Sanofi and Regeneron have shared positive results from a phase 4 study of their monoclonal antibody Dupixent (dupilumab) in atopic dermatitis patients with skin of colour.
Data from the open-label DISCOVER trial, which has been evaluating the drug in adults and adolescents aged 12 years and older with moderate-to-severe cases of the skin disorder, was presented at this year’s Revolutionizing Atopic Dermatitis Conference.
These are the first clinical study results for Dupixent in a large population of patients with darker skin tones, the companies outlined.
In DISCOVER, 120 patients (82% Black, 11% Asian, 2% American Indian/Alaska Native, 5% Arab, Central American or other) received Dupixent every two weeks using a weight-based dosing regimen.
At week 24, 76% of patients achieved at least a 75% improvement in overall disease severity, the trial’s primary endpoint, and 53% experienced clinically meaningful improvements in itch, with benefits seen in some patients from as early as week two.
Patients also achieved a 53% reduction from baseline in post-inflammatory hyperpigmentation, while only 18% reported being very or extremely bothered by their dry skin compared to 78% at baseline.
Affecting approximately 230 million people globally, atopic dermatitis is a chronic inflammatory skin disease characterised by persistent itch and recurrent skin lesions. The disease can present differently in people with darker skin tones, with these patients more likely to experience hardened skin lesions and severe skin dryness, itch, dyspigmentation and greater disease severity than those with lighter skin.
“Atopic dermatitis… has a high prevalence and quality of life impact on patients with skin of colour,” said Andrew Alexis, professor of clinical dermatology at Weill Cornell Medicine. “Unique clinical features like darker patches of hyperpigmentation versus redness typically seen on lighter skin may lead to less accurate diagnoses and underestimation of disease severity.”
“This data deepens the clinical understanding of atopic dermatitis within this underserved population, including use of newly validated scales,” Alexis added.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases. The drug is already approved for a range of indications, including certain cases of atopic dermatitis.