Late-Breaking Data: Positive Outcomes in AD Patients with Skin of Color 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 for moderate to severe atopic dermatitis (AD).¹

Background

In phase 3 studies of dupilumab, subgroup analyses demonstrated a risk-benefit profile in patients with skin of color compared to the overall population.2 However, this 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 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 aged ≥12 years with Fitzpatrick skin types IV (43%), V (48%), and VI (9%). The mean age was 37.6 and 46.7% were female. Over 81% self-identified as Black/African American.

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

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

The primary endpoint was ≥75% 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 (X-AD) 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 improvement and 52.7% achieving a ≥4-point improvement.

According to the PHSS markers, a 52.9% decrease in physician-assessed disease severity of PIH 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. Over 80% of patients reported that they were either not bothered at all or only somewhat bothered by how dry their skin looked and felt. Conversely, nearly 50% were extremely bothered by their dryness when the study began.

Regarding safety, 41.9% of patients experienced ≥1 treatment-emergent adverse event. The most frequently reported ones included headache, eczema, upper respiratory tract infection, and conjunctivitis. Only 3 adverse effects 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 post-inflammatory hyperpigmentation and patient-reported xerosis. With this data, clinicians can be fully aware 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 (RAD) Conference; June 6-7, 2025; Nashville, TN.

2. Alexis AF, et al. J Drugs Dermatol. 2019;18:804-13.