Lawrence Eichenfield, MD

Lebrikizumab led to significant itch reduction, with over 41% of patients achieving a 4-point Worst Itch Scale improvement.

More than 60% of lebrikizumab-treated patients saw clinically meaningful quality-of-life improvements.

Skin infections were less common with lebrikizumab than placebo, with no discontinuations due to adverse events.

In newly-released phase 3 findings, lebrikizumab therapy produced meaningful improvements in itch, quality of life, and overall disease burden among children and adolescents with 

These efficacy and safety findings were released from the ADorable-1 trial and presented at the Society of Pediatric Dermatology conference. Lawrence Eichenfield, MD, of the University of California San Diego and Rady Children's Hospital, served as an investigator on the study.

 interview, Eichenfield reported that itch outcomes varied by age group, with younger children assessed via the Worst Scratch/Itch Scale and older children evaluated using a 4-point improvement threshold.

What the ADorable-1 Trial Means for Pediatric Atopic Dermatitis Eczema Care

What the ADorable-1 Trial Means for Pediatric Eczema Care

How Much Did Lebrikizumab Improve Itch and Quality of Life?

Approximately 35% of lebrikizumab-treated patients achieved a 4-point drop in itch severity compared with 5% of those on placebo. The separation was even more pronounced on the Worst Itch Scale, where 41.6% of patients receiving lebrikizumab achieved a 4-point improvement, compared with no placebo-treated patients.

Quality-of-life measures also favored the active treatment arm. Eichenfield noted that a 6-point reduction from baseline is generally considered clinically meaningful; 61.6% of lebrikizumab-treated patients met that threshold, compared with 36% of the placebo group.

Is Lebrikizumab Safe for Children With Atopic Dermatitis?

Eichenfield described overall adverse event rates as not markedly different between arms, with no deaths and few serious adverse events reported. No patients discontinued treatment due to adverse effects, he noted. Skin infections occurred less frequently with lebrikizumab plus topical corticosteroids (2.4%) than with placebo plus topical corticosteroids (8.5%).

This was a finding Eichenfield attributed to the anti-inflammatory effect of IL-13 blockade on the skin microbiome. Conjunctivitis rates were described as 7.3% with lebrikizumab and 5.1% with placebo, and no cases of keratitis were observed.

What Unmet Needs Remain in Pediatric Atopic Dermatitis?

Looking ahead, Eichenfield emphasized unmet needs in young patients with moderate-to-severe atopic dermatitis, including questions about optimal biologic selection, treatment duration, and whether early intervention can modify long-term disease course.

He expressed particular interest in whether IL-13 blockade might also reduce the development of atopic comorbidities over time, an area he said warrants further long-term investigation.

Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

Eichenfield LF, Ornelas J, Prajapati VH, et al. Lebrikizumab for pediatric patients aged ≥6 months with moderate-to-severe atopic dermatitis: Phase 3 ADorable-1 Week 16 results. Poster presented at: Society for Pediatric Dermatology Annual Meeting; July 22-25, 2026; Minneapolis, MN.

Paller A. Significance of ADorable-1 Data on Lebrikizumab in Children with Atopic Dermatitis, With Amy Paller, MD. HCPLive. March 17, 2026. Accessed July 30, 2026. 

https://www.hcplive.com/view/significance-adorable-1-data-lebrikizumab-children-atopic-dermatitis-with-amy-paller-md

Videos

Lebrikizumab improved itch, quality of life, and infection rates in kids with moderate-to-severe atopic dermatitis, ADorable-1 results suggest.

ADorable-1 met key efficacy endpoints in pediatric moderate-to-severe atopic dermatitis.

Lebrikizumab demonstrated higher skin clearance rates than placebo plus topical corticosteroids.

The findings expand evidence supporting IL-13 inhibition in children with atopic dermatitis.

The growing armamentarium of treatments for 

 continues to generate new data available for clinicians managing moderate-to-severe cases of this 

 at the Society for Pediatric Dermatology (SPD) Annual Meeting, Lawrence Eichenfield, MD, discussed findings from the phase 3 ADorable-1 trial evaluating lebrikizumab in patients aged 6 months to younger than 18 years.

 He highlighted both the study's design and the efficacy outcomes, emphasizing the potential role of the therapy in younger patient populations.

