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Jamie Restivo, MPAS, PA-C, shares her key takeaways from the first day of the recent Fall Clinical PA/NP Conference in Orlando, Florida.

Clinical Pearls from the 2025 Fall Clinical PA/NP Meeting: Day 1

Maddi Hebebrand is an associate editor of 

and joined the MJH Life Sciences team in May 2024. She attended Baldwin Wallace University, studying Media Production and Film, and received her Masters in Digital Media from Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family. 

Recent research outlined 5 subtypes of vitiligo that can be used to guide therapeutic choices.

Five Clinical Subtypes Identified in Vitiligo Cohort

and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

Alys plans to conduct a phase 1/1b trial assessing the efficacy and safety of the mast cell selective c-Kit inhibitor in the CIndU subtype.

Alys Pharmaceuticals Submits ALY-301 Clinical Trial Application in Germany for Cold Urticaria

Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University Maryland in Baltimore and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

Diagnosing and Managing GPP: Top Insights From the Experts

Dermatology Times connects dermatology professionals with key skin disorder coverage, therapeutic strategies, clinical trial updates, and expert insights.

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Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

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Video Series

Hyperhidrosis is not rare. According to the 

, approximately 385 million people worldwide live with hyperhidrosis.

In fact, they note that the amount of people living with chronic, excessive sweating is even higher than the amount of people living with other dermatologic conditions like psoriasis.

Just how common is hyperhidrosis in real-world comparisons?

The prevalence of hyperhidrosis is much higher in younger populations than in the general population, with 8.8% of individuals between the ages of 18 to 39 years old living with the condition. 

When comparing these statistics to everyday, common occurrences like hair color, the number of people with hyperhidrosis is greater than the 1% of individuals with natural red hair and 2% of individuals with natural blond hair. 

Despite how common hyperhidrosis is, it is estimated that 27% of those with the condition never receive a diagnosis.

 wants to hear from you. What percentage of the global population is estimated to have hyperhidrosis?

 to share your hyperhidrosis insights or research.

Albert. Fact check: Hyperhidrosis - International Hyperhidrosis Society: Official site. Home - International Hyperhidrosis Society. October 24, 1970. Accessed November 16, 2023. 

https://www.sweathelp.org/home/news-blog/542-fact-check-hyperhidrosis.html

Hyperhidrosis affects approximately 385 million people globally, surpassing the prevalence of other dermatologic conditions like psoriasis. It is notably more common in younger populations, with 8.8% of individuals aged 18 to 39 experiencing the condition. Comparatively, hyperhidrosis is more prevalent than natural red or blond hair, which affects 1% and 2% of the population, respectively. Despite its prevalence, 27% of those with hyperhidrosis remain undiagnosed. The article encourages engagement during Hyperhidrosis Awareness Month to share insights and research on the condition.

Click here to answer this week's poll for Hyperhidrosis Awareness Month.

Polls 

POLL: What Percent of the Global Population is Estimated to Have Hyperhidrosis?

Barzolvolimab (CDX-0159) demonstrated rapid symptom reduction in a recent study exploring its efficacy in adult patients with moderate to severe antihistamine-refractory chronic spontaneous urticaria (CSU). 

European Journal of Allergy and Clinical Immunology

 reported high percentages of patients achieving well-controlled and complete responses after treatment with the monoclonal anti-KIT antibody vs placebo.

reported that barzolvolimab reduced disease activity and skin mast cells in patients with chronic inducible urticaria.

The first-in-class anti-KIT mAb has also demonstrated improvements in itch and circulating tryptase, leading researchers to examine its effectiveness in CSU, as well.

Researchers conducted a phase 1b, double-blinded, randomized study (

) evaluating the safety, pharmacokinetics, and pharmacodynamics of barzolvolimab.

 Participants were assigned to receive barzolvolimab or placebo on 1 of 2 dosing schedules: every 4 or 8 weeks. The study included a 2-week screening phase, 12 weeks of treatment, and a 12-week follow-up.

A total of 93.3% (n=42) of patients completed the 12-week treatment phase. The demographic and disease characteristics were balanced across all study arms, with most participants classified as having severe CSU at baseline. Among barzolvolimab-treated patients (n=35), the median age was 49.3 years, and 80% were women. Duration of CSU varied widely, from as little as 0.6 years to more than 6 decades.

Barzolvolimab demonstrated robust and sustained suppression of serum tryptase. Within days of the initial dose, tryptase levels dropped by more than 90% in the 1.5-mg/kg and higher-dose cohorts and remained suppressed throughout the 12-week dosing period.

