Clinical Trials

Date: 2017-09-16

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the European Academy of Dermatology and Venerology (EADV) Congress

Company: Sanofi (France) Regeneron Pharmaceuticals (USA - NY)

Product: dupilumab

Action mechanism:

• monoclonal antibody. Dupilumab is a fully-human monoclonal antibody directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of the Th2 (Type 2 helper T-cell) immune response, which is believed to be a critical pathway in allergic inflammation. Dupilumab was created using Regeneron's pioneering VelocImmune® technology and is being co-developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyps.

Disease: moderate-to-severe atopic dermatitis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country:

Trial details:

Latest news:

• • On September 16, 2017,  Sanofi and Regeneron Pharmaceuticals announced positive results from the Phase 3 CAFÉ study of Dupixent® (dupilumab) in adults with moderate-to-severe atopic dermatitis who are inadequately controlled with or intolerant to cyclosporine A, or when this treatment is medically inadvisable. These results are being presented at the European Academy of Dermatology and Venerology (EADV) Congress in Geneva, Switzerland.
• In the study, dupilumab with topical corticosteroids significantly improved measures of overall disease severity, skin clearing, itching, and patient reported quality of life measures.
• The primary endpoint of the study was the proportion of patients that achieved a 75 percent or greater improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks from baseline. Fifty-nine percent of patients who received dupilumab weekly with topical corticosteroids, and 63 percent of patients who received dupilumab every two weeks with topical corticosteroids achieved EASI-75, compared to 30 percent of those patients who received placebo with topical corticosteroids (p less than 0.0001).
• The mean percent change improvement in EASI from baseline at 16 weeks (a secondary endpoint) was 78 percent and 80 percent for patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 47 percent for those who received placebo plus topical corticosteroids (p less than 0.0001).
• Other secondary endpoints of the study included measures of the impact of dupilumab on the persistent itch caused by the disease, quality of life measures, and symptoms of anxiety and depression. The results for these secondary endpoints at 16 weeks include:
• The mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the pruritus Numerical Rating Scale (NRS), was 52 percent and 54 percent in patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 25 percent for those who received placebo plus topical corticosteroids (p less than 0.0001). The proportion of patients with a greater than or equal to four-point improvement from baseline in aspects of patient quality of life, as measured by the Dermatology Life Quality Index (DLQI), was 78 percent and 88 percent in patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 44 percent of those who received placebo plus topical corticosteroids. The proportion of patients with a greater than or equal to four-point improvement from baseline 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, was 76 percent and 83 percent in patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 42 percent for those who received placebo plus topical corticosteroids(p less than 0.0001).
• No new adverse events were reported in the study. The proportion of patients reporting an adverse event was similar among the treatment arms. Conjunctivitis was more frequent in patients who received dupilumab with topical corticosteroids, with 16 percent and 28 percent reported in patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 11 percent for patients who received placebo with topical corticosteroids. Injection site reactions were reported in 11 percent and 4 percent among patients who received dupilumab with topical corticosteroids weekly or every two weeks, respectively, compared to 5 percent for patients who received placebo with topical corticosteroids. Skin infections were reported in 4 percent and 2 percent among patients who received dupilumab weekly or every two weeks with topical corticosteroids, respectively, compared to 8 percent for patients who received placebo with topical corticosteroids.
• A total of 325 patients in Europe were randomized into three treatment groups in the 16-week study to receive either Dupixent 300 mg weekly with topical corticosteroids, Dupixent 300 mg every two weeks with topical corticosteroids or placebo with topical corticosteroids.

Is general: Yes