典型文献
Efficacy and Safety of Ixekizumab in Chinese Patients With Moderate-to-Severe Plaque Psoriasis: 60-Week Results From a Phase 3 Study
文献摘要：
Objective::Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A and is approved for treating moderate-to-severe psoriasis. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NCT03364309; registered December 6, 2017) evaluated the safety and efficacy of ixekizumab in Chinese patients with moderate-to-severe psoriasis.Methods::438 patients were randomized 2:2:1 to 80 mg ixekizumab every 2 weeks (IXE Q2W,
n = 176), 80 mg ixekizumab every 4 weeks (IXE Q4W,
n = 174), or placebo (
n = 88). Efficacy was assessed by evaluating the static Physician’s Global Assessment score of 0 or 1 (sPGA [0,1]) and Psoriasis Area and Severity Index (PASI) 75/90/100 responses, and nonresponder imputation was used for handling missing data. The safety profile was evaluated by assessing treatment emergent adverse events (AEs) and serious AEs.
Results::At week 12, the sPGA (0,1) response rates were 3.4%, 79.9%, and 86.4% in the placebo, IXE Q4W, and IXE Q2W groups, respectively. The PASI 75/90/100 response rates were 8.0%/2.3%/0.0%, 87.4%/75.9%/29.3%, and 93.8%/82.4%/33.0% in the placebo, IXE Q4W, and IXE Q2W groups, respectively. Ixekizumab led to rapid PASI 50 responses, as early as week 1, whereas PASI 75 and sPGA (0,1) responses were observed from week 2. sPGA (0,1) and sPGA (0) responses were maintained through week 60 in a higher proportion of patients receiving IXE Q4W
vs. placebo. The safety profile was consistent with previous studies of ixekizumab in psoriasis.
Conclusion::Ixekizumab showed a rapid onset of action and high efficacy that was maintained through 60 weeks and was well tolerated with no unexpected AEs, in Chinese patients with moderate-to-severe plaque psoriasis.
文献关键词：
China;efficacy;ixekizumab;psoriasis;rapid onset;safety
中图分类号：
作者姓名：
Li Xia;Zheng Jie;Pan Wei-Li;Zheng Min;Lu Yan;Li Fu-Qiu;Ding Yang-Feng;Zhang Jian-Zhong;Li Hong-Ying;Rui Wen-Long
作者机构：
Department of Dermatology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200025, China;Department of Dermatology, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang 314408, China;Department of Dermatology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China;Department of Dermatology, Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China;Department of Dermatology, The Second Hospital of Jilin University, Changchun, Jilin 130041, China;Department of Dermatology, Shanghai Skin Disease Hospital, Shanghai 130041, China;Department of Dermatology, Peking University People’s Hospital, Beijing 130041, China;China Drug Development and Medical Affairs Center, Eli Lilly and Company, Shanghai 200041, China
文献出处：
引用格式：
[1]Li Xia;Zheng Jie;Pan Wei-Li;Zheng Min;Lu Yan;Li Fu-Qiu;Ding Yang-Feng;Zhang Jian-Zhong;Li Hong-Ying;Rui Wen-Long-.Efficacy and Safety of Ixekizumab in Chinese Patients With Moderate-to-Severe Plaque Psoriasis: 60-Week Results From a Phase 3 Study)[J].国际皮肤性病学杂志（英文）,2022(04):181-190
A类：
Ixekizumab,NCT03364309,ixekizumab,IXE,Q2W,Q4W,nonresponder
B类：
Efficacy,Safety,Chinese,Patients,With,Moderate,Severe,Plaque,Psoriasis,Week,Results,From,Phase,Study,Objective,affinity,monoclonal,antibody,that,selectively,targets,interleukin,17A,approved,treating,moderate,severe,psoriasis,This,phase,multicenter,randomized,double,blind,placebo,controlled,trial,registered,December,evaluated,safety,efficacy,patients,Methods,were,every,weeks,was,assessed,by,evaluating,static,Physician,Global,Assessment,score,sPGA,Area,Severity,Index,PASI,responses,imputation,used,handling,missing,data,profile,assessing,treatment,emergent,adverse,events,AEs,serious,At,rates,groups,respectively,rapid,early,whereas,observed,from,maintained,through,higher,proportion,receiving,consistent,previous,studies,Conclusion,showed,onset,action,well,tolerated,unexpected,plaque,China
AB值：
0.406341
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