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Previous population-based studies in the United States found racial/ethnic differences of atopic dermatitis (AD) severity and treatment patterns. It is unclear whether these differences are from differences of disease characteristics or disparities. To examine racial/ethnic differences in severity and treatment patterns in a diverse outpatient patient cohort of AD patients (n = 833). There were no significant associations of highest-reported body surface area (BSA; Fisher's exact test, P = 0.19 and P = 0.44) or physician's global assessment (PGA; P = 0.63 and P = 0.57) with race or ethnicity; nor interactions of race/ethnicity with gender or age as predictors of BSA or PGA. Asian and multiracial/other patients were more likely than White or Black patients to use topical calcineurin inhibitors (Chi-square, P = 0.01). Dupilumab use differed by race (Multiracial/other = 35.0%; White = 20.1%; Asian = 15.7%; Black = 13.6%; Chi-square, P = 0.03), but not ethnicity (P = 0.88). Use of oral corticosteroids (Chi-square, P = 0.74), immunosuppressants (P = 0.98) or GABAergics (P = 0.16) or NBUVB (P = 0.42) did not differ by race. There were no interactions of race/ethnicity with gender or age as predictors of treatment use. Similar treatment patterns were observed across racial/ethnic groups. Though, topical calcineurin inhibitors were more commonly used in Asian and multiracial/other patients; dupilumab use was more common in multiracial/other patients. [ABSTRACT FROM AUTHOR]

Black race is associated with increased atopic dermatitis (AD) severity and healthcare resource utilization. However, the burden of out-of-pocket (OOP) expenses among black individuals with AD is not well understood. We sought to characterize the categories and impact of OOP healthcare expenses associated with AD management among black individuals. A 25-question voluntary online survey was administered to National Eczema Association members (N = 113,502). Inclusion criteria (US residents age ≥ 18 years; self-report of AD or primary caregivers of individuals with AD) was met by 77.3% (1118/1447) of respondents. Black individuals with AD were younger, had lower household income, Medicaid, urban residence, poor AD control and frequent skin infections (P ≤ 0.02). Blacks vs. non-blacks reported more OOP costs for prescription medications covered (74.2% vs. 63.6%, P = 0.04) and not covered (65.1% vs. 46.5%, P = 0.0004) by insurance, emergency room visits (22.1% vs. 11.8%, P = 0.005), and outpatient laboratory testing (33.3% vs. 21.8%, P = 0.01). Black race was associated with increased household financial impact from OOP expenses (P = 0.0009), and predictors of financial impact included minimally controlled AD (adjusted OR [95% CI] 13.88 [1.63–117.96], P = 0.02), systemic therapy (4.34 [1.63–11.54], 0.003), > $200 monthly OOP expenses (14.28 [3.42–59.60], P = 0.0003), and Medicaid (4.02 [1.15–14.07], P = 0.03). Blacks with Medicaid had higher odds of harmful financial impact (3.32 [1.77–6.24], P = 0.0002) than those of black race (1.81 [1.04–3.15], P = 0.04) or with Medicaid (1.39 [1.02–1.88], P = 0.04) alone. Black race is associated with increased OOP costs for AD and significant household financial impact. Targeted interventions are needed to address financial disparities in AD. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a chronic pruritic skin disease that can have a profound negative impact on patients' quality of life, especially in cases of inadequate disease control. Dupilumab, a dual inhibitor of IL-4 and IL-13 signaling, is approved in the United States for the treatment of moderate-to-severe AD in adults (≥ 18 years old) and in children (≥ 6 years old). In this review, we present results from phase 3 trials evaluating dupilumab's efficacy and safety in adults, adolescents, and children. These trials demonstrate that dupilumab provides rapid improvements (in as little as 1 week) and sustained efficacy (up to 4 years) when used as a treatment for moderate-to-severe AD. Dupilumab not only improves skin signs and symptoms, but also provides multiple health benefits beyond the skin, including improvements in quality of life, itch, sleep disturbances, and pain/discomfort. Dupilumab is generally well tolerated, has a favorable safety profile in adults, adolescents, and children, has no serious drug–drug interactions, does not require routine laboratory testing, and is not an immunosuppressant. Taken together, phase 3 trials demonstrate that dupilumab provides rapid and sustained efficacy and is generally well tolerated for the treatment of moderate-to-severe AD across age groups. [ABSTRACT FROM AUTHOR]

Tapinarof cream 1% (VTAMA®) is an aryl hydrocarbon receptor (AhR) agonist that is being developed by Dermavant Sciences Inc. (a subsidiary of Roivant Sciences Inc.) as a once-daily topical treatment for plaque psoriasis and atopic dermatitis. AhR is a ligand-dependent transcription factor that has a role in immune-mediated skin responses. In May 2022, tapinarof cream 1% was approved in the USA for the topical treatment of plaque psoriasis in adults. Tapinarof cream 1% is also being investigated for the treatment of atopic dermatitis. This article summarizes the milestones in the development of tapinarof cream 1% leading to this first approval for the topical treatment of plaque psoriasis. [ABSTRACT FROM AUTHOR]

