Equitable Management of Atopic Dermatitis: Treatment Considerations Across Patient Populations

In a recent Peer Exchange from The American Journal of Managed Care®, a panel of experts examined the autoimmune foundation of atopic dermatitis and the role of biologics in treatment. The panel addressed the diagnostic challenges and treatment considerations unique to the presentation of atopic dermatitis across different skin pigmentations to ensure equitable clinical outcomes for all patients. They also discussed recent clinical trials evaluating atopic dermatitis in patients with skin of color. The session was moderated by Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of ambulatory pharmacy at Emory Healthcare and Winship Cancer Institute in Atlanta, Georgia.

Understanding Atopic Dermatitis as an Immune-Mediated Disease

Atopic dermatitis (AD), or eczema, is a common, chronic inflammatory disorder that causes skin barrier dysfunction, intense itching, lichenification, and increased risk of cutaneous infection.¹ AD affects up to 20% of children and 10% of adults in high-income countries and has a usual age of onset of 3 to 6 months.^1-3 The disorder affects approximately 230 million people worldwide and has a high disease burden, with approximately 10% to 20% of adults reporting severe disease.^1,4 Patients with AD are at increased risk of comorbidities, including asthma, food allergies, allergic rhinitis, and psychological disorders.¹ AD has a considerable impact on quality of life beyond the hallmark symptom of pruritus, including pain, sleep loss, anxiety, and depression.⁵ Patients can experience frequent secondary bacterial infections, particularly recurrent staphylococcal infections that complicate treatment regimens and increase health care utilization.¹

The pathogenesis of AD is complex and involves inflammatory and neuronal pathways. Compared with healthy skin, clinically unaffected skin has a dysfunctional epidermal barrier with a reduced diversity in the surface microbiome.¹ In the case of an AD acute skin lesion, Langerhans cells and dermal dendritic cells take up allergens and antigens, whereas a weakened or damaged skin barrier in AD promotes inflammation and T-cell infiltration.¹ The skin is susceptible to Staphylococcus aureus infection, which induces further inflammatory responses. The T helper 2 (Th2) cell inflammatory pathway is central to this, leading to increased production of cytokines—including IL-4, IL-13, and IL-31—diminishing barrier function, driving itching, and facilitating dysbiosis in favor of bacterial infection.¹ The Th22/IL-22 pathway is also involved, which contributes to epidermal disruption, ultimately leading to a chronic inflammatory environment.^1,6

Itch is induced by various pruritogens (antigens and molecular mediators such as histamine and type 2 cytokines, including IL-4, IL-13, thymic stromal lymphopoietin, and IL-31). For example, histamine acts on a subset of sensory neurons in the skin that express histamine receptors and the heat- and capsaicin-gated ion channel TRPV1.⁷ Pruritogens induce neuronal excitation and promote itch behaviors via cutaneous pruriceptive primary sensory nerves, which transmit itch signals to the spinal cord and brain.^1,7 Type 2 cytokines are thought to mediate itch in chronic pruritus associated with AD.¹

Current biologic therapies target these specific immune pathways, focusing on IL-4, IL-13, IL-31, and Janus kinase modulation.⁸ Treatment with nemolizumab, a humanized monoclonal antibody targeting IL-31 receptor A, has been shown to significantly improve itch in AD.⁹ Data from phase 3 studies have demonstrated that lebrikizumab, a monoclonal antibody that binds to soluble IL-13 and blocks its signaling, is effective in treating patients with moderate to severe AD.^10,11 These results support the clinical relevance of type 2 immune-neural interactions in AD pathogenesis.^1,9,12

Bispecific antibodies are engineered antibodies designed to simultaneously bind 2 different antigens or epitopes and have the potential to reduce symptoms more effectively than single-target agents.⁸ The fully human monoclonal antibody dupilumab binds specifically to the shared alpha chain subunit of the IL-4 and IL-13 receptors, inhibiting downstream signaling.¹³ Dupilumab has been shown to reduce itch in AD-related pruritus and improve quality of life in findings from phase 3 trials.^1,12-14 Bispecific antibodies in development for AD include GB12-09 and NM26-2198, which target IL-4R and IL-31R and have been shown to reduce inflammation in preclinical trial data.⁸

Stakeholder Insights

April W. Armstrong, MD, MPH, chief of dermatology at the University of California, Los Angeles, said that in addition to inflammation, they are beginning to understand the significance of the neuronal component in AD. “The neuronal component really brought to our understanding [those] patients who, for example, when they have severe AD and they go out to the world, and even just the slightest wind can make their skin feel like it’s burning…, it’s because their skin is so sensitized, so that the nerves in there, the sensory nerves in the skin, are not only larger but also more arborizing with more receptors…sensing the environment.”