Clinically meaningful reductions in disease severity were observed in barzolvolimab-treated patients across all cohorts. By week 12, average UAS7 scores declined substantially, with the 3.0-mg/kg and 4.5-mg/kg groups experiencing reductions of 30 to 35 points compared with baseline. In contrast, placebo-treated patients showed minimal change.

A significant proportion of patients receiving 3.0-mg/kg and 4.5-mg/kg barzolvolimab achieved near-complete or complete symptom control. More than 60% of patients in the highest-dose group reached UAS7 scores below 6 by the end of the treatment period. These rates were notably higher than in placebo recipients, none of whom reached full disease control.

Barzolvolimab was generally well-tolerated, with adverse events being mostly mild to moderate in severity. There was no reported indication of cumulative toxicity or worsening safety profile with ascending dose.

"For patients with severe CSU, symptom control can be difficult to attain with available therapies," the study authors wrote. "This study initially characterizes barzolvolimab as a promising novel treatment in antihistamine-refractory CSU."

The study may have been limited by the small sample size of patients and variation in drugs used prior to the study. Moving forward, researchers noted the importance of larger-scale studies of barzolvolimab in chronic inducible urticaria, of which studies of this nature are ongoing.

Maurer M, Metz M, Anderson J, et al. Anti-KIT barzolvolimab for chronic spontaneous urticaria. 

Terhorst-Molawi D, Hawro T, Grekowitz E, et al. Anti-KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria. 

A study of CDX-0159 in patients with chronic spontaneous urticaria. ClinicalTrials.gov. NCT04538794. Updated July 19, 2023. Accessed June 9, 2025. 

https://clinicaltrials.gov/study/NCT04538794?term=NCT04538794&rank=1

Barzolvolimab (CDX-0159) has shown promising results in reducing symptoms in patients with moderate to severe antihistamine-refractory chronic spontaneous urticaria (CSU). In a phase 1b study, barzolvolimab demonstrated significant suppression of serum tryptase and substantial reductions in disease severity, with many patients achieving near-complete symptom control. The treatment was well-tolerated, with mostly mild to moderate adverse events. Despite the study's small sample size, these findings suggest barzolvolimab as a potential novel treatment for severe CSU, warranting further investigation in larger-scale studies.

The monoclonal anti-KIT antibody exhibited promise in adults with moderate to severe antihistamine-refractory CSU.

Barzolvolimab Demonstrates Rapid Symptom Reduction in Chronic Spontaneous Urticaria

 conference in Nashville, Tennessee, Eli Lilly and Company shared final results from the phase 3b ADmirable trial of lebrikizumab (Ebglyss).

This is the first study to evaluate lebrikizumab’s effectiveness and safety in adult and adolescent patients with pigmented skin and atopic dermatitis (AD), as this population is typically underrepresented in clinical trials.

) included 90 patients 12 years and older (weight: ≥ 40 kg) with moderate to severe AD and pigmented skin, according to the Fitzpatrick skin type scale (IV, V, or VI). Participants self-identified as Black or African American, Asian, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander. The mean age of patients was 40.7 years. Approximately 43.3% of participants had a Fitzpatrick skin phototype of IV.

"Skin pigmentation matters in evaluating patients with atopic dermatitis, because from a medical perspective, the disease presents differently in darker skin tones vs lighter (eg, redness can be more subtle, pigmentation more prominent, and diagnosis and evaluation more challenging). Additionally, in the next 20 years, people who identify as American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian, or other Pacific Islander are projected to represent more than half of all Americans, which drives our urgency to invest in clinical research that helps address longstanding medical gaps in these populations. ADmirable is the first dedicated study to evaluate the efficacy and safety of Ebglyss in adult and adolescent patients with AD in these patients frequently underrepresented in clinical trials," said Anabela Cardoso, MD, senior vice president of immunology medical affairs at Eli Lilly and Company, in an interview with 

The patients received lebrikizumab 250 mg (500-mg loading dose at baseline and week 2) subcutaneously every 2 weeks for 16 weeks. Then, from weeks 16 to 24, those who responded to treatment received lebrikizumab 250 mg once every 4 weeks; those with inadequate response continued with the dosage every 2 weeks.

Respondents were defined as having an Investigator’s Global Assessment score of 0 or 1 with a 2-point or greater improvement (IGA 0/1) or 75% or greater improvement in Eczema Area and Severity Index (EASI 75). The primary end point of the study was achieving an EASI score of 75 at week 16. Secondary end points revolved around safety and efficacy using PDCA Derm, assessing cutaneous postinflammatory hyperpigmentation and hypopigmentation.

