Amy S. Paller, MD

 approval of ruxolitinib cream was announced for pediatric patients 2 years of age and older with 

, providing a new therapeutic option in the treatment armamentarium for those with the disease.

To address the significance of this decision by the FDA, the 

 editorial team spoke with Amy S. Paller, MD, chair of the department of dermatology, director of Skin Biology and Diseases Resource-Based Center, and a Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine. Paller was asked about her hopes for the approval’s impact on pediatric patients.

Reacting to FDA Approval of Ruxolitinib for Pediatric Atopic Dermatitis, with Amy Paller, MD

“We've been really fortunate to see 3 new topicals coming out within the last few years, including getting it down to 2 years of age,” Paller explained. “So I'm delighted to see ruxolitinib joining the recent availability of tapinarof down to 2 years of age, and soon to be roflumilast down to 2 years of age. We'll really have some choices now for our families, particularly in more sensitive areas where we may not want to be using a topical corticosteroid. I think the next question is going to be, when are we going to get more under the age of 2, where we have many very young children who have atopic dermatitis, including in sensitive areas.”

Paller highlighted that for such patients, there has yet to be an FDA approval for a drug outside of crisaborole, which she stated can result in stinging and burning among many such patients.

Paller later connected the approval to the conclusions of her team's 

 from the PEDISTAD registry, in which the burdens of atopic dermatitis were highlighted among children and their families.

 Paller noted that a high disease burden was seen among children younger than 12 years with inadequately controlled disease at baseline, adding that long-term disease control and newer, safer drugs are needed in this pediatric population.

“Altogether, about 41% of patients were on a systemic medication at the time of enrollment, when these data were collected, so many of them were already being treated,” Paller said. “...When you look at how that was distributed, what was somewhat surprising to me was the large proportion that were on systemic corticosteroids in their history of treatment for atopic dermatitis. That was about 20%, including 18% of those kids who are under 2 years of age, who had received systemic corticosteroids.”

Paller noted that dupilumab had previously been used in only 21% of those under 6 years of age at the time of enrollment, and only in 4% from 0 to 2 years of age.

“But it was primarily the corticosteroids that these kids were being treated with, and I think that's an important point to make,” Paller explained. “I hope that really changes with time.”

For additional information on the significance of the FDA’s approval of ruxolitinib cream for atopic dermatitis in pediatric patients, view Paller’s full video response posted above.

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

Incytye. Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis. September 18, 2025. Accessed September 18, 2025. 

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib

Paller A. Atopic Dermatitis Burden Among Families of Children Under 6 Years, with Amy S. Paller, MD. HCPLive. June 11, 2025. 

https://www.hcplive.com/view/atopic-dermatitis-burden-among-families-children-under-6-years-amy-s-paller-md

Videos

This interview with Amy Paller, MD, highlights the significance of the approval of ruxolitinib for the treatment of pediatric atopic dermatitis.

A study titled ‘Disease and family burden of moderate-to-severe atopic dermatitis in children aged <6 years: results from the PEDISTAD registry’ was presented at the 

Revolutionizing Atopic Dermatitis (RAD) 2025 Conference

To discuss the study’s findings, the HCPLive editorial team spoke with investigator Amy S. Paller, MD, chair of the department of dermatology, director of Skin Biology and Diseases Resource-Based Center, and Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine. Paller was first asked about the study and its design.

Atopic Dermatitis Burden Among Families of Children Under 6 Years, with Amy S. Paller, MD

“It's really important to understand what the burden of atopic dermatitis is, not just on the patients, but very importantly, also on the family,” Paller explained. “PEDISTAD is an ongoing, global, 10-year observational registry. It only enrolls patients less than 12 years of age, and particularly now, has been interested in those younger patients who are less than 6 years of age at enrollment. This is a study that's been going on now for several years. Of course, it will continue, but it is allowing us to look at many aspects, including not only how to compare treatments, but also what the burden is for the family.”

Paller was asked about some of the most notable findings from the ongoing study among children under the age of 6 years.

“Well, of course, in these patients, there is a range of of severity, but the EASI score itself is in a moderate range,” Paller said. “We're also looking at the fact that the dermatitis family index was quite high. If we look at the 0 to less than 2 years, if we look at the 2 to less than 4 years, if we look at the total patients who are in this, the majority of them actually had at least a moderate effect or a high effect on the family itself. [These data] really emphasize that it's not just the child, but also the family, that is very much impacted by this disease.”

Paller also noted her own questions she provides to family members when asking about the effects of atopic dermatitis on their children.

“One of my leading questions when I talk to parents is, are you sleeping much?” Paller explained. “Then it all comes out, of course, because with these younger children, we either have parents who are up and down all night trying to soothe, just sitting or lying in the bed of the child, or we have parents who are co-sleeping, and this happens all too often. It's not really good for the child and certainly not good for the parent.”

Paller highlighted the experiences reported by many parents who will lie in bed holding the hands of their children to prevent them from scratching and the resulting lack of sleep.

“One of the signs for me when these parents of young children come back is not just how the child is looking or how much itch you see but, more importantly, are you getting some sleep now?” Paller said.

To find out more about the PEDISTAD registry information, view Paller’s full video interview posted above. For any additional information on new atopic dermatitis data, view our 

The quotes used in this summary were edited for clarity.

In this RAD 2025 interview, Paller highlights her team’s findings on disease and family burden of topic dermatitis in children.

Amy S. Paller, MD

Articles