Sanofi, Regeneron Tout Dupixent’s Effectiveness in Patients With Darker Skin Tone

Sanofi's Distribution Center in Quebec, Canada

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Atopic dermatitis manifests differently in patients with darker skin color, according to the companies, including subtler presentations and more severe and prolonged lesions compared to patients with lighter skin.

Sanofi and Regeneron beefed up the eczema efficacy profile of their blockbuster biologic Dupixent, which improved disease severity in patients with darker skin tones, according to Phase IV data.

Sunday’s data came from 120 patients with atopic dermatitis. Roughly 80% of the study participants were Black, while other patients were of Asian, American Indian, Arab or Central American descent, among other ethnicities.

Atopic dermatitis, a chronic condition characterized by underlying type 2 inflammation, can manifest differently in patients with darker skin, according to the Sunday release, resulting in worse disease burden, with more severe skin dryness, prolonged skin discoloration and hardened skin lesions. Inflammation can also be more difficult to detect in darker skin, appearing as more subtle changes in skin appearance, which in turn can lead to the underestimation of disease severity.

Sunday’s findings showed that Dupixent treatment every two weeks elicited at least a 75% improvement in overall disease severity in 76% of patients—with some participants experiencing these benefits after only two weeks. Dupixent likewise improved itch in more than half of treated patients and resulted in a 53% drop in post-inflammatory hyperpigmentation versus baseline.

Additionally, from 78% at baseline, the proportion of patients who were very or extremely bothered by dry skin dropped to 18% at the 24-week follow-up.

As for safety, Sanofi and Regeneron reported that Dupixent’s adverse events were “generally consistent” with what is known for the drug’s dermatology indications. Common side effects included headache, upper respiratory tract infections and eye inflammation. Dupixent is a monoclonal antibody that blocks activity in interleukin signaling and can be used for inflammation-related conditions.

Sunday’s data continue Dupixent’s winning streak in recent months. The biologic in April won the FDA’s blessing for chronic spontaneous urticaria (CSU)—becoming the first new targeted therapy for the skin disease in more than a decade.

This approval was a long time coming. The regulator in October 2023 rejected Dupixent for CSU, noting a lack of evidence of its efficacy. Sanofi and Regeneron regrouped and ran another study, which in September 2024 demonstrated a nearly 50% reduction in itch and urticaria activity in patients.

Aside from the CSU nod, Dupixent in September 2024 became the first FDA-approved biologic for chronic obstructive pulmonary disease. The therapy is also indicated for asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis. Dupixent earned more than $14 billion in 2024, growing 22% year-on-year.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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