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Dermatology Xagena

CHRONOS trial: Dupilumab in moderate-to-severe atopic dermatitis


The results from the one-year phase 3 CHRONOS study have shown that patients receiving the investigational drug Dupilumab ( Dupixent ) with topical corticosteroids ( TCS ) achieved significantly improved measures of overall disease severity compared to topical corticosteroids alone in adults with uncontrolled moderate-to-severe atopic dermatitis.

The data were presented at the Annual Meeting of the American Academy of Dermatology ( AAD ).

In the CHRONOS study, Dupilumab 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.

Patients were eligible for participation in the CHRONOS study if their disease was uncontrolled by topical medicines including corticosteroids with or without calcineurin inhibitors.
Patients were randomized to receive Dupilumab 300 mg weekly with topical corticosteroids, Dupilumab 300 mg every two weeks with topical corticosteroids, or placebo with topical corticosteroids.

Dupilumab with topical corticosteroids significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with topical corticosteroids.

As previously announced in June 2016, the primary endpoint results at week 16 and secondary endpoint 52-week results were the following:

At 16 weeks, 39% of patients who received either Dupilumab 300 mg weekly with topical corticosteroids or Dupilumab 300 mg every two weeks with topical corticosteroids achieved clear or almost clear skin ( IGA 0 or 1 ), compared to 12% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 16 weeks, 64% of patients who received Dupilumab 300 mg weekly with topical corticosteroids, and 69% of patients who received Dupilumab 300 mg every two weeks with topical corticosteroids achieved EASI-75, a 75% reduction on an index measuring eczema severity, compared to 23% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, 40% of patients who received Dupilumab 300 mg weekly with topical corticosteroids, and 36% of patients who received Dupilumab 300 mg every two weeks with topical corticosteroids achieved clear or almost clear skin ( IGA 0 or 1 ), compared to 12.5% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, 64% of patients who received Dupilumab 300 mg weekly with topical corticosteroids, and 65% of patients who received Dupilumab 300 mg every two weeks with topical corticosteroids achieved EASI-75, compared to 22% with placebo with topical corticosteroids ( p less than 0.0001 ).

New data have shown that:

At 16 weeks, the mean percent improvement in EASI from baseline was 77% for patients who received Dupilumab weekly with topical corticosteroids and for patients who received Dupilumab every two weeks with topical corticosteroids, compared to 42% for patients receiving placebo with topical corticosteroids ( p less than 0.0001).

At 16 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale ( NRS ), was 55% for patients who received Dupilumab weekly with topical corticosteroids and 58% for patients who received Dupilumab every two weeks with topical corticosteroids, compared to 29% for patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 16 weeks, 77% of patients who received Dupilumab weekly with topical corticosteroids or Dupilumab every two weeks with topical corticosteroids achieved a greater than or equal to 4-point improvement in the severity of their atopic dermatitis, as measured by the Patient Oriented Eczema Measure ( POEM ), a tool that quantifies the illness as experienced by the patients, compared to 37% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 16 weeks, 74% of patients who received Dupilumab weekly with topical corticosteroids and 81% of patients who received Dupilumab every two weeks with topical corticosteroids achieved a greater than or equal to 4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index ( DLQI ), compared to 43% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, the mean percent improvement in EASI ( Eczema Area and Severity Index ) from baseline was 80% for patients who received Dupilumab weekly with topical corticosteroids and 78% for patients who received Dupilumab every two weeks with topical corticosteroids, compared to 46% for patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the NRS, was 54% for patients who received Dupilumab weekly with topical corticosteroids and 56% for patients who received Dupilumab every two weeks with topical corticosteroids, compared to 27% for patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, 64% of patients who received Dupilumab weekly with topical corticosteroids and 76% of patients who received Dupilumab every two weeks with topical corticosteroids achieved a greater than or equal to 4-point improvement in the severity of their atopic dermatitis, as measured by POEM, compared to 26% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

At 52 weeks, 63% of patients who received Dupilumab weekly with topical corticosteroids and 80% of patients who received Dupilumab every two weeks with topical corticosteroids achieved a greater than or equal to 4-point improvement their quality of life, as measured by the DLQI, compared to 30% of patients receiving placebo with topical corticosteroids ( p less than 0.0001 ).

In the CHRONOS trial, 85% of patients who received Dupilumab weekly with topical corticosteroids and 86% of patients who received Dupilumab every two weeks with topical corticosteroids completed the 52 week treatment, compared to 67% of patients in the placebo group.
Patients who received Dupilumab with topical corticosteroids had higher rates of injection site reactions ( 19% Dupilumab weekly, 15% Dupilumab every two weeks and 8% topical corticosteroids alone ) and cases of conjunctivitis ( 19% Dupilumab weekly,14% Dupilumab every two weeks and 8% topical corticosteroids alone ). ( Xagena )

Source: Sanofi & Regeneron, 2017

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