Dupilumab improves atopic dermatitis severity in adolescents, adults with skin of color | Image Credit: © this_baker - © this_baker - stock.adobe.com.

Among a study population of adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) and skin of color, dupilumab (Dupixent; Regeneron Pharmaceuticals and Sanofi) demonstrated positive outcomes that improved overall disease severity, itch, and reduced post-inflammatory hyperpigmentation, according to an announcement from Regeneron. These data were announced at the 2025 Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, on June 7.¹

Via the DISCOVER phase 4, single-arm, open-label trial, the data are the first clinical trial results for dupilumab in a large population of patients with darker skin tones. The trial featured 120 patients with AD and skin of color. Of the participants, 82% were Black, 11% Asian, 2% American Indian/Alaska Native, and 5% Arab, Central American, or other. Individuals were treated every 2 weeks with dupilumab using a weight-based dosing regimen.

Results at 24 weeks revealed that 76% of individuals achieved a 75% or more improvement in overall disease severity (EASI-75), the trial's primary endpoint. In some patients, results were observed as early as 2 weeks. Additionally, 53% of participants achieved a clinically meaningful improvement in itch, defined as a 4-point or more reduction on the peak-pruritus numerical rating scale. Similar to EASI-75 results, some patients achieved itch improvement as early as 2 weeks.

Overall, patients experienced a 53% reduction from baseline in post-inflammatory hyperpigmentation, decreasing from 5.1 points to 2.4 points (moderate/marked to mild). Score changes were based on the clinician-reported Post-Inflammatory Hyperpigmentation Severity Scale (0-8).^1,2

Compared to 78% of individuals who were "very or extremely bothered" by dry skin at baseline, 18% were bothered at 24 weeks, based on patient reporting, stated Regeneron.

"Atopic dermatitis, a chronic disease with underlying type 2 inflammation, has a high prevalence and quality of life impact on patients with skin of color," said Andrew Alexis, MD, MPH, in a statement. Alexis is a professor of Clinical Dermatology at Weill Cornell Medicine. "The results from the DISCOVER trial showed that [dupilumab] patients with atopic dermatitis and darker skin not only experienced reduced disease severity and itch but also saw improvements in areas of particular concern, including dyspigmentation and dry skin," Alexis added. "These data deepen the clinical understanding of atopic dermatitis within this underserved population, including use of newly validated scales.”

Dupilumab adolescent indications approved in the United States

In the United States, dupilumab is approved for the following indications, according to Regeneron and Sanofi^1,2:

• "To treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. [Dupilumab] can be used with or without topical corticosteroids. It is not known if [Dupilumab] is safe and effective in children with atopic dermatitis under 6 months of age.
• With other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in adults and children 6 years of age and older, whose asthma is not controlled with their current asthma medicines. [Dupilumab] helps prevent severe asthma attacks (exacerbations) and can improve your breathing. [Dupilumab] may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if [Dupilumab] is safe and effective in children with asthma under 6 years of age.
• With other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if [Dupilumab] is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age.
• To treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE) who weigh at least 33 pounds (15 kg). It is not known if [Dupilumab] is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg).
• To treat adults with prurigo nodularis (PN). It is not known if [Dupilumab] is safe and effective in children with prurigo nodularis under 18 years of age.
• With other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). [Dupilumab] is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if [Dupilumab] is safe and effective in children with chronic obstructive pulmonary disease under 18 years of age.
• To treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if [Dupilumab] is safe and effective in children with chronic spontaneous urticaria under 12 years of age, or who weigh less than 66 pounds (30 kg)."

References:

1. Dupixent (dupilumab) data at Revolutionizing Atopic Dermatitis (RAD) Conference reinforce use in atopic dermatitis patients with skin of color. Regeneron. Press release. June 7, 2025. Accessed June 9, 2025. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-revolutionizing-atopic-dermatitis-rad

2. Media Update: RAD: Dupixent data reinforce use in atopic dermatitis patients with skin of color. Sanofi. Press release. June 7, 2025. Accessed June 9, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-07-22-30-00-3095548