“The upstream targeting is so important in dealing with this disease state,” said Mark Makhinson, PharmD, senior director of outpatient and specialty pharmacy at Mount Sinai Health System in New York, New York. “The biologics that are on the market now are really good at targeting that IL-13, IL-30.… You have your dual-targeting products, as well as your single-source products, that really target the IL-30 and the itch modulation.” He added, “The most important piece is to really examine the patient and really use the appropriate product for that patient. And not necessarily start with a topical corticosteroid but go directly into a biologic to improve the patient’s outcomes and decrease further inflammation down the line.”

Health care professionals face significant educational gaps regarding the immune-mediated nature of AD, which directly impacts treatment decisions. Andrew Alexis, MD, MPH, professor of clinical dermatology at Weill Cornell Medicine in New York, New York, described the advanced understanding of immunotherapies as “a blessing and a curse…. Some [practitioners] might feel a little lost in understanding the different biologics that target the specific cytokines…and understanding how the different biologics might have nuances with respect to their efficacy and safety, and figuring out which ones would be suitable for the given patient. And that’s where there can be some educational gaps if you haven’t had an opportunity to dive deep into the subject.”

Andrew Mastro, MS, PA-C, a dermatology physician assistant at Illinois Dermatology Institute in Chicago, emphasized that new-to-practice advanced practice providers (APPs) face challenges in acquiring immunology knowledge, as their educational programs often lack comprehensive coverage of these pathways, and they are “learning everything essentially from a fire hose.” He added that they would need to search out knowledge themselves, be very reliant on their collaborating physician, or gather information through continuing medical education or conferences. “So it’s usually the work that’s being done not 9 to 5, but more 5 to 9, which is really going to get us more up to speed.”

“I think recognizing that there is that heterogeneity, and sometimes we may not be successful at the first try, is actually really important,” Armstrong said. “But the key piece is…telling our patients that we’re willing to work with them to find the medication that’s individualized for them.”

“The benefit of having a clinical pharmacist in practice and seeing the patient [is that] they have a view into the rest of their medications,” said Makinson. “They look at interactions; they look at how the medications work together. There’s emerging research on GLP-1s [glucagon-like peptide 1s] in addition to biologics in the treatment of inflammatory conditions, so having a pharmacist that can pull it all together as part of the care team is so important.”

Mastro discussed the burden, which goes beyond a visible skin condition. “There’s so much at play here, how it affects their work and their life. Do we have to take days off school? Do we have to take days off work? How that impacts us…. The stigma that these patients carry around with them, whether they be pediatric or adult, if they’re getting made fun of in school or if they’re being looked at differently at their workplace or on the way to their workplace, all that plays a role here.” He noted the “significant life cost of carrying around your topicals and being shackled to those. And do they actually ever get a true vacation?”

Diagnostic Approaches and Treatment Strategies Across Diverse Populations

Clinical presentations vary in patients with skin of color, appearing as deep purple, maroon, gray, or other pigmentation changes rather than erythema, which is considered typical in patients with lighter skin tones, and can therefore be missed when assessing AD.¹⁵ Compared with lighter-skinned patients, darker-skinned patients often have perifollicular accentuation and distinct papules on the extensors and trunk.¹⁵ Patients with darker skin types are also at higher risk for developing postinflammatory hyperpigmentation.¹⁵ Asian patients often present with more prominent demarcation of lesions and lichenification than White patients.¹⁵