Atopic Dermatitis (AD) is a chronic, inflammatory skin condition that imposes an enormous personal and economic burden in the United States. Due to the ubiquity of the use of electronic medical records (EMR) in the United States, utilizing such data is critically important to studying common dermatologic diseases, such as AD. Our goal was to create a simple-to-use algorithm applied to EMR data to accurately identify AD patients thereby making it possible to efficiently use EMR data to ascertain and then study individuals with AD. Our results suggest that the algorithm that is most likely to accurately identify AD patients from the EMR based on PPV utilizes ICD-10 code for L20.89, L20.9, or L20.84 in conjunction with a diagnosis code for asthma or allergic rhinitis, treatment code, and dermatology consult code. This approach yields a PPV of 95.00% in our training cohort and 100.00% in our validation cohort. Therefore, future studies can use this algorithm to better assure that a subject has AD for studies of the pathogenesis and/or potential treatment targets of AD. [ABSTRACT FROM AUTHOR]

Previous studies found increased prevalence of childhood atopic dermatitis (AD) in the United States over the past few decades. It is unknown whether the prevalence of AD has plateaued or whether AD comorbidities changed over time. The main objective of this study is to assess the prevalence and secular trends of AD and its comorbidities. We analyzed data on 259,818 children, ages 0 to 17 years, from the National Health Interview Survey, 1997–2018, using logistic regression models. The prevalence (95% confidence interval) of childhood AD steadily increased from 2000 [7.3% (6.8–7.9%)] to 2011 [12.8% (12.1–13.5%)] and remained consistent until 2018 [12.6% (11.6–13.5%)]. In logistic regression models, the odds of AD were significantly increased in all years from 2003 to 2018 compared to 1997. However, the increased odds of AD over time were attenuated when adjusting for socio-demographic factors. AD prevalence increased in most socio-demographic groups, but changed variably by age group, race/ethnicity, and region. There were significant trends of AD comorbidities over time, with increasing prevalence of attention deficit (hyperactivity) disorder, and decreasing prevalence of hay fever and depression/sadness. AD prevalence in US children increased between 1997 and 2011, remaining consistent until 2018 with an overall increase of 59%. Prevalence of comorbid hay fever and sadness/depression decreased, while ADD/ADHD increased. Given divergent trends of AD prevalence by socio-demographic characteristics, future studies are better equipped to identify contributing factors of prevalence change. [ABSTRACT FROM AUTHOR]

Population-based risk-factors for the rising prevalence of childhood atopic dermatitis (AD) in the United States are not well elucidated. We hypothesized that trends of birthweight over the past 2 decades contributed to the increasing prevalence of childhood AD in the United States. We sought to determine whether trends of birthweight were associated with trends of childhood AD prevalence over time in the US. Data were analyzed from the 1997–2018 National Health Interview Survey (N = 238,767 children). The prevalence [95% confidence interval] of childhood AD increased from 1997 (7.9% [7.4–8.5%]) to 2018 (12.6% [11.6–13.5%]). Whereas, mean [95% confidence interval] birthweight decreased from 1997 (3.35 kg [3.34–3.37 kg]) to 2018 (3.30 kg [3.28–3.31 kg]). A 1 kg increase in birthweight was associated with a slightly increased odds of AD (adjusted odds ratio [95% confidence interval] 1.039 [1.009–1.070]). However, there were no significant interactions between low or high birthweight and year as predictors of childhood AD prevalence overall or in any age group. In conclusion, there is a slight association between greater birthweights and AD prevalence. However, temporal trends of birthweight do not account for trends of childhood AD prevalence in the United States. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a common inflammatory dermatologic disease clinically characterized by intense itch, recurrent eczematous lesions, and a chronic or relapsing disease course. Mild-to-moderate AD can be controlled by using moisturizers and topical immunomodulators such as topical corticosteroids and calcineurin inhibitors. If topical therapies fail, phototherapy and systemic immunosuppressant therapies, such as ciclosporin, methotrexate, and azathioprine, can be considered. However, relapse and side effects could still occur. The pathogenesis of AD involves epidermal barrier dysfunction, skin microbiome abnormalities, and cutaneous inflammation. Inflammatory mediators, such as interleukin (IL)-4, IL-13, IL-31, IL-33, IL-17, IL-23, and thymic stromal lymphopoietin, are involved in AD development. Therefore, a series of biological agents targeting these cytokines are promising approaches for treating AD. Dupilumab is the first biological agent approved for the treatment of AD in patients aged 6 years and older in the United States. Tralokinumab, lebrikizumab, and nemolizumab have also been confirmed to have significant efficacy against AD in phase III or IIb clinical trials. Also, fezakinumab was effective in severe AD patients in a phase IIa trial. However, phase II trials of ustekinumab, tezepelumab, etokimab, secukinumab, and omalizumab have failed to meet their primary endpoints. Phase II trials of GBR 830 and KHK 4083 are ongoing. In general, further studies are needed to explore new therapeutic targets and improve the efficacy of biological agents. [ABSTRACT FROM AUTHOR]

