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Atopic Dermatitis Provider Toolkit

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Dermatology Hot Topics

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Nemolizumab, an interleukin-31 (IL-31) alpha antagonist, demonstrated rapid onset of efficacy for pruritus and sleep disturbance in patients with moderate-to-severe atopic dermatitis, according to results from 2 pivotal phase 3 clinical trials. The ARCADIA 1 and ARCADIA 2 studies showed statistically significant improvements in both symptoms within 1 or 2 days of treatment initiation when nemolizumab was added to topical corticosteroids with or without topical calcineurin inhibitors. Results of the study, which was led by Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at the George Washington University School of Medicine and Health Sciences, in Washington, DC, were presented as a poster at the Revolutionizing Atopic Dermatitis meeting, June 6-7, 2025 in Nashville, TN. 

Nemolizumab targets the IL-31 pathway, which mediates both pruritus and inflammation in atopic dermatitis. Previous studies established the IL-31 inhibitor's efficacy and safety profile through 48 weeks of treatment, with sustained improvements in pruritus, skin lesions, and sleep quality maintained at Week 16 and Week 48 endpoints. The current study specifically assessed the  speed of onset of itch and sleep response with the addition of nemolizumab. 

The ARCADIA studies were identical, randomized, placebo-controlled tirals conducted across multiple international sites. Participants aged 12 years and older with moderate-to-severe atopic dermatitis received either 30 mg nemolizumab or placebo every 4 weeks in addition to standard topical therapy, with randomization occurring in a 2:1 ratio favoring active treatment. 

In ARCADIA 1, participants treated with nemolizumab showed significantly greater least squares mean change from baseline in Peak Pruritus Numerical Rating Scale (PP NRS) scores by day 1 compared to those receiving placebo (-0.9±0.06 vs -0.5±0.08, 

<.001). Similar early efficacy was seen in ARCADIA 2,  with nemolizumab-treated participants experiencing greater pruritus reduction (-1.1±0.07 vs -0.4±0.10, 

Responder analyses using the clinically meaningful threshold of ≥4-point improvement in PP NRS revealed that 9.4% of nemolizumab patients in ARCADIA 1 achieved this endpoint by day 2, compared to 3.4% of placebo recipients (

<.001). In ARCADIA 2, 8.2% of treated patients reached this threshold by Day 1, versus 1.9% of placebo patients (

Silverberg et al reported that sleep outcomes measured by the Sleep Disturbance Numerical Rating Scale mirrored improvements in pruritis. In ARCADIA 1, 8.7% of nemolizumab-group participants achieved ≥4-point improvement by day 2 compared to 4.0% of placebo-treated participants (

<.001). In ARCADIA 2, 10.0% of treated patients reached this endpoint by day 1 versus 2.6% of placebo recipients (

The research team concluded that nemolizumab plus topical corticosteroids with or without topical calcineurin inhibitors produces rapid, statistically significant, and clinically meaningful improvements in pruritus and sleep disturbance within two days in patients with moderate-to-severe atopic dermatitis. This rapid onset addresses the clinical need for faster symptom relief in this patient population, where pruritus significantly impacts quality of life and sleep quality.

The findings contribute to the growing evidence base for IL-31 pathway inhibition in atopic dermatitis treatment, particularly regarding the temporal relationship between treatment initiation and symptom improvement. The consistent results across both pivotal studies support the reproducibility of the rapid efficacy profile observed with nemolizumab therapy.

For more RAD 2025 meeting coverage, please click here.

RAD 2025: Nemolizumab as adjunctive therapy to topical steroids with/without   topical calcineurin inhibitors provided rapid relief in moderate-to-severe atopic dermatitis. 

Clinical Topics

Nemolizumab Improves Pruritis, Sleep Within 2 Days When Added to Standard Topical Therapy for Atopic Dermatitis

topical Janus kinase (JAK) inhibitor ruxolitinib 

cream (Opzelura; Incyte) for treatment of pediatric patients aged 2 to 11 years with mild-to-moderate 

(AD). The agency's decision, announced September 18, makes ruxolitinib the first topical JAK inhibitor approved for this pediatric age group in the US.

The approval expands the treatment's previous indication for adolescents aged 12 and older and adults with AD and for individuals 12 years and older with nonsegmental vitiligo. The new indication provides clinicians with a long-anticipated, 

 option for younger children, Incyte noted in a statement.

“Children currently have limited treatment options to meet their specific needs,”  Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine, commented in the statement.

 “With this approval, we now have a new, nonsteroidal topical option that expands how we care for kids with this chronic disease. This is a meaningful step forward and marks a significant advancement in our ability to better support our pediatric patients.”

Atopic dermatitis (AD) is the most common form of eczema, affecting an estimated 2–3 million U.S. children ages 2–11 and more than 21 million Americans aged 12 and older.

 Symptoms, which include itchy, inflamed, and sometimes oozing or crusted patches, can significantly disrupt quality of life and increase susceptibility to secondary infections.

 While topical steroids remain an AD treatment mainstay, chronic or uncontrolled pediatric disease often requires new therapeutic approaches, particularly for families concerned about steroid-related side effects and long-term safety. Although there are other steroid-sparing alternatives, such as topical calcineurin inhibitors and phosphodiesterase-4 inhibitors, their use can be compromised by tolerability or poor efficacy.

TRuE-AD3 enrolled 330 children ages 2 to 11 years who had been diagnosed with mild-to-moderate AD for at least 3 months and qualified for topical therapy. Participants had disease involving 3% to 20% of their body surface area (excluding scalp) and were randomly assigned to be treated with either ruxolitinib cream (0.75% or 1.5%) or vehicle cream twice daily for 8 weeks. The primary endpoint was Investigator’s Global Assessment Treatment Success (IGA-TS) and defined as clear or almost clear skin paired with at least a 2-point improvement from baseline.