Significant heterogeneity in immune pathway activation is also evident across racial groups. Although immune responses in patients of European descent tend to be more Th2 focused, broad immune activation, including Th1, Th2, Th17, and Th22 pathways, has been reported in African American patients.¹⁶ In individuals of Asian descent, activation of Th1- and Th17/IL-23–mediated responses has been reported in chronic skin lesions, resulting in what some authors have described as a psoriasis-like phenotype.^1,17 This heterogeneity in immune responses across populations emphasizes the importance of personalized treatment approaches rather than one-size-fits-all strategies for optimal patient outcomes. A thorough understanding of the unique genetic, clinical, and molecular features of AD across a broad range of racial and ethnic AD subtypes is critical as doctors care for an increasingly multinational patient population.¹⁵

Current management of AD may be suboptimal, as only 8% of patients with AD and 7% of patients with severe AD are treated with systemic therapies.¹⁸ A multidimensional approach that uses physician- and patient-reported outcome measures can help determine treatment targets for individual patients.¹⁸ Signs and symptoms unrelated to the skin, such as sleep loss, anxiety, and depression, also need to be taken into account.¹⁸ This requires shared decision-making between patients and physicians to inform treatment choices and optimize management of AD.¹⁸ Clinicians should discuss the results of any outcome measure used with the patient, explaining what these results mean regarding their disease severity and available treatment choices. It is not always possible to achieve “optimal” targets due to limited access to, or availability of, the advanced treatment options, or patient preferences.¹⁸

Atopic dermatitis is chronic, complex, and requires a holistic approach with multidisciplinary management.¹⁹ Patients with moderate to severe AD have an additional disease burden due to comorbidities, including asthma, allergies, and neuropsychiatric disorders.¹⁹ Depending on the symptoms and comorbidities present, a multidisciplinary care team led by a dermatologist may include an allergist; a respiratory medicine specialist; a gastroenterologist; an ophthalmologist; a dietitian; a rheumatologist; a psychologist; a psychiatrist; or an ear, nose, and throat specialist.¹⁹

Stakeholder Insights

“For our patients with skin of color, especially thinking about the postinflammatory dyspigmentation or after the inflammation has gone away,…the skin can be lighter or darker than their native skin tone,…and that stain…can be just as bothersome as the initial inflammation itself,” said Armstrong.

Alexis added, “For complex reasons, we often see delays in access to specialist care in many populations with skin of color. And that can contribute to us seeing more severe disease at the point of care. So we might see more severe lichenification, we might see more papular nodules, we might see more impact on overall quality of life, absenteeism from school, from work, and sleep disturbance, as we’ve talked about.”

Armstrong agreed: “I think we are trying to fill that educational gap, but it is definitely something that we are hoping…more and more clinicians can adopt. Because it’s not something that people typically are exposed to at first. So it does come with more training and experience.”

Fungal disease is a common misdiagnosis, according to Alexis. “Psoriasis can sometimes be hard to differentiate [from] lichen planus and other immune-mediated scaly inflammatory disorders, which can have some overlapping features. And an important one is mycosis fungoides or cutaneous T-cell lymphoma.”

On shared decision-making, Alexis said, “[By] explaining to the patient the pathogenesis of atopic dermatitis, explaining that it’s an immune-mediated disorder and calling out certain factors that affect the barrier and immune dysregulation in layperson’s terms,…I’ll try to make the links between their symptoms and signs, like their itch and their signs on the skin and the mechanisms, in layperson’s terms, and mention that we now have agents that could target the underlying cause or mechanisms of those signs and symptoms.”

“This is a chronic relapse and remitting condition,” said Mastro. “So these patients are coming back and forth to us, and if they’ve come to me already, I’m their fifth provider; my conversation with what’s a moderate or severe patient will change.… Then there’s access, and we deal with that and what kind of insurance plan that they have, and does the drug that I want to put them on have a great co-pay program.Do they have a quick-start program? Can I get them samples? Can I actually put that into their hands? What’s a great therapy if we can’t get it to them? So there [are] so many factors, but in terms of what’s a moderate and severe patient outside of the objective measurements, it really goes a little bit more to the patient-reported outcomes in terms of how I make the decision.”

