Sanofi/Regenerative new anti-inflammatory drug Dupixent treats adolescent endemic dermatitis (AD) Phase III clinically obtained:

French pharmaceutical giant Sanofi and partner Regeneron recently presented detailed data on a key Phase III clinical study of the anti-inflammatory drug Dupilumab for the treatment of adolescents (12-17 years old) in a key Phase III clinical study at the 27th European Society of Dermatology and Sexually Sensitive Diseases (EADV) conference in Paris. In the U.S., the FDA in 2016 granted Dupixent the right to treat breakthrough drugs for moderate to severe (12-17 years) and severe (6 months-11 years) AD patients with poor control of an external prescription drug. Based on the Phase III study data, Sanofi and Regeneratives have filed regulatory filings for the use of Dupixent for moderate to severe AD treatment in adolescents (12-17 years of age).
noted that the study was the first Phase III clinical study conducted in moderate to severe adolescent AD patients to assess the safety and effectiveity of a biotherapy. The study included 251 patients between the ages of 12 and 17 who were unable to adequately control their condition or were not suitable for local treatment using topical topical drugs. In the study, patients were randomly divided into three treatment groups for a 16-week control period: the first group received Dupixent injections of 200 mg or 300 mg every 2 weeks (based on weight, the initial dose was 400 mg or 600 mg), and the second group received Dupixent injections of 300 mg (initial dose 600 mg) every 4 weeks, and the third group received a placebo every 2 weeks. Outside the United States, the common primary endpoint was a 75% improvement in the area and severity index of eczema in week 16 treatment (EASY-75). In the United States, the main endpoint is the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear).
data show that in the 16th week of treatment, 41.5 per cent and 38 per cent of patients in the first and second groups achieved EASI-75, respectively, compared with 8 per cent in the placebo group, with statistically significant differences in data (p<0.001). In addition, 24 percent of patients treated with weight-based Dupixent every 2 weeks (200 mg or 300 mg) and 24 percent of patients treated with a fixed dose of Dupixent every 4 weeks (300 mg) reached the primary endpoint (IGA score 0 or 1), with a statistically significant difference in the placebo group (p<001).
secondary endpoints, in the 16th week of treatment, the first and second groups of EASI scores improved by an average of 66% and 65% relative to the baseline, the placebo group improved by 24% (p<0.001), and the first and second groups of itching numerical scales (NRS) scores improved by an average of 48% and 4% over the baseline. 5.5%, the placebo group improved by 19% (p<0.001), the first group and the second group had 49% and 39% of patients with peak itching numerical assessment scale (pp-NRS) scores to achieve at least 3 points improvement, and the placebo group rate was 9% (p<0.001). At the start of the study, patients reported an average itching score of 7.6. In addition, patients treated with Dupixent showed significant improvements in additional secondary endpoints, including EASI-50, improvement in the relative baseline score of SCORAD scores, quality of life assessed by the Children's Dermatological Quality of Life Index (CDLQI), and so on.
AD is a serious chronic inflammatory skin disease, mainly manifested in severe itching, obvious eczema-like changes and dry skin. The disease, which often occurs in infants and young children and lasts for life, can seriously affect the quality of life of patients due to chronic relapsed eczema-like rashes, severe itching, lack of sleep, dietary restrictions and psychosocial effects.
Dupixent is an all-human monoclonal antibody that specifically suppresses overactivation signals of two key proteins, IL-4 and IL-13. IL-4/IL-13 are two inflammatory factors that are thought to be key drivers of persistent intracted inflammation in AD.
Dupixent was approved at the end of March 2017, making it the world's first biologic agent to treat moderate to severe AD. To date, the drug has been approved by many countries and regions around the world for the treatment of adult patients with moderate to severe AD who do not have adequate control of the condition or are not suitable for these medications, including the United States, the European Union and Japan. Dupixent is a subdern injection drug that is given subsurficly every 2 weeks and can be used alone or in a combined way with an external corticosteroid. (Bio Valley)