Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis
Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis
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DOI：
10.1056/nejmoa1610020
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发表时间：
2016-12-15
影响因子：
158.5
通讯作者：
Ardeleanu, M.
中科院分区：
文献类型：
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作者：
Simpson, E. L.;Bieber, T.;Ardeleanu, M.
背景Dupilumab是一种抗白细胞介素-4受体α的人单克隆抗体，可抑制白细胞介素-4和白细胞介素-13的信号传导，这两种细胞因子可能是特应性或过敏性疾病（如特应性皮炎）的重要驱动因素。（SOLO 1和SOLO 2），我们招募了患有中度至重度特应性皮炎的成人，其疾病通过局部治疗控制不佳。患者以1：1：1的比例随机分配，接受皮下注射dupilumab（300 mg）或安慰剂每周一次，或相同剂量的dupilumab每隔一周与安慰剂交替，持续16周。主要结局是研究者总体评估评分为0或1（清除或几乎清除）且第16周评分较基线降低2分或以上的患者比例。我们在SOLO 1中招募了671例患者，在SOLO 2中招募了708例患者。在SOLO 1中，85例（38%）接受dupilumab每隔一周治疗的患者和83例（37%）接受dupilumab每周治疗的患者发生主要结局，而接受安慰剂的患者为23例（10%）（P
BACKGROUNDDupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis.METHODSIn two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1: 1: 1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo. The primary outcome was the proportion of patients who had both a score of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment and a reduction of 2 points or more in that score from baseline at week 16.RESULTSWe enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary outcome occurred in 85 patients (38%) who received dupilumab every other week and in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received placebo (P