“With our [patients with] skin of color or different skin tones, photos are going to be the most important,” added Mastro. “So say, hypothetically, that patient comes in, [and] the itch, the burning, all those things are gone, and now we just have the postinflammatory left over. In my non–skin of color patients, am I really photographing all those visits? I’m not. But with the skin of color patients, I take time to take those photos at each individual visit when they do come in, because of the 6-month visit when they’re theoretically well controlled, but they don’t feel like it because they still see the evidence of the remaining marks left over on their skin. We can show pictures and say, ‘Hey, you actually are doing a lot better.’ ”

Mastro continued: “The first question I usually ask is, How are you doing? And when they sit there and talk to me, they will unveil [some] of the details, less about how their itch is, necessarily, or what their skin looks like, but how many days [they] have not thought about [their] atopic dermatitis [or] how many days [they] have forgotten [they] actually have a chronic immune system-driven disease state. And that to me is the kind of ultimate way they can really see control over a long period of time, to give them these so-called…‘drug holidays’ from this thing that they can’t actually get away from.”

“How do I work within the constraints that I’m faced with?” asked Armstrong. “Can I find another therapy that may have very similar efficacy or safety, but perhaps in terms of the frequency of administration is a bit more frequent, but still could be approved by the insurance? But if that’s still not feasible and…I can’t find such an alternate, then I would do a peer-to-peer [consultation], for example, and see if I can get that therapy for the patient.”

She added, “Very importantly also, in all…my patients who are on advanced systemic medications, I [have] almost every single one of them connected. It’s just part of our protocol to be connected with a patient-assistance program. This is really important because it can help save our patients some out-of-pocket costs if they have commercial insurance and also help them navigate foundation support for their therapeutic options. But I think the bottom line is that because atopic dermatitis is such a heterogeneous disease, having more therapies in our toolbox would really help the larger number of patients to benefit [from] the available treatments that we have.”

Makhinson agreed. “It’s what we do on a daily basis, right? Having an integrated care team with a clinical pharmacist, with an in-house specialty pharmacy that is a message away within your EHR [electronic health record] is so important to help the patient through that journey of getting their drug, getting the appropriate drug, supporting you with appeals and peer-to-peers.

“I think the most important piece here is a coordinated care team, and multidisciplinary, where all providers are working together to optimize the patient’s care,” said Makhinson. “Our clinical pharmacists are the ones [who] follow up after a medication is prescribed. We do the financial assistance and prior authorization work to ensure the patient can get on therapy, and then injection training for the patients to ensure that they’re comfortable with self-injection of medication. [We] then follow up…to ensure that there are no [adverse] effects, no unwanted [adverse] effects, or, if there are, how to mitigate them and communicate back to the rest of the care team what the action steps are.”

Armstrong said, “Dermatology conferences oftentimes provide a lot of up-to-date information on management strategies, and we certainly have a lot of those, and many of them are very good in terms of making sure that our clinicians are up to date on all of them. I would say in terms of recognition, diagnosis and improving that skill set, there are 2 website resources that I can suggest. One is called eczemainskinofcolor.org, which has a compendium of different images that clinicians can look at to…get themselves familiarized with what eczema can look like in patients with skin of color. Additionally, the National Eczema Association also has a subpage, within their page, that’s focused on patients with skin of color, where you can take a look at these different images, and there are also case vignettes that talk about management of these patient populations. And I think those can also be helpful resources for our providers.”

“From the APP perspective, the peer-to-peer setting will always be looked upon very fondly by our group,” said Mastro. “These [consultations] allow us to kind of go through our patient narrative, our discussions, what we’re looking at in clinic, a little bit off script, and that allows a little bit more of a collegial conversation in terms of a…‘What would you do?’ or ‘What are you looking at?’ And so the access to those would be more beneficial to us in terms of getting us up to speed quicker.… The case-based round tables, as well, have been fantastic in getting people up to speed.… Having MDs [medical doctors], APPs of all experience levels, in the same room together, they can take notes, and they can take [them] with them back to clinic and put those things into action the next day.”

Alexis agreed and said, “There are visual-based resources of clinical images that one can access, sometimes for free and sometimes with membership. There are large organizations, like the American Academy of Dermatology and the Skin of Color Society, that have electronic modules specifically on skin of color. So these are just some examples in addition to the conferences and webinars that one can go [to] to get more exposure.”

