Lawrence Eichenfield, MD

US Food and Drug Administration (FDA) approval

 of roflumilast (Zoryve) cream 0.05% for atopic dermatitis in patients aged 2 - 5 years, 

 interviewed Lawrence Eichenfield, MD, about his team’s data on the new non-steroidal option.

Roflumilast cream’s safety and efficacy as a long-term alternative to topical corticosteroids for children was highlighted in this recent interview by Eichenfield, the chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at UC San Diego’s School of Medicine. In this segment of his interview, he was asked about additional information on the drug.

Comparing Roflumilast Cream to Other Topicals for Atopic Dermatitis, With Lawrence Eichenfield, MD

“This is a classic vehicle control study of children 2 to 5 years of age, mild to moderate atopic dermatitis,” Eichenfield noted. “The application is once-a-day, for a 4-week time course, and with all the [roflumilast] product for atopic dermatitis, similarly in the older age group, they did a 4-week time course…And with the core outcomes, we looked at what percentage of patients get to clear or almost clear, and at least a 2-step improvement. So all the patients who started as mild, to count as [having] treatment success, have to make it totally clear.”

Eichenfield highlighted other elements of these data leading to the FDA approval of roflumilast cream. INTEGUMENT-PED trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study all showed positive results across all efficacy endpoints, with the drug being safe and well-tolerated among study participants.

Eichenfield was asked about the drug’s implementation among children with mild to moderate disease, highlighting its potential for use by caregivers.

“You're not going to, say, use 8 weeks of a steroid and keep using it,” Eichenfield said. “You have a different regimen, because you can't do it that way. I do think that you know they can use it, they can use it as-needed, but it wouldn't be an expectation that they necessarily need to use it every day as they come under control.”

For any additional information on roflumilast cream 0.05% and its use among children with atopic dermatitis, view the interview posted above.

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

Eichenfield previously reported grants and personal fees from Arcutis, as well as from Amgen, AbbVie, Dermavant, Galderma, Incyte, Eli Lilly, Pfizer, Regeneron, and Sanofi.

Brooks A. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. October 6, 2025. Accessed October 8, 2025. 

https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years

Arcutis Biotherapeutics. FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5. October 6, 2025. Accessed October 8, 2025. 

https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-005-treatment

Videos

In this interview, additional information on roflumilast (Zoryve) cream 0.05% for patients aged 2-5 years with atopic dermatitis was highlighted.


Roflumilast cream 0.05% (Zoryve), a non-steroidal topical designed for the treatment of mild to moderate atopic dermatitis in children ages 2 - 5 years, was 

approved by the US Food and Drug Administration (FDA)

The approval of roflumilast cream 0.05 % followed recent trial data confirming the drug’s safety and efficacy as a long-term alternative to topical corticosteroids for children. To discuss these data and the approval’s significance in atopic dermatitis, 

 spoke with Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at UC San Diego’s School of Medicine.

Significance of Roflumilast Approval for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

“I think that basically…in this age group, it's the families that come in with incredible concerns about topical corticosteroids, probably overblown concerns about them,” Eichenfield explained. “Then [they’re] coming up with regimens of care that they're comfortable with, when they're uncertain about the safety of some topical products. This can very much limit the ability for us to control the rationale of eczema. In this younger age group, there's a lot of dry skin barrier dysfunction, often pretty significant body surface area, even in many mild patients.”

This approval of roflumilast was based on results from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study.

Eichenfield highlighted that, following roflumilast cream’s approval, having a specific product developed for this age group that is an effective non-steroidal with strong tolerance is notable. He also highlighted the low levels of stinging and burning and the strong efficacy and safety record of roflumilast.

“The part of the gap that we face is what we can do to have patients and families use a medicine as liberally as needed for effective clearance,” Eichenfield said. “I mean, I really push for minimal rash, minimal itch, and minimal sleep disturbance, and especially in this 2 - 5 year old age group, there's a ton of sleep disturbance which impacts the whole family. So if I have a highly effective agent, it can be used in different parts of the body. You don't need multiple prescriptions for different areas.”

Eichenfield has previously reported grants and personal fees from Arcutis, as well as from Amgen, AbbVie, Dermavant, Galderma, Incyte, Eli Lilly, Pfizer, Regeneron, and Sanofi.

This interview follows the FDA’s recent approval of Arcutis's roflumilast (Zoryve) cream 0.05% for patients aged 2-5 years with atopic dermatitis.

A subgroup analysis of the ICONIC-LEAD study had its findings presented at the World Congress of Pediatric Dermatology Annual Meeting, demonstrating that adolescents living with 

 given once-daily treatment with icotrokinra (JNJ-2113) saw increased rates of clear or almost clear skin at 16 weeks versus placebo.

