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Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study

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Pubmed体系：
作者：
Xia Lixin[1] * ; Miao Guoying[2] ; Yang Xiumin[3] ; Li Yumei[4] ; Liang Yunsheng[5] ; Li Yanling[6] ; Li Linfeng[7] ; Ma Liping[8] ; Zhang Furen[9,10] ; Chen Rixin[11] ; Duan Xinsuo[12] ; Wang Lihua[13] ; Feng Yanyan[14] ; Li Ziyan[8] ; Lu Fengyan[15] ; Wang Jinyan[16] ; Guo Shuping[17] ; Zhao Jiawen[8] ; Wu Liming[18] ; Cui Yong[19] ; Li Shanshan[20] ; Ji Chao[21] ; Li Xiaodong[22] ; Lei Tiechi[23] ; Fan Juanli[24] ; Gao Xinghua[1] ;
机构： [1]Department of Dermatology, The First Hospital of China Medical University, Shenyang, China [2]Department of Dermatology, Affiliated Hospital of Hebei Engineering University, Handan, China [3]Department of Dermatology, Beijing Tongren Hospital, CMU, Beijing, China [4]Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, China [5]Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, China [6]Department of Dermatology, The Second Hospital of Hebei Medical University, Shijiazhuang, China [7]Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [8]Clinical Development Division, CSPC Megalith Biopharmaceutical Co., Ltd, Shijiazhuang, China [9]Department of Dermatology, Hospital for Skin Diseases, Shandong First Medical University, Jinan, China [10]Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences, Jinan, China [11]Department of Dermatology, Nanyang First People’s Hospital, Nanyang, China [12]Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, China [13]Department of Dermatology, Central Hospital Affiliated to Shandong First Medical University, Jinan, China [14]Department of Dermatology, Chengdu Second People’s Hospital, Chengdu, China [15]Department of Dermatology, Qujing No.1 Hospital, Qujing, China [16]Department of Dermatology, Ningbo No.2 Hospital, Ningbo, China [17]Department of Dermatology, First Hospital of Shanxi Medical University, Taiyuan, China [18]Department of Dermatology, Affiliated Hangzhou First People’s Hospital, School of Medicine, Westlake University, Hangzhou, China [19]Department of Dermatology, China-Japan Friendship Hospital, Beijing, China [20]Department of Dermatology, The First Bethune Hospital of Jilin University, Changchun, China [21]Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China [22]Department of Dermatology, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China [23]Department of Dermatology, Renmin Hospital of Wuhan University, Wuhan, China [24]Department of Dermatology, Yuncheng Central Hospital, Shanxi Medical University, Yuncheng, China.
出处：
DOI： 10.1016/j.jaad.2025.03.018
ISSN：

摘要：
SYSA1902 is a biosimilar of ustekinumab.Evaluate the efficacy and safety of SYSA1902 compared with reference ustekinumab in patients with moderate-to-severe plaque psoriasis.Eligible patients were randomized to receive SYSA1902 or ustekinumab (Stelara, Janssen) 45 mg subcutaneously at week 0, 4, 16, 28, and 40. The primary end point was the percentage improvement from baseline in psoriasis area and severity index (PASI) at week 12. Equivalence was verified if the 95% CI of difference was within ± 15%.A Total of 446 patients were assigned to SYSA1902 (n = 224) and ustekinumab groups (n = 222). At week 12, the mean percentage change from baseline in PASI was 86.4% in the SYSA1902 group and 84.7% in the ustekinumab group, with a difference of 1.68% (95% CI, -1.45 to 4.81), which fell within the equivalence margins. PASI 75 at week 12 was achieved by 185 (83.3%) of patients receiving SYSA1902 versus 172 (79.3%) receiving ustekinumab. Overall treatment-emergent adverse events rate was 89.3% and 85.6% in the SYSA1902 and ustekinumab groups. Most treatment-emergent adverse events were mild to moderate, with upper respiratory tract infection being the most common.Data limited to Chinese patients.SYSA1902 is equivalent to ustekinumab for the treatment of moderate-to-severe plaque psoriasis.Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.

基金：
CSPC Megalith Biopharmaceutial Co, Ltd.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 皮肤病学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 皮肤病学
第一作者：
第一作者机构： [1]Department of Dermatology, The First Hospital of China Medical University, Shenyang, China
通讯作者：
推荐引用方式(GB/T 7714)：
Xia Lixin,Miao Guoying,Yang Xiumin,et al.Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study[J].Journal Of The American Academy Of Dermatology.2025,doi:10.1016/j.jaad.2025.03.018.
APA：
Xia Lixin,Miao Guoying,Yang Xiumin,Li Yumei,Liang Yunsheng...&Gao Xinghua.(2025).Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study.Journal Of The American Academy Of Dermatology,,
MLA：
Xia Lixin,et al."Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: A multicenter, randomized, phase III study".Journal Of The American Academy Of Dermatology .(2025)

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