One year results of Phase III CHRONOS study of Dupixent (dupilumab)for treatment of atopic dermatitis- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. presented detailed results from the one-year Phase III CHRONOS study, which showed that patients receiving the investigational drug Dupixent (dupilumab) with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled moderate-to-severe atopic dermatitis (AD). The data will be presented as a late-breaking oral abstract at the Annual Meeting of the American Academy of Dermatology (AAD) taking place in Orlando, Florida. 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 Dupixent 300 mg weekly with TCS, Dupixent 300 mg every two weeks with TCS, or placebo with TCS.

Dupixent with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS. Sanofi and Regeneron Pharmaceuticals, Inc. presented detailed results from the one-year Phase III CHRONOS study, which showed that patients receiving the investigational drug Dupixent (dupilumab) with topical corticosteroids (TCS) achieved significantly improved measures of overall disease severity compared to TCS alone in adults with uncontrolled moderate-to-severe atopic dermatitis (AD). The data will be presented today as a late-breaking oral abstract at the Annual Meeting of the American Academy of Dermatology (AAD) taking place in Orlando, Florida. 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 Dupixent 300 mg weekly with TCS, Dupixent 300 mg every two weeks with TCS, or placebo with TCS.

Dupixent with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS. � At 16 weeks, 39 percent of patients who received either Dupixent 300 mg weekly with TCS or Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001). �At 16 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 69 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS (p less than 0.0001). �At 52 weeks, 40 percent of patients who received Dupixent 300 mg weekly with TCS, and 36 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001). �At 52 weeks, 64 percent of patients who received Dupixent 300 mg weekly with TCS, and 65 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75, compared to 22 percent with placebo with TCS (p less than 0.0001).

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