Approximately 68.9% of patients began the trial with moderate disease (IGA = 3) with a mean EASI of 26.4 and an average Pruritus Numeric Rating Scale (NRS) score of 7. At week 16, EASI 75, EASI 90, and IGA 0/1 were achieved by 69.2%, 44.9%, and 44.9% of patients, respectively. This includes more than 88% of patients with the darkest skin tones (Fitzpatrick V and VI). Approximately 73% of respondents were able to switch to a once-monthly maintenance dose after 16 weeks.

Nearly 60% of patients observed a 4-point or greater improvement in Pruritus NRS. These numbers increased at week 24 with EASI 75, EASI 90, and IGA 0/1 achieved by 78.4%, 47.3%, and 54.1% of patients, respectively. Moreover, 61.5% of participants had a 4-point or greater Pruritus NRS improvement.

Additionally, 4-point or greater improvements in the Dermatology Life Quality Index were reached by 71.7% and 72.9% of patients at weeks 16 and 24, respectively. More than 64% of patients with hyperpigmented lesions and 25% with hypopigmented lesions showed improvement after 24 weeks. Most treatment-emergent adverse effects were mild or moderate, with only 1 reported case of conjunctivitis and injection site reaction. None of the adverse events were serious, and the drug did not need to be discontinued. This safety profile is consistent with previous long-term trials of lebrikizumab, regardless of dosage and frequency.

Overall, patients with skin of color and moderate to severe AD severity responded well to lebrikizumab after 24 weeks, with improvements in symptoms such as itch and hyperpigmentation. Response was noted as early as week 16 and continued to improve throughout the trial with a favorable safety profile.

"These new, 24-week data from ADmirable—the first dedicated study for evaluating the efficacy and safety of Ebglyss in adult and adolescent patients with pigmented skin and moderate-to-severe atopic dermatitis—reinforce the efficacy and safety of Ebglyss as a first-line biologic, following prescription topicals, with once-monthly maintenance dosing after the 4-month initial dosing for adults and adolescents, regardless of skin tone. These add to the robust and extensive data supporting Ebglyss's value for a broad range of patients with moderate to severe atopic dermatitis," Cardoso concluded.

1. Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: final 24-wWeek results from the phase 3b, open-label ADmirable study. Presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, TN.

2. Lilly's Ebglyss (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at 3 years in half of patients with moderate-to-severe atopic dermatitis. News release. Eli Lilly. March 7, 2025. Accessed June 7, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyssr-lebrikizumab-lbkz-single-monthly-maintenance

Lebrikizumab demonstrated efficacy and safety in treating moderate-to-severe atopic dermatitis (AD) in patients with pigmented skin, a group often underrepresented in clinical trials. The phase 3b ADmirable trial included 90 participants aged 12 and older, with significant improvements observed in Eczema Area and Severity Index (EASI) and Pruritus Numeric Rating Scale (NRS) scores by week 16, which further improved by week 24. The study reported a favorable safety profile, with most adverse effects being mild or moderate, and no serious events necessitating discontinuation of the drug.

At RAD 2025, Eli Lilly revealed promising results for lebrikizumab in treating atopic dermatitis in patients with skin of color.

Late-Breaking Data: Lebrikizumab Demonstrates Efficacy in Patients With Skin of Color With AD

Ruth is a 45-year-old woman presenting with severe pruritus, erythematous rash, and lichenification across her legs, arms, and abdomen. She has a history of allergic rhinitis and asthma since childhood but no prior history of atopic dermatitis (AD). Ruth recently experienced work-related stress due to a promotion.

Upon further questioning, you learn that Ruth has disturbed sleep due to intense pruritis, hindering ability to be fully present in daily activities. Additionally, she mentions that she has noticed the symptoms and rash are worse when highly stressed, which is common with increased work demands. Ruth has tried multiple over the counter emollients and moderate-potency corticosteroids. Although she was diligent in their application, the rash persisted and she experienced rebound flares when tapering their use. She also mentioned that she was on a topical calcineurin inhibitor for a few months and noticed some improvement.

Ask follow up questions to determine whether stress is short-term, long-term, and/or spurred by a traumatic event

Try a different treatment option, such as dupilumab or tralokinumab

How do you approach a case that may be exacerbated by stress? We would love to hear from you. Email 

Ruth, a 45-year-old woman, presents with severe pruritus, erythematous rash, and lichenification, with a history of allergic rhinitis and asthma but no prior atopic dermatitis. Her symptoms, exacerbated by stress, have led to disturbed sleep and impaired daily functioning. Despite using over-the-counter emollients, corticosteroids, and a topical calcineurin inhibitor, her condition persists with rebound flares. The case highlights the potential impact of stress on dermatological conditions and the challenges in managing stress-related exacerbations in patients with similar profiles.

