Dupixent Shows Promise for Atopic Dermatitis in Patients with Darker Skin Tones

Sanofi and Regeneron have announced positive Phase IV data for their blockbuster biologic Dupixent, demonstrating its efficacy in treating atopic dermatitis in patients with darker skin tones. The study results, released on Sunday, highlight the drug's potential to address a significant unmet need in dermatological care for diverse patient populations.

Study Highlights and Patient Demographics

The Phase IV trial involved 120 patients with atopic dermatitis, with approximately 80% of participants being Black. The remaining cohort included individuals of Asian, American Indian, Arab, and Central American descent, among other ethnicities. This diverse patient population is particularly noteworthy, as atopic dermatitis often manifests differently in patients with darker skin tones.

According to the companies, patients with darker skin color may experience more severe disease burden, including increased skin dryness, prolonged skin discoloration, and hardened skin lesions. Additionally, inflammation can be more challenging to detect in darker skin, potentially leading to underestimation of disease severity.

Efficacy and Safety Results

The study's findings were impressive, with 76% of patients achieving at least a 75% improvement in overall disease severity after treatment with Dupixent every two weeks. Some participants experienced these benefits as early as two weeks into treatment. Other notable outcomes include:

• Improved itch in more than half of treated patients
• A 53% reduction in post-inflammatory hyperpigmentation compared to baseline
• A significant decrease in the proportion of patients very or extremely bothered by dry skin, from 78% at baseline to 18% at the 24-week follow-up

Regarding safety, Sanofi and Regeneron reported that adverse events were generally consistent with Dupixent's known profile for dermatology indications. Common side effects included headache, upper respiratory tract infections, and eye inflammation.

Dupixent's Expanding Indications

This latest data adds to Dupixent's growing list of successes. The monoclonal antibody, which blocks interleukin signaling, has recently gained approval for several other indications:

• In April 2025, Dupixent received FDA approval for chronic spontaneous urticaria (CSU), becoming the first new targeted therapy for this skin condition in over a decade.
• September 2024 saw Dupixent become the first FDA-approved biologic for chronic obstructive pulmonary disease.

The drug is also indicated for asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. This broad range of applications has contributed to Dupixent's commercial success, with the therapy earning more than $14 billion in 2024, representing a 22% year-on-year growth.

As Sanofi and Regeneron continue to expand Dupixent's efficacy profile, particularly in diverse patient populations, the drug is poised to maintain its position as a key player in the treatment of inflammatory conditions across multiple therapeutic areas.