ADorable-1 phase 3 study results: Key findings in pediatric atopic dermatitis for children with eczema

ADorable-1 Results: Key Findings in Pediatric Atopic Dermatitis

“Their initial approval was 12 years of age and older and [for] context, we know right now the only approved systemic biologic agent for atopic dermatitis under 12 is to is dupilumab,” Eichenfield explained.

New Phase 3 Data Highlight Pediatric Efficacy of Lebrikizumab

Eichenfield noted that the pediatric study builds on previous work evaluating lebrikizumab in adolescents, where the therapy was initially approved for patients aged 12 years and older. The ADorable-1 trial expanded the evaluation to include infants, children, and adolescents, enrolling patients from 6 months through 17 years of age.

Participants were divided into age-based cohorts, with one including children aged 6 months to younger than 2 years and another spanning older pediatric patients through adolescence.

According to Eichenfield, ADorable-1 was conducted as a randomized, placebo-controlled trial in which all participants received background topical corticosteroid therapy. He described this design as reflecting ethical considerations in pediatric research, ensuring that children in the placebo group still received active topical medications rather than remaining untreated.

Following a two-week run-in period with topical corticosteroids, participants were randomized to receive weight-based lebrikizumab plus topical corticosteroids or placebo plus topical corticosteroids for 16 weeks. Patients who achieved clear skin were permitted to taper topical corticosteroid use and transition to moisturizers alone.

Eichenfield emphasized that the trial enrolled a population with substantial atopic dermatitis burden. Approximately one-quarter of participants had severe disease at baseline, while the remainder met criteria for moderate disease.

Patients also presented with a mean Eczema Area and Severity Index (EASI) score of approximately 28 and nearly half of their body surface area affected, underscoring the severity of disease within the study population.

Lebrikizumab Results in Atopic Dermatitis at Week 16

By the 16-week mark, the study demonstrated clinically meaningful improvements across multiple efficacy endpoints. Among patients receiving lebrikizumab, 43.5% attained clear or almost clear skin compared with 15.0% of those receiving placebo plus topical corticosteroids. Similarly, 62.6% achieved EASI-75 versus 21.6% in the placebo arm of the trial.

Eichenfield also highlighted higher-threshold responses, including EASI-90 in 38.6% of treated patients and complete skin clearance (EASI-100) in 13.7%, describing the separation between treatment groups as encouraging for clinicians caring for pediatric patients with moderate-to-severe atopic dermatitis.

New phase 3 ADorable-1 data show lebrikizumab improved skin clearance in children with moderate-to-severe atopic dermatitis.

Tolerability of Roflumilast Cream 0.05% in Infants with Eczema, With Lawrence Eichenfield, MD

Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, spoke in another segment of his 

 interview on recent long-term safety and tolerability data drawn from the INTEGUMENT-OLE study, reflecting on what roflumilast cream .05% (Zoryve) could be for toddlers and preschoolers with 

These findings were poster data presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

. Building on the efficacy findings established in the INTEGUMENT-PED pivotal trial and the phase 2 INTEGUMENT-INFANT data presented at this year's meeting, Eichenfield turned in the second part of his conversation with 

 to address these new data from INTEGUMENT-OLE.

Eichenfield was careful to distinguish between 2 related but separate concepts. Tolerability, as he framed it, is the day-to-day experience of using this topical agent, whether it burns, stings, or leads to application site reactions resulting in cessation.

Safety is the broader question of whether accumulated use over time produces immunosuppression or other systemic impacts. On both of these subjects, Eichenfield said, the INTEGUMENT-OLE open-label extension study provided reassuring answers. More than 97% of participants showed no evidence of local irritation at any assessment point across the 56-week study period.

“They also asked the caretakers about reports of stinging or burning at each visit, and it was less than 1.8% of participants at any time point who, over that 56 week time period, had problems with tolerability,” Eichenfield said.

On the safety side, treatment-emergent adverse events (AEs) taking place at rates of 4% or higher were consistent with what clinicians expect in any cohort of 2- to 5-year-olds followed over a full year. Specifically, there were upper respiratory infections at a rate of 8.7%, some nasopharyngitis, some fever, and a small number of gastrointestinal events.

Serious adverse events (AEs) were observed in 3.2% of participants, none of which were considered related to treatment. Overall, treatment-related AEs were minimal. When asked how roflumilast cream fits within the overall management landscape for this age cohort, Eichenfield acknowledged concerns over topical corticosteroids among caregivers may be higher than ever, whether or not this view is always warranted.

