Regeneron Pharmaceuticals and Sanofi have released groundbreaking data from their Phase 4 DISCOVER trial, marking the first clinical study to specifically evaluate Dupixent® (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color. The 24-week, single-arm study enrolled 120 patients with darker skin tones and demonstrated significant therapeutic benefits across multiple disease parameters.
The trial’s primary endpoint showed that 76% achieved a ≥75% improvement in overall disease severity (EASI-75), with some patients experiencing improvements as early as two weeks. Secondary endpoints revealed that 53% achieved clinically meaningful improvement in itch (≥4-point reduction on the peak-pruritus numerical rating scale), addressing one of the most debilitating symptoms for patients with atopic dermatitis.
Particularly noteworthy were the improvements in hyperpigmentation, a condition that disproportionately affects patients with darker skin tones. Patients experienced a 53% reduction from baseline in post-inflammatory hyperpigmentation, dropping from 5.1 points (moderate/marked) to 2.4 points (mild). This finding addresses a critical unmet need, as traditional atopic dermatitis assessments often fail to capture the full disease burden in patients with skin of color.
Dr. Andrew Alexis, Professor of Clinical Dermatology at Weill Cornell Medicine, emphasized the study’s significance: “The results from the DISCOVER trial showed that Dupixent 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.” This clinical validation supports Dupixent’s use across diverse patient populations and helps address longstanding healthcare disparities in dermatological care.
The safety profile remained consistent with Dupixent’s established record across approved indications, with 42% experiencing adverse events, most commonly headache (3%), upper respiratory tract infection (2%), and conjunctivitis (3%). With over one million patients currently treated globally, Dupixent continues to expand its evidence base across multiple type 2 inflammatory conditions.
This data strengthens Dupixent’s position in the competitive atopic dermatitis market while addressing regulatory expectations for inclusive clinical development. The study’s findings could influence future dermatological assessment tools and treatment guidelines, particularly for underserved populations where disease severity may be systematically underestimated.