After these data were released by Johnson & Johnson, the 

 editorial team interviewed Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at the UC San Diego School of Medicine, who had been an investigator in this analysis. Here, Eichenfield highlights the study’s 

 and their significance for dermatologists.

Significance of Icotrokinra Findings for Adolescents with Psoriasis, with Lawrence Eichenfield, MD

“I think my big takeaway is that we have incredibly potent results in terms of this drug, with an incredibly good safety profile as well,” Eichenfield explained. “An easy number to walk away with is that there was almost 90% of patients made PASI 90 at 24 weeks, so we didn't even show PASI 75 data…It was 86.6% of patients at 24 weeks, it was 70.5% at the earlier time point of 16 weeks, and very low placebo response rate at 16 weeks.”

In the team’s other primary endpoint, which was an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) with a 2-grade improvement at least, 84.1% of subjects at the 16-week mark and 86.4% at the 24-week mark reported such a response.

“You have to mention the safety as well, and the data set is very consistent,” Eichenfield said. “The overall study population data set was as well, which [means there were] not a lot of remarkable adverse events. There happened to be 2 serious adverse events in the adolescent group, but neither of them was considered secondary to the drug. One patient temporarily stopped the drug and went right back on it. Another 1 had been hospitalized for an evaluation, but it was not related to the drug and never stop the drug. Otherwise, it was an unremarkable side effect profile.”

Eichenfield was asked about what these results should mean to dermatologists and health care professionals reviewing the data from his team’s analysis.

“The big picture is that this technology has set up essentially biologic-like efficacy in an oral agent,” Eichenfield explained. “Certainly for adolescent psoriasis with this particular drug, in this particular peptide, I think having the ability to get such rapid effectiveness with a great safety profile, without the need for injectables, and without concerns about blood work, it's really going to be incredibly well received by the dermatology community.”

View the full video posted above to find additional information on this segment of Eichenfield’s interview.

The quotes implemented in this summary were edited for the purposes of clarity. Eichenfield is a paid consultant for Johnson & Johnson.

Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill. Johnson & Johnson. April 10, 2025. Date accessed: April 11, 2025. 

https://www.prnewswire.com/news-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill-302425136.html

This segment of the latest interview with Lawrence Eichenfield, MD, features a discussion about the ICONIC-LEAD study.

 released by Johnson & Johnson from a subgroup analysis of the ICONIC-LEAD study were presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting and demonstrated that adolescents with moderate-to-severe 

 treated with once-daily icotrokinra (JNJ-2113) received higher rates of clear or almost clear skin at the 16-week mark versus placebo.

These new data resulted from the first-ever phase 3 registrational analysis of moderate-to-severe plaque psoriasis to assess a systemic medication in adolescents and adults simultaneously. To discuss icotrokinra, the 

 team spoke with Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics and vice-chair of the department of dermatology at UC San Diego School of Medicine.

Notable Attributes of Icotrokinra for Adolescents with Psoriasis, with Lawrence Eichenfield, MD

“This is an exciting drug because it's bringing a new technology into the space that had basically been inhabited by injectable biologics,” Eichenfield explained. “We know that in pediatric psoriasis or adolescent psoriasis, something that's common, almost a third of adults relate that they had onset of their psoriasis in adolescent years or earlier. And most of our highest level efficacy medications for psoriasis were injectables.”

Eichenfield highlighted that what he finds exciting about icotrokinra is that the medication is a oral peptide formulated to block interleukin (IL)-23 at the receptor level. IL-23 is a potent regulator of psoriasis, Eichenfiled noted, with a variety of downstream effects on IL-17A, IL-17F, and IL-23.

“This is an oral agent, an oral blockade that can block IL-23 effects,” Eichenfield said. “Previously, we've seen in the phase 2 trials and the combination phase 3 trials great efficacy and safety.”

Eichenfield also discussed the phase 3 ICONIC-LEAD’s design, highlighting that the randomized control trial was set up to evaluate icotrokinra’s efficacy and safety versus placebo among a total of 684 trial participants. He later highlighted various elements of the study and the recent findings on icotrokinra.

For additional information on this segment of Eichenfield’s interview, view the full interview posted above.

The quotes used in the above summary were edited for clarity.

Eichenfield reports being a paid consultant for Johnson & Johnson.

In this interview, Lawrence Eichenfield, MD, speaks on his team’s recent research on icotrokinra for patients with moderate-to-severe plaque psoriasis. 

Lawrence Eichenfield, MD

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