because we do know that, unfortunately, sometimes patients that are very responsive originally to a drug, the first 6 months or a year, they lose their response to the same drug a year or 2 years later. Now, we really don’t know why that is. Is it because non-compliant patients stop using the drug? Is it because really the drug doesn’t work? But regardless, for one reason or another, it seems to happen. In conditions like this when we don’t have a cure, when people have to use a drug for long term, it’s important to know the long-term safety and efficacy.

And here, with topical roflumilast, I think we have that—not only we have that safety data that puts our minds at ease, unlike topical corticosteroids where we have a limited amount of time to use, we worry about the concerns, we worry that what if the patient is using it on their face, what if the patient is using it in their genital area, what if the patient didn’t tell me about genital psoriasis? It’s ironic. I do want to address genital psoriasis and intertriginous psoriasis since it’s relevant here when it comes to roflumilast, since they do have that in the label. Most of the time, genital psoriasis is quite underdiagnosed and we miss it because patients don’t tell, there is stigma attached to it, they think it might be a venereal disease that they don’t want to discuss with us. But it’s actually psoriasis, and then they use the steroid, and they use it in their genital area, and we don’t even know, sometimes. There were actually some very interesting surveys that showed that 42% of the patients used the steroids in the genital area without letting the doctor know. So, again, the safety of the topical here, roflumilast, becomes very important since there is no limitation or safety concern on the face, the genital area, or other intertriginous area.

A nonsteroidal topical such as roflumilast is going to be very welcome in our new armamentarium for psoriasis treatment. First of all, there’s a big unmet need for topical treatments for psoriasis in the nonsteroidal area. It can be a first-line but it can also be used in combination in our practice with systemic medications, or with other topicals. Sometimes we do need the topical steroids, you need to put that flare out as fast as you can. So, why not use a topical steroid in addition to a topical nonsteroidal? And then we can keep that patient on the topical nonsteroidal. But now, we do have really quite impressive efficacy with roflumilast that there may not be a reason to start the patient with a topical steroid. We may directly go to that topical nonsteroidal that we now have available. But I think the fact that the drug also has intertriginous efficacy history and data, and that is in the label, it makes it quite advantageous for us to start it with topical roflumilast.

In dermatology we do a lot of combination treatments. I say that the drugs are studied as monotherapy to get the drug approved. That’s how the drugs get approved, but when it comes in our hands in clinical treatment, we do use a lot of combinations. I don’t see why not to use it for a patient. For example, if you are using some systemic treatments or biologic, but they have a couple of resistant plaques, why not use an effective topical here such as roflumilast? So, I think the drug can be used as monotherapy, as first-line treatment, but also as a maintenance treatment, as well as a combination treatment with other systemics, or even with other topicals.

Leon Kircik, MD, shares his impressions of the long-term data of roflumilast, and where it fits into clinical practice.

Leon Kircik, MD

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