Amy S. Paller, MD

On March 16, Eli Lilly and Company released 

 from the phase 3 ADorable-1 study regarding lebrikizumab (Ebglyss) and its success in treating those with moderate to severe atopic dermatitis, including infants and children as young as 6 months.

These data suggest both of the ADorable-1 study’s co-primary endpoints were met while using this interleukin (IL)-13–targeting monoclonal antibody, currently 

-approved for moderate to severe atopic dermatitis in adults and adolescents.

 Lilly has also indicated its intention to submit the data to US and international regulators for a label expansion in younger pediatric patients.

Amy Paller, MD, chair of the department of dermatology at Northwestern University and an investigator in the study, spoke with 

 following the release of these findings. The following is a Q&A discussion with Paller about the biggest highlights:

What would you say stood out most among these findings from ADorable-1 as an investigator on this trial?

 The biggest takeaway is that we've been living with one advanced systemic only, for such a long time now, yet we have such a large part of our population, the pediatric population under 12, who have moderate to severe atopic dermatitis. They are just not responding well enough to topicals, or parents are putting on so much steroid that I'm sure that it's having some adverse effects over time. Not to mention the burden of disease and spending so much time.

The fact that we now have a second one that, hopefully, will move forward for FDA clearance is really thrilling to us as pediatric dermatologists. We've been waiting for this for a long time. We don't have any options other than what we've had for decades: methotrexate and cyclosporine. These are the options for kids who don't respond well to dupilumab or have an issue with it.

ADorable-1 enrolled patients as young as 6 months, a population where we have very few approved targeted options. How meaningful are these topline results to you as an investigator, and what does a 63% EASI-75 response rate tell us about the potential role of selective IL-13 inhibition in this age group?

 What it tells us is probably going to be on par with the type of changes that we've seen with dupilumab, and that's great. You know, we've all now had some experience with those who are 12 and above. We know that they're very different, these approaches, and we can't take a response to one and just apply it to the other. They're quite different, and again, it gives us an option. But it tells us that it's an option that looks to be pretty promising, and the majority, that is two-thirds of children within as short a period of 16 weeks, will have a tremendously meaningful improvement in their disease.

The trial used weight-based dosing alongside background topical corticosteroids. Can you walk us through the rationale for that design, and how confident are you that the efficacy signal here reflects lebrikizumab's contribution specifically, rather than the combination with topical therapy?

This has also been done with these other pediatric trials, including with dupilumab. It's just really not considered ethical in children to not provide some modicum of relief. Of course, these are children in whom the topicals weren't enough anyway, so putting them on a topical steroid on both arms is really an ethical move to try to assuage some of the pain, itch, and terrible aspects of this disease. That's where that comes from. The weight-based dosing, of course, reflects the fact that this is pediatrics.

We can't just give them adult doses, but it is tiered. So, the smallest children in the study would be getting something like the two loading doses, and then going to 125 every 4 weeks. Whereas the older children in the study would be, depending on where they were, if they were 40 kilograms and above, on the standard 250 milligram for 0, 2 weeks, and then every 2 weeks after that. If they were in the next tiered group, that is under 40, but I think it was over 15 milligrams, they would be getting the 250 after that, 2 weeks on an every-4-week basis.

Atopic dermatitis in infants and toddlers carries a significant burden not just for the patient but for the whole family. Beyond the clinical endpoints, what did you observe in terms of the real-world impact on patients and caregivers throughout the trial?

I don't know that that data is out there in the public domain yet, but I will just say, from my own experience, when you get something that works great, you get a lot of smiles on everybody's face. This is a disease that has a terrible burden, not just for the young children, but for the entire family. The parents don't sleep. When the kids don't sleep, the parents spend more time at the doctors and out of work. Kids are homesick, and it's a tremendous burden for, not just the parents but, of course, the entire family. Being able, in a relatively short period of time in this study, to turn around the burden of this disease really helps the physical and emotional burden for the entire family.