Chronic inflammatory skin diseases (CISD) represent a significant burden of skin disease in the United States, and a growing number of studies demonstrate that CISD are associated with multiple comorbidities. However, few studies examined multimorbidity in adults with CISD. We sought to determine whether hospitalized US adults with chronic inflammatory skin disorders have increased multi-morbidity and mortality risk. Data from the 2002–2012 Nationwide Inpatient Sample were analyzed, including a representative 20% sample of US hospitalizations. Charlson comorbidity index (CCI) and mean estimated 10-year survival were calculated. Multivariable linear regression models were constructed with CCI score and mean estimated 10-year survival as the dependent variables and chronic inflammatory skin diagnosis, age and sex as the independent variables. CCI scores were significantly higher in bullous pemphigoid (P = 0.0005) and dermatomyositis (P < 0.0001), lower in hidradenitis suppurativa (P < 0.0001), pemphigus (P < 0.0001), rosacea (P < 0.0001), and not significantly different in atopic dermatitis, alopecia areata, and lichen planus compared to psoriasis. Conversely, the mean estimated 10-year survival was higher in pemphigus (P = 0.0451), lichen planus (P = 0.0352), rosacea (P < 0.0001), lower in bullous pemphigoid and dermatomyositis (P < 0.0001), and similar in atopic dermatitis, alopecia areata, and hidradenitis suppurativa compared to psoriasis. Each CISD had a distinct profile of comorbidities when compared to psoriasis. Hospitalized adults with multiple CISD have increased multimorbidity and decreased 10-year survival. Further studies are needed to develop multidisciplinary strategies aimed at preventing and treating multimorbidity, especially modifiable cardiovascular factors in adults with CISD. [ABSTRACT FROM AUTHOR]

Background: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). Objectives: The aim of this study was to evaluate the safety, effectiveness, and pharmacokinetics (PK) of crisaborole in infants aged 3 to < 24 months with mild-to-moderate AD in an open-label study. Methods: Infants (3 to < 24 months) with Investigator's Static Global Assessment (ISGA) of mild (2) or moderate (3) and percentage of treatable body surface area (%BSA) ≥ 5 received crisaborole twice daily for 28 days; a cohort with moderate AD per ISGA and %BSA ≥ 35 were included in a PK analysis. Endpoints included safety (primary), efficacy, and PK (exploratory). Results: Included were 137 infants total (mean age [SD], 13.6 months [6.42]), with 21 in the PK cohort (12.7 months [6.58]). Treatment-emergent adverse events (TEAEs) were reported for 88 (64.2%) patients (98.9% rated as mild/moderate). TEAEs were considered treatment-related for 22 patients (16.1%); most frequently reported were application site pain (3.6%), application site discomfort (2.9%), and erythema (2.9%). ISGA clear/almost clear with ≥ 2-grade improvement at day 29 was achieved by 30.2% of patients. From baseline to day 29, mean percentage change in Eczema Area and Severity Index score was − 57.5%, and mean change in Patient-Oriented Eczema Measure total score was − 8.5. Crisaborole systemic exposures in infants were characterized and, based on nonlinear regression analysis, were comparable with that in patients aged ≥ 2 years. Conclusions: In this open-label study, crisaborole was well tolerated and effective in infants (3 to < 24 months) with mild-to-moderate AD with systemic exposures similar to patients aged ≥ 2 years. Clinical Trial Registration: NCT03356977. [ABSTRACT FROM AUTHOR]

Recent epidemiological studies found the US prevalence of atopic dermatitis in adults to be approximately 7%. In particular, one in four adults with atopic dermatitis report adult onset of their disease. Adult-onset compared to child-onset atopic dermatitis is associated with distinct risk factors, lesional distribution and morphology, associated signs, genetics, and comorbidities. Adult-onset atopic dermatitis is a clinical diagnosis, and must be distinguished from other entities in the differential diagnosis, e.g., allergic contact dermatitis and cutaneous T-cell lymphoma. Further research is necessary to better understand the pathogenesis and optimal treatment approaches in adult-onset/recurrent atopic dermatitis. [ABSTRACT FROM AUTHOR]