Atopic Dermatitis Clinical Trial Representation: Addressing Historical Gaps and Barriers to Access

Clinical trials in AD have historically underrepresented patients with skin of color, despite the high prevalence and quality-of-life burden, creating significant gaps in understanding treatment efficacy and safety across diverse populations.²⁰ However, the recent clinical trials ADmirable (NCT05372419) and DISCOVER (NCT05590585) specifically enrolled patients with skin of color (Fitzpatrick skin phototypes IV-VI).^20,21

ADmirable is an open-label phase 3B study of lebrikizumab specifically designed to include adolescents and adults with moderate to severe AD and more pigmented skin.²¹ After a follow-up of 16 weeks, nearly 70% of patients achieved at least 75% improvement in the Eczema Area and Severity Index (EASI)–75 compared with baseline across different skin types.²¹ At 16 weeks, 58.1% of patients reported
4-point or greater improvement in Pruritus Numeric Rating Scale (NRS). At week 24, 64.4% with baseline-assessed hyperpigmented areas showed reduced hyperpigmentation. Subgroup analyses confirmed efficacy across different racial groups, providing evidence for treatment effectiveness in traditionally underrepresented populations.²¹

DISCOVER, a phase 4 study of dupilumab in adolescents and adults with skin of color, included more than 80% African American participants.²⁰ After 24 weeks of treatment, more than 75% of patients achieved an EASI-75 response.²⁰ In addition, 65.6% of patients achieved a 3-point or higher improvement, and 52.7% achieved a 4-point or higher improvement in the Peak Pruritus NRS. Patients also reported a reduction in xerosis and experienced a reduction in postinflammatory hyperpigmentation severity, with 65% reporting minimized lesion intensity.²⁰ 

Data from both trials revealed that the medication safety profiles in patients with skin of color were comparable to those observed in the original pivotal phase 3 studies, confirming treatment safety across diverse populations.^20,21 The trial results can help provide clinicians with evidence-based confidence when recommending these therapies to their diverse patient populations and address the historical gap in representative clinical trial data.

Stakeholder Insights

“When we think about the demographics of clinical trials in general and across many disease states, including atopic dermatitis, there’s been this historical underrepresentation of populations with skin of color,” said Alexis. “If we want to answer important questions like, are there variations in safety and efficacy across diverse racial/ethnic populations? Are there differences in baseline characteristics such as comorbidities, certain biomarkers? Are there differences in the quality-of-life impact of the disease across the diverse spectrum of patients? Or, what’s the impact of postinflammatory hyperpigmentation and hypopigmentation on such patients, etc?… We are often limited by the data because…historically [they’ve] been limited, but thankfully…I think we’re at an inflection point,” he added.

Armstrong agreed. “This was very encouraging, I think, for our clinicians, as well as patients,…not only [knowing that] what we learn from phase 3 clinical trials can be generalized, but also very specifically now that we have data in this particular patient population,…we can really understand how the medication works in them.”

“Patients sometimes ask, ‘Well, has this worked in someone like me?’ ” said Mastro. “And what’s amazing about this now is that we have data that we can say, ‘Yes, you are represented with this therapy that I want to put you on. Here are the results of this therapy in people like you.’ And that is really powerful because it’s inclusion.”

He added that “getting them away from the use of topical corticosteroids being a crux of their therapy and moving them into a more diversified plan, knowing all of these sequelae that can come from the long-term use, that also plays into my conversations with my skin of color patients. So these trials are incredibly imperative to bridging the gap here between provider and patient.”

Makhinson noted, “From a [broader] standpoint, I think the access pathways to some of these treatments in underserved populations [are] so important to evaluate, right?… So really understanding what the barriers are there and what the options are for the patient based on their third party. And then secondarily, what’s the cost share? You may be able to get the ideal therapy for your patient, but if the cost burden to that patient is too high, what is the adherence going to look like? Will they stay on therapy? So, really considering all those barriers is so important in any population, but especially in a population such as this.”

“We opened up a clinic specifically for people [who] didn’t have access to us, whether because they were self-pay patients or just [that] we did not take their plans or…they were [receiving] Medicaid,” said Mastro. “And doing clinical trials in our site as well gives an opportunity [to] these patients who do not have access to these medications to then potentially get onto therapy. And that has been a game changer for us as well.”