With Lilly planning regulatory submissions based on these data, what would a label expansion down to 6 months mean for how pediatric dermatologists approach treatment sequencing?

As I mentioned, it gives us options. I think we're very used to using dupilumab. I don't think that's going to go away, but I think that we now have an option for one or the other. There is going to potentially be a difference. We'll see what the FDA does. I really don't know, but the cutoff for going every 2-week-dosing with dupilumab was set at 30 milligrams. You get that 200-milligram every 2 weeks. Here, it's set at 40. So that means under 40, they'd be every 4 weeks based on the FDA. I don't know if that'll make a difference, but it gives a certain group of kids more of an on-label every 4 weeks.

For dupilumab, I often use it every 4 weeks for the kids in that group. That's 30 and above. This is just because that's the on-label for Europe, and it works just fine. The answer to your question is that we have options now for these kids of this age. We can have first-line dupilumab, we can have first line lebrikizumab. We certainly have options if they don't do well with whatever our first choice is.

What remaining questions would you most like answered in the next phase of research for lebrikizumab in this younger patient population?

I think it's always important to see a larger group beyond what's in the study. We want to see what the real-world experience is with first-line lebrikizumab, with changing from dupilumab to lebrikizumab. We certainly didn't see much in terms of any kind of adverse events during this trial, no new signals, and nothing of concern. But we'll keep an eye on whether there seems to be any difference with instance of ocular surface disease, although it's so low with dupilumab as well in this young population.

I think we're also going to be looking at the long term. One of the big questions: We talk now about the potential that dupilumab, which we know is on-label for asthma, and we know it is helpful for a variety of allergic and new mediated disorders. [The question is] whether there is going to be a role in reducing the development of other atopic diseases, in addition to reducing the severity of those diseases while on the drug; we just don't know how much of that is.

Specifically, the fact that the IL-4 receptor inhibitor of dopamine also inhibits IL-4 signaling directly…We may not get that with the IL-13-specific targeting. I think that will be an interesting question to look at further, looking at the development or the occurrence of these other allergic disorders with IL-13. That's going to be something. Then obviously, other questions that we have as well, are why vaccines? Is there any concern with giving a live vaccine? Theoretically, there would not be, but obviously that remains to be answered with real data. I think those are the 2 big questions that are out there.

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

Disclosures for Paller include the following: AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – investigator; AbbVie, Amgen, Asana, Dermavant, Dermira, Eli Lilly, Forte, Galderma, LEO Pharma, Matrisys Bioscience, Menlo Therapeutics, MorphoSys/Galapagos, Novartis, Pfizer, Regeneron Pharmaceuticals. Inc., Sanofi – consultant.

Campbell P. Phase 3 Trial Supports Lebrikizumab in Pediatric Atopic Dermatitis. HCPLive. March 16, 2026. Accessed March 17, 2026. 

https://www.hcplive.com/view/phase-3-trial-supports-lebrikizumab-in-pediatric-atopic-dermatitis

Eli Lilly and Company. Lilly’s EBGLYSS (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive Phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis | Eli Lilly and Company. Eli Lilly and Company. Published March 16, 2026. Accessed March 17, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-first-and-only-selective-il-13

Articles

Phase 3 ADorable-1 topline data support lebrikizumab, a selective IL‑13 monoclonal antibody, in moderate-to-severe atopic dermatitis for patients aged 6 months to 18 years, meeting both co-primary endpoints and achieving ~63% EASI‑75 at 16 weeks with background topical corticosteroids. Weight-tiered dosing aligned with pediatric pharmacology and mirrored ethical trial norms for symptom control. A potential label expansion would add a second advanced systemic option for younger children, enabling alternative first-line sequencing and switch strategies beyond dupilumab and legacy immunosuppressants.

Following the release of new results from the phase 3 ADorable-1 trial on lebrikizumab in pediatric patients, Amy Paller, MD, speaks in a new Q&A interview.

Significance of ADorable-1 Data on Lebrikizumab in Children with Atopic Dermatitis, With Amy 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.