Introduction: Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated.Methods: Adult AD patients in the Commercial (n = 83,106), Medicare (n = 31,060), and Medi-Cal (n = 5550) databases were matched (1:1) to non-AD controls by demographic characteristics. AD patients were stratified by disease severity (higher, lower) using treatment as a surrogate measure of severity. The comorbidity burden, HCRU, and costs were evaluated during a 12-month follow-up period.Results: In the Commercial, Medicare, and Medi-Cal populations, patients with AD had a significantly higher overall comorbidity burden (P < 0.0001), an increased risk of asthma and allergic rhinitis (both P < 0.0001), higher HCRU (P < 0.05), and higher mean total per patient costs (Commercial: US$10,461 versus US$7187; Medicare: US$16,914 versus US$13,714; Medi-Cal; US$19,462 versus US$10,408; all P < 0.0001), compared with matched non-AD controls. Higher disease severity was associated with an increased comorbidity burden (P < 0.0001), HCRU (P < 0.05), and total costs (Commercial: US$14,580 versus US$7192; Medicare: US$21,779 versus US$12,490; Medi-Cal; US$22,123 versus US$16,639; all P < 0.0001) relative to lower severity disease.Conclusion: In this large-scale, healthcare claims database analysis, AD patients had a significantly higher comorbidity burden, HCRU, and costs compared with matched non-AD controls. Higher disease severity was associated with an even greater comorbidity and economic burden.Funding: Sanofi and Regeneron Pharmaceuticals, Inc. [ABSTRACT FROM AUTHOR]

Information on several papers discussed at the annual meeting of American Academy of Dermatology held March 3-7, 2017, on the invention of advanced technologies for the treatment of various skin and hair diseases including acne rosacea and other infections. Particular focus is given to the updates in atopic dermatitis and psoriasis.

Background: The use of expert opinion is widespread in economic studies of healthcare utilisation; however, few studies have attempted to assess the validity of assumptions derived from such sources. Objective: To examine the use of such expert opinion in determining comorbidities associated with atopic dermatitis/eczema (AD/E), which were assessed as part of a recent third-party payer cost-of-illness study. Design: To identify the disease-related comorbidities that would represent costs associated with AD/E, physicians on an expert panel were asked individually and then collectively to group all International Classification of Diseases, 9[sup th] Edition–Clinical Modification (ICD-9-CM) diagnosis codes as ‘most likely’, ‘possibly’ or ‘definitely not’ related to the costs of identifying and treating patients with AD/E. Claims representing $US464 million in payer reimbursements from nearly 125 000 patients with AD/E were identified within two separate claims databases (1997 values). Over 850 ICD-9-CM diagnosis codes were identified in the first-listed position from these claims. For each group of ‘most likely’, ‘possibly’ and ‘definitely not’ related diagnosis codes, prevalence rates were compared within AD/E and non-AD/E populations from the two historical payer claims databases. Adjusted and non-adjusted odds ratios were calculated by comparing prevalence rates between AD/E and non-AD/E patients in the same payer population. Results: The mean prevalence rate of any diagnosis code in the AD/E population was 0.65 ± 1.82% (SD) with a mean odds ratio of 1.81 ± 0.96. Comorbidities considered by the expert panel ‘most likely’ to be associated with AD/E had higher prevalence rates (3.28 ± 3.63%) and odds ratios (2.14 ± 1.14). Comorbidities considered to be ‘possibly’ related to AD/E had prevalence rates and odds ratios of 3.01 ± 5.06% and 1.84 ± 0.82, respectively. Comorbidities considered to be ‘definitely not’ related to AD/E had the lowest prevalence rates (0.45 ± 1.09%) and odds ratios (1.80 ± 0.97). Conclusions: Comparing the result of consensus panels with actual claims histories validated the use of expert opinion in determining comorbidities associated with AD/E. Expert opinion yielded valid results in terms of identifying comorbidities that manifested frequently and disproportionately in the AD/E population. Limited statistical measurements of comorbidities would have been less specific than expert opinion. Future cost-of-illness studies should consider alternative data sources and methodologies to enhance the validity and importance of expert opinion and to corroborate their findings. [ABSTRACT FROM AUTHOR]

Information about the topics at 72nd Annual Meeting of the American Academy of Dermatology is presented. The topics include pediatric atopic dermatitis, rosacea therapies, and melanoma therapeutics. The event was participated from over 16,000 attendees and included over 400 educational sessions from international leaders in the field of dermatology.

Background: Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures. Methods: This mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 – 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their 'worst' itch and 'worst' skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data. Results: In the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their 'average' itch/itching in the past 24 h, rather than their 'worst' itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors. Conclusions: Itching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD. [ABSTRACT FROM AUTHOR]