“One of the things that we are doing and have also done in terms of increasing access to advanced systemic therapies for patients with inflammatory skin disease is through telehealth,” added Armstrong. “And we’ve actually done this study that’s [funded by the National Institutes of Health] that looked at outcomes of patients who were cared for in person vs via telehealth in atopic dermatitis. And what we found is that actually the clinical outcomes were quite equivalent. And the patients were a bit happier that they didn’t have to actually drive to us.”

Makhinson said, “As a large academic medical center in New York City, our motto is ‘We find a way.’ And for us, the 340B [Drug Pricing] Program…has really helped us to open up access to care for underserved patients.… We’ve used this around a variety of initiatives in a variety of disease states in the system. But dermatology has been one of the largest. And we’ve really seen some great achievements for patients [for whom] the cost share is restrictive for them to stay on therapy.”

Final Thoughts

“One of the key things I think about with atopic dermatitis and how we can do better with our patients is really emphasizing that this is a chronic immune-mediated disorder,” said Alexis. “Being able to get the patient off the cycle of flare management [and onto] a smooth longitudinal course.… We can do that now with our targeted therapies.”

“I will say that recognizing the heterogeneity in presentation, the heterogeneity in the immune-mediated drivers for our patients, is important,” said Armstrong. “So I’m very hopeful for the future when we’ll have even more treatment options for our patients.”

“It really takes a village for all of this,” stressed Mastro. “Everyone’s role in this together [is] to get someone on the appropriate therapy. But really, it goes to being a thoughtful practitioner and being thoughtful [when] we’re actually choosing our customized approach to our patients. And taking the time out in our day to meet someone at eye level, both literally and figuratively,” Mastro added.

Makhinson emphasized that “as the science improves, and more and more therapies come to market, [we must] not forget about the access and equity considerations for all these medications [and] ensure that all patients, regardless of social background or skin color, have access to the best-in-class therapies. And that the consolidated care team can really take that patient on the journey to optimize care and solutions for atopic dermatitis.” •

References

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10. Silverberg JI, Guttman-Yassky E, Thaçi D, et al; ADvocate1 and ADvocate2 Investigators. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091. doi:10.1056/NEJMoa2206714

11. Blauvelt A, Thyssen JP, Guttman-Yassky E, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023;188(6):740-748. doi:10.1093/bjd/ljad022

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13. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348. doi:10.1056/NEJMoa1610020

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16. Wongvibulsin S, Sutaria N, Kannan S, et al. Transcriptomic analysis of atopic dermatitis in African Americans is characterized by Th2/Th17-centered cutaneous immune activation. Sci Rep. 2021;11(1):11175. doi:10.1038/s41598-021-90105-w

17. Noda S, Suárez-Fariñas M, Ungar B, et al. The Asian atopic dermatitis phenotype combines features of atopic dermatitis and psoriasis with increased TH17 polarization. J Allergy Clin Immunol. 2015;136(5):1254-1264. doi:10.1016/j.jaci.2015.08.015

18. Silverberg JI, Gooderham M, Katoh N, et al. Combining treat-to-target principles and shared decision-making: international expert consensus-based recommendations with a novel concept for minimal disease activity criteria in atopic dermatitis. J Eur Acad Dermatol Venereol. 2024;38(11):2139-2148. doi:10.1111/jdv.20229

19. Amerio P, Ferrucci SM, Galluzzo M, et al. A multidisciplinary approach is beneficial in atopic dermatitis. Dermatol Ther (Heidelb). 2024;14(6):1443-1455. doi:10.1007/s13555-024-01185-1

20. Alexis A, Markowitz, O, Mayo T, et al. Dupilumab monotherapy in patients with skin of color and moderate-to-severe atopic dermatitis: results from a phase 4, open-label study. Presented at: 2025 Revolutionizing Atopic Dermatitis Conference; June 6-7 2025; Nashville, TN.

21. Alexis A, Moiin A, Waibel J, et al; ADmirable Investigators. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: results from the phase IIIb, open-label ADmirable study. Am J Clin Dermatol. 2025;26(5):803-817. doi:10.1007/s40257-025-00970-8