Late-Breaking Data: Positive Outcomes in Patients With Skin of Color With AD Using Dupilumab

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Among the late-breaking data shared at the 2025 Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, Sanofi and Regeneron presented positive results from the DISCOVER trial, a phase 4 study of patients with skin of color being treated with dupilumab (Dupixent) for moderate to severe atopic dermatitis (AD).¹

Background

In earlier phase 3 studies of dupilumab, subgroup analyses demonstrated a risk-benefit profile in patients with skin of color compared with the overall population.² However, the sample size was limited. This vulnerable patient population is severely underrepresented in clinical research, despite the high disease prevalence, severity, and quality-of-life burden. The goal of the open-label, single-arm DISCOVER study (NCT05590585) was to further evaluate the efficacy and safety of dupilumab when used as a monotherapy in this patient group

Methods

Eligible participants in the analysis (n = 120) were 12 years or older with Fitzpatrick skin types IV (43%), V (48%), and VI (9%). The mean age was 37.6 years, and 46.7% were female; 81% self-identified as Black/African American.

At baseline, the average Eczema Area and Severity Index (EASI) score was 16 or higher, and the average Investigator’s Global Assessment (IGA) score was 3 or higher, with 31.7% having a score of 4. The mean body surface area (BSA) involved was approximately 10% or greater, and the weekly average of Peak Pruritus Numeric Rating Scale (PP-NRS) was 4 or higher. The average disease duration was 19.8 years.

Patients were treated with only dupilumab every 2 weeks. Those who weighed less than 60 kg received 200 mg, with a 400-mg loading dose on day 1. Those who weighed more than 60 kg received 300 mg, with a 600-mg loading dose on day 1.

The primary end point was a 75% or greater improvement from baseline in EASI (EASI-75). Investigators also evaluated PP-NRS, IGA, BSA, and any treatment-emergent adverse effects. The Post-Inflammatory Hyperpigmentation Severity Scale (PHSS) assessed overall disease severity, pigmentary intensity and area of lesions, degree of hypopigmentation, and other symptoms including erythema, burning, peeling, and dryness. Additionally, the Xerosis in Atopic Dermatitis tool was used, which is a newly developed instrument to help assess patient-reported outcomes on the feeling and appearance of dryness of the skin.

Results
After 24 weeks of dupilumab monotherapy, 76% of patients achieved an EASI-75 response. Positive changes in PP-NRS were also observed, with 65.6% achieving a 3-point or higher improvement, and 52.7% achieving a 4-point or higher improvement.

According to the PHSS markers, a 52.9% decrease in physician-assessed disease severity of postinflammatory hyperpigmentation was noted, with a moderate to marked score at baseline (5.1) to a mild score at week 24 (2.4). Nearly 80% of participants began the trial with moderate to severe hyperpigmented lesions. This decreased to 35%, with 65% of patients expressing that the intensity of their lesions had minimized to none, trace, or mild.

Xerosis NRS dropped from 8.2 at baseline to 4.8 at the conclusion of the trial. More than 80% of patients reported that they were either not bothered at all or only somewhat bothered by how dry their skin looked and felt. By comparison, when the study began, nearly 50% were extremely bothered by their dryness.

Regarding safety, 41.9% of patients experienced at least 1 treatment-emergent adverse event (AE). The most frequently reported AEs included headache, eczema, upper respiratory tract infection, and conjunctivitis. Only 3 AEs led to the discontinuation of dupilumab, and none of the treatment-emergent adverse events were serious.

Conclusion

Overall, the DISCOVER trial showed that dupilumab monotherapy improved signs and symptoms of moderate to severe AD in patients with skin of color. This included AD-related postinflammatory hyperpigmentation and patient-reported xerosis. These data give clinicians full awareness of dupilumab’s success rates, even in this patient population that is typically underrepresented in clinical research.

References

1. 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.

2. Alexis AF, Rendon M, Silverberg JI, et al. Efficacy of dupilumab in different racial subgroups of adults with moderate-to-severe atopic dermatitis in three randomized, placebo-controlled phase 3 trials. J Drugs Dermatol. 2019;18(8):804-813.