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赛诺菲和再生元制药公司宣布其IL-4/IL-13单抗dupilumab长期治疗中重度特应性皮炎关键的Ⅲ期临床CHRONOS试验获阳性资料。本次美国皮肤科学会会议上新提供的Ⅲ期临床试验资料显示,16周时,dupilumab每周或每2周加皮质类固醇(TCS)组,湿疹面积和严重度指数较基线改善77%,安慰剂加TCS组为42%(P<0.01);瘙痒数值评定量表较基线改善58%和55%,安慰剂加TCS组为29%(P<0.01);患者湿疹测量较基线改善77%,安慰剂加TCS组为37%(P<0.01);皮肤病生活质量指数较基线改善74%,安慰剂加TCS组
Sanofi and Bio-Rad Laboratories Inc. announced that they have obtained positive data from the phase III clinical CHRONOS trial, the long-term treatment of moderate to severe atopic dermatitis with IL-4 / IL-13 monoclonal antibody dupilumab. The new Phase III clinical trial data presented at the meeting of the American Academy of Dermatology showed that at 16 weeks, the area of corticosteroids (TCS) and the eczema area and severity index were improved by 77% compared with the baseline for dupilumab weekly or every 2 weeks TCS group was 42% (P <0.01); pruritus numerical assessment scale improved 58% and 55% compared with baseline, placebo plus TCS group was 29% (P <0.01); patients with eczema measured 77% The placebo plus TCS group was 37% (P <0.01); the dermatologic quality of life index improved 74% from baseline; placebo plus TCS