Sanofi and Regeneron report positive Phase III data from atopic dermatitis trial

18th September 2017 (Last Updated August 7th, 2019 14:57)

Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase III clinical trial (CAFÉ) of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis (AD).

Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase III clinical trial (CAFÉ) of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis (AD).

Dupixent is a human monoclonal antibody being developed for simultaneous inhibition of overactive signalling of IL-4 and IL-13 cytokines.

The results showed that in combination with topical corticosteroids (TCS), Dupixent significantly improved overall disease severity, skin clearing, itching and quality of life.

CAFÉ evaluated 300mg of Dupixent weekly or every two weeks with TCS over a duration of 16 weeks in 325 European patients who could not be treated with cyclosporine A (CSA) or did not have medically advisable treatment.

The trial’s primary endpoint was a proportion of patients with a 75% or more improvement in the eczema area and severity index (EASI-75) score at 16 weeks from baseline.

"The safety profile in this study was consistent with three previous positive Dupixent Phase III studies in moderate-to-severe atopic dermatitis."

According to the results, 59% of subjects administered with weekly Dupixent and 63% with Dupixent every two weeks achieved EASI-75, compared to 30% who were given placebo with TCS.

University Medical Centre Utrecht National Expertise Centre for Atopic Dermatitis dermatologist Dr Marjolein De Bruin-Weller said: “In the CAFÉ study, Dupixent with topical corticosteroids significantly improved overall measures of disease severity, including lesions, itch, quality of life measures and symptoms of anxiety and depression in these patients. 

“The safety profile in this study was consistent with three previous positive Dupixent Phase III studies in moderate-to-severe atopic dermatitis.” 

With no new adverse events, the most frequent one observed during the trial was conjunctivitis.

The trial also assessed various secondary endpoints such as Dupixent effects on disease-related persistent itch, quality-of-life measures, and anxiety and depression symptoms at week 16.