The case of a 45-year-old woman with AD challenges clinicians on how to consider stress as an exacerbating factor in a treatment-resistant case.

DermIQ 

Evaluating Stress Levels in AD Treatment Plans

New evidence suggests that dupilumab (Dupixent; Regeneron and Sanofi) not only alleviates the physical symptoms of moderate to severe atopic dermatitis (AD) but also substantially improves various facets of patients’ everyday lives. The data, presented as a poster at the 

 Conference held in Nashville, Tennessee, reported improvements in quality of life, including mental health and social functioning.

Given the persistent symptoms and significant disease burden of AD,

 this often leads to what clinicians refer to as cumulative life course impairment (CLCI).

 CLCI encompasses the long-term, often irreversible impacts on education, employment, family life, mental health, and social engagement resulting from ongoing disease activity. 

Despite the widespread use of biologics such as dupilumab, there is limited data on how effective treatment may mitigate these broader life impacts. To address this gap, the research team conducted a qualitative, in-depth analysis involving 50 adult patients with moderate to severe AD who had been treated with dupilumab. 

The study involved semi-structured interviews analyzed using qualitative software (ATLAS.ti), aiming to identify common themes and quantifiable patient-reported outcomes related to life improvements following treatment. Participants were interviewed individually for up to an hour, focusing on their experiences before and after initiating therapy across various domains, including relationships, employment, mental health, leisure activities, and social participation.

Results showed notable enhancements across multiple life domains post-dupilumab initiation. For instance, 92% of patients reported improved daily life and leisure activities, while 30% experienced less medication burden. 

Patients also noted greater freedom in clothing choices (62%) and improved diet due to fewer food allergies or reactions (30%). Psychologically, participants experienced decreases in stress, anxiety, depression, and stigma, with 66% reporting increased happiness and 78% citing reduced stress or worry.

Socially, more than a quarter noted easier pathways to making friends (16%) and initiating romantic relationships (14%). Moreover, improvements extended to family life and personal well-being; 30% cited better interactions, and 42% observed positive effects on friendships. 

Overall, belief in the therapy’s broad benefits was strong, emphasizing that beyond symptom relief, patients felt more confident, engaged, and hopeful.

The data collection emphasized responses where at least 6% or 10% of participants reported noteworthy improvements, highlighting the comprehensive scope of dupilumab's impact.

Findings from this qualitative analysis suggest that dupilumab’s benefits extend well beyond skin symptom control, addressing long-standing, often overlooked aspects of patient quality of life associated with CLCI. 

However, some limitations exist, including reliance on patient self-reporting and potential recall bias. 

Future research may explore longitudinal effects, optimal timing of intervention, and the potential for early biologic therapy to prevent or reverse CLCI. Additionally, integrating patient-reported outcomes into clinical practice can help tailor treatment plans to target broader life impacts, ultimately improving holistic patient care.

"Early use of effective AD treatment in patients with moderate to severe AD may reduce the effects of CLCI," wrote poster authors Kimball et al. 

Kimball AB, Martins B, Holub A, et al. Impact of dupilumab on the lives of patients with moderate to severe atopic dermatitis. Poster presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, Tennessee.

Fasseeh AN, Elezbawy B, Korra N, et al. Burden of atopic dermatitis in adults and ddolescents: a systematic literature review. 

von Stülpnagel CC, Augustin M, Düpmann L, da Silva N, Sommer R. Mapping risk factors for cumulative life course impairment in patients with chronic skin diseases - a systematic review. 

New evidence indicates that dupilumab significantly enhances the quality of life for patients with moderate to severe atopic dermatitis, beyond alleviating physical symptoms. The study, presented at the 2025 Revolutionizing Atopic Dermatitis Conference, involved qualitative interviews with 50 patients, revealing improvements in mental health, social functioning, and daily activities. Participants reported reduced stress, anxiety, and depression, alongside increased happiness and social engagement. Despite limitations like self-reporting bias, the findings suggest dupilumab's potential to address cumulative life course impairment, warranting further research into its long-term benefits.

Data presented at the 2025 RAD Conference shows dupilumab improves daily functioning, mental health, and social aspects in patients with atopic dermatitis.

Sponsored by Allergan Aesthetics

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