Atopic dermatitis clinical trial : The jointly developed eczema drug, Dupixent (dupilumab) from Sanofi and Regeneron Pharmaceuticals has met the primary endpoints of a crucial one-year long phase 3 clinical trial in adult patients with uncontrolled moderate-to-severe atopic dermatitis (AD).
In the phase 3 eczema drug trial named as CHRONOS, the investigational medication Dupixent given along with topical corticosteroids (TCS) was compared with the monotherapeutic atopic dermatitis treatment using TCS.
The phase 3 results demonstrated that atopic dermatitis treatment with Dupixent and TCS had considerably eased the severity of the overall disease in comparison to TCS given alone in the patient group.
Andrew Blauvelt, M.D., President of Oregon Medical Research Center and principal investigator of the phase 3 eczema drug trial CHRONOS said: “These new results build upon previous positive Phase 3 monotherapy data. In the CHRONOS study, Dupixent used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to topical corticosteroids alone, which are commonly prescribed for moderate-to-severe atopic dermatitis.
“This study provides positive long-term data for Dupixent, which is important given atopic dermatitis is a chronic inflammatory disease. Additionally, the presentation highlights the critical role of IL-4 and IL-13 as drivers of this atopic condition.”
CHRONOS trial for Dupixent eczema drug featured patients whose diseases was not treatable by topic medications like corticosteroids given alone or in combination with calcineurin inhibitors.
The phase 3 eczema drug trial had patients randomized for the atopic dermatitis treatment, with one group given a weekly treatment with Dupixent 300 mg with TCS, another given two weeks of treatment with Dupixent 300 mg with TCS and the third group with placebo with TCS.
At 16 weeks and 52 weeks, Dupixent with TCS reduced the overall disease severity considerably in comparison to placebo with TCS.
The phase 3 trial showed that at 16 weeks, clear or almost clear skin was achieved in 39% of patients subjected to weekly atopic dermatitis treatment with Dupixent 300 mg with TCS or Dupixent 300 mg every two weeks with TCS against the 12% of patients receiving placebo with TCS.
When it comes to the breakdown, in the same period of 16 weeks, EASI-75 was achieved in 64% of patients subjected to weekly treatment of Dupixent 300mg with TCS and 69% of patients given two-week treatment with Dupixent 300mg with TCS. This was in comparison to 23% of patients given monotherapeutic atopic dermatitis treatment with placebo with TCS.
EASI-75, for the record means a 75% reduction on an index measuring severity of eczema.
Accepted for FDA priority review, the Dupixent Biologics License Application will be reviewed for a decision by the US regulator by March 29. Dupixent was previously granted the FDA Breakthrough Therapy designation for moderate to severe atopic dermatitis treatment in 2014. In Europe, European Medicines Agency (EMA) had accepted to review the Marketing Authorization Application of Dupixent in December last year.