At week 8, first author Lawrence Eichenfield, MD, and colleagues reported, results showed significantly greater response rates for children in the active drug group than in the vehicle group: 36.6% with 0.75% cream and 56.5% with 1.5% cream vs 10.8% for vehicle (

More ruxolitinib-treated children also reached the study's secondary endpoints.  More than half achieved at least 75% improvement in Eczema Area and Severity Index score (EASI-75) from baseline (51.5% with 0.75% cream and 67.2% with 1.5% cream vs 15.4% with vehicle). Study authors observed improvements as early as week 2, a positive outcome that extended to patient-reported measures, including the Patient-Oriented Eczema Measure, Infants’ Dermatitis Quality of Life Index, and Children’s Dermatology Life Quality Index.

Pruritis accounts for a substantial burden of disease for children and adults with AD, making improvement an essential test in approval of all new treatments. In TRuE-AD3, itch was reportedly quelled early. The median time to reach a 4-point reduction in itch numerical rating scale scores was 11 to 13 days for participants aged 6 years and older treated with ruxolitinib compared with 23 days for vehicle, according to the study findings.

Importantly, the safety profile was consistent with previous adult and adolescent data, and no new safety signals were observed in the pediatric group. The most common adverse event (AE) was mild pain at the application site, observed among less than 4% of participants. The most common treatment-emergent AE were upper respiratory tract infection and nasopharyngitis. There was no evidence of serious infections, major cardiovascular events, malignancies, and blood clots during the trial,

 although the boxed warning for the JAK inhibitor class effects remains central to clinical decision-making. 

Product labeling also continues to contraindicate use alongside biologics, other JAK inhibitors, or strong immunosuppressants, and comprehensive monitoring is recommended for blood counts and infection risks.

“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day,” Bill Meury, Incyte chief executive officer, said in the statement.

Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2-11 with atopic dermatitis. News release. Incyte. September 18, 2025. Accessed September 19, 2025. https://investor.incyte.com/node/25636/pdf 

Eczema stats. National Eczema Association. Accessed September 19, 2025. https://nationaleczema.org/eczema-facts/ 

Kruse LL, Mancini AJ. Atopic dermatitis in children. 

2024;53(4):e121-e128. doi:10.3928/19382359-20240205-02 

Eichenfield LF, Stein Gold LF, Simpson EL, et al. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: results from TRuE-AD3, a phase 3, randomized double-blind study. 

l. 2025;93(3):689-698. doi:10.1016/j.jaad.2025.05.1385

Incyte announced the agency's decision, which was based on findings of significant reduction in atopic dermatitis signs and symptoms during the TRuE-AD3 clinical trial. 

FDA News

FDA Approves Ruxolitinib for Pediatric Patients Aged 2-11 Years as First Topical JAK Inhibitor for the Age Group

"One thing to keep in mind is that the assessment of cognition provides something that could be described as a cognitive vital sign. It’s as integral and important to assess cognition as it is to check blood pressure, pulse oximetry, or any of the other vital signs that are routinely obtained in a primary care setting."

The Future of the Cognitive Vital Sign 

Neurocognitive researcher David J Libon, PhD, has a strong and positive message about the future of digital cognitive assessment and it sounds like this: It's not outlandish at all to posit that as digital cognitive assessment technology becomes more widely available and it's true value understood, assessment for the very earliest signs of troubled cognition will begin in adults as young as age  45 or 50 years and will be a standard of care—in primary care. The equipment required, an iPad or similar digital device, can be scaled easily and the cost, well, "you can't do an MRI at the drop of a hat," Libon said in a recent interview with 

In the short video above, Libon, joined by his close colleague Rodney Swenson, PhD, talks about the future of the research he and others are conducting now into cognition as a vital sign and how the refined tools available will change the landscape of assessment for and identification and management of cognitive impairment. 

The following transcript has been lightly edited for style and clarity. 

What does the future of your research, or the research at large in the field look like? What are the what are the next avenues for exploration, and do you see any challenges or barriers ahead? 

Well, I think one thing to keep in mind is that the assessment of cognition provides something that could be described as a cognitive vital sign. It’s as integral and important to assess cognition as it is to check blood pressure, pulse oximetry, or any of the other vital signs that are routinely obtained in a primary care setting. I think as digital assessment technology becomes more widely available, understood, and deployed, you're going to see digital cognitive assessments introduced as early as age 45 or 48, certainly by age 50. Depending on how the technology is used and what future research shows, I believe digital platforms have the potential to flag emergent problems earlier than any other method. The scalability and affordability are key advantages. You can't just order an MRI at the drop of a hat—it's expensive and not always available. In contrast, digital assessments are low-cost and accessible.

One thing I'm doing is partnering with colleagues around the country who are conducting longitudinal and epidemiological research. What we’re seeing is that on some of these digital outcome variables, even individuals in their mid-40s or 50s, people whose blood glucose or systolic blood pressure are medically well managed, are still performing less well on certain cognitive parameters. That’s incredibly important. It suggests that digital tools may detect subtle cognitive changes even when traditional health metrics are controlled.

Where I get excited is in thinking about the potential for this technology to become routine in clinical practice. Once the research is completed and the value becomes more widely known, I believe digital cognitive assessment will become a standard part of care, right alongside other vital signs in your doctor’s office.

A cognitive health assessment will soon be as routine as taking blood pressure or pulse oximetry, says neurocognitive researcher David J. Libon, PhD. He talks more about that future. 

Grace Halsey

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