This creates a practical need for a non-steroidal option for families to use with confidence, Eichenfield added. He also pointed to the INTEGUMENT-INFANT data as the next frontier for this research into roflumilast, describing the evidence base as now extending to children under 2, a group where the unmet need is even more acute and where the availability of a safe, effective non-steroidal option would be especially impactful.

Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting. Arcutis. March 28, 2026. 

https://www.globenewswire.com/de/news-release/2026/03/28/3264182/0/en/Arcutis-Presents-New-Phase-2-Results-in-Infants-with-Atopic-Dermatitis-in-Late-Breaking-Session-Today-at-the-2026-American-Academy-of-Dermatology-Annual-Meeting.html

Eichenfield L. New Data Support Roflumilast Cream in Infants with Eczema Over 4 Weeks, With Lawrence Eichenfield, MD. HCPLive. March 29, 2026. Accessed March 28, 2026. 

https://www.hcplive.com/view/new-data-support-roflumilast-cream-infants-eczema-over-4-weeks-lawrence-eichenfield-md

In this segment of his interview, Eichenfield highlights the safety and tolerability of roflumilast cream for children with atopic dermatitis in INTEGUMENT-OLE.

Roflumilast Cream 0.05% Well Tolerated in Children with Eczema, With Lawrence Eichenfield, MD

Long-Term Safety of Roflumilast Cream for Children, With Lawrence Eichenfield, MD

New long-term INTEGUMENT-OLE open-label extension trial data reinforce roflumilast cream .05% (ZORYVE) as a durable, well-tolerated non-steroidal medication for children aged 2 - 5 years living with 

, with efficacy continuing to build over the full 56-week study period.

In the second half of his discussion with the team at 

, Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego, highlighted what those new results could mean in practice and their significance among this patient population.

One of the most clinically notable observations from the extension study was that efficacy did not plateau after initial response. The continued to improve over time, and Eichenfield pointed to this trajectory as a reflection of the sustained anti-inflammatory action of roflumilast as a topical PDE4 inhibitor. While the earlier 4-week INTEGUMENT-PED trial established differentiation from vehicle, this longer observation window demonstated patients who had not yet attained clear or almost-clear status at the 4-week mark continued to improve as the drug’s use continued.

Even children who had been on vehicle in the initial trial and subsequently crossed over to active treatment caught up relatively quickly, Eichenfield highlighted. Beyond direct inflammation suppression, Eichenfield also described the mechanism as working to improve patients’ skin barriers and reducing their levels of pruritus. This effectively de-amplifyies the interconnected cycle of inflammation, dysfunction of barrier, and itch representing patients’ atopic dermatitis-related burdens.

On the question of tolerability, a heightened concern given the body surface area-to-weight ratio in toddlers and preschoolers, Eichenfield characterized these new findings as reassuring. More than 97% of those evaluated showed no evidence of local irritation at any evaluation point across the 56-week period, he noted, and caregiver-reported stinging or burning was documented in fewer than 1.8% of children at any single point in time.

Additionally, Eichenfield distinguished between tolerability and safety as distinct dimensions. He described, on the safety side, treatment-emergent adverse events, such as upper respiratory infections at 8.7%, pyrexia, and nasopharyngitis, as occurring at consistent rates with what is expected in any cohort of 2- to 5-year-olds followed over a full year. Eichenfield described serious adverse events as rare, noting a lack of such events being deemed treatment-related.

Contextualizing these data within the broader management landscape, Eichenfield pointed to this age group as having had historically very few approved non-steroidal medication options, while carrying a disproportionately high disease burden. He acknowledged concerns about topical corticosteroids, whether fully warranted or not, are a real-world driver of hesitancy among caregivers. Having a therapy designed for clinicians and families to use as needed with genuine comfort, Eichenfield argued, has the potential to meaningfully shift how well atopic dermatitis is controlled early in life.

Smith T. New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children. HCPLive. March 10, 2026. Accessed March 16, 2026. 

https://www.hcplive.com/view/new-long-term-data-announced-roflumilast-cream-atopic-dermatitis-in-children

Eichenfield L. On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD. HCPLive. March 16, 2026. 

https://www.hcplive.com/view/on-new-roflumilast-cream-data-atopic-dermatitis-children-lawrence-eichenfield-md

This segment of Eichenfield's interview highlights long-term safety findings on roflumilast cream .05% for children 2 - 5 years old with atopic dermatitis.

Lawrence Eichenfield, MD

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