Sanofi and Regeneron Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of Dupixent® (dupilumab) in Moderate-to-Severe Atopic Dermatitis - Seite 2

• At 16 weeks, the mean percent improvement in EASI from baseline was 77 percent for patients who received Dupixent weekly with TCS and for patients who received Dupixent every two weeks with TCS, compared to 42 percent for patients receiving placebo with TCS (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 percent for patients who received Dupixent weekly with TCS and 58 percent for patients who received Dupixent every two weeks with TCS, compared to 29 percent for patients receiving placebo with TCS (p less than 0.0001).

At 16 weeks, 77 percent of patients who received Dupixent weekly with TCS or Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, compared to 37 percent of patients receiving placebo with TCS (p less than 0.0001).

At 16 weeks, 74 percent of patients who received Dupixent weekly with TCS and 81 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index (DLQI), compared to 43 percent of patients receiving placebo with TCS (p less than 0.0001). Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. 

At 52 weeks, the mean percent improvement in EASI from baseline was 80 percent for patients who received DUPIXENT weekly with TCS and 78 percent for patients who received DUPIXENT every two weeks with TCS, compared to 46 percent for patients receiving placebo with TCS (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 percent for patients who received DUPIXENT weekly with TCS and 56 percent for patients who received DUPIXENT every two weeks with TCS, compared to 27 percent for patients receiving placebo with TCS (p less than 0.0001).

At 52 weeks, 64 percent of patients who received Dupixent weekly with TCS and 76 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement in the severity of their AD, as measured by POEM, compared to 26 percent of patients receiving placebo with TCS (p less than 0.0001).

At 52 weeks, 63 percent of patients who received Dupixent weekly with TCS and 80 percent of patients who received Dupixent every two weeks with TCS achieved a >=4-point improvement their quality of life, as measured by the DLQI, compared to 30 percent of patients receiving placebo with TCS (p less than 0.0001).