The Safety of Ixekizumab in Chinese Adults with Moderate-to-Severe Plaque Psoriasis: Analyses from a Prospective, Single-Arm, Multicenter, 12-Week Observational Study

Ying Li, Lin Dang, Chengzhi Lv, Bingjiang Lin, Juan Tao, Nan Yu, Ya Deng, Huiping Wang, Xiaojing Kang, Hui Qin, Rong Chen, Jinnan Li, Yunsheng Liang (), Yanhua Liang () and Yuling Shi ()
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Ying Li: Tongji University School of Medicine
Lin Dang: Longgang Central Hospital of Shenzhen
Chengzhi Lv: Dalian Skin Disease Hospital
Bingjiang Lin: Ningbo First Hospital
Juan Tao: Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology
Nan Yu: General Hospital of Ningxia Medical Hospital
Ya Deng: The Second Hospital Affiliated to Chongqing Medical University
Huiping Wang: Tianjin Medical University General Hospital
Xiaojing Kang: People’s Hospital of Xinjiang Uygur Autonomous Region
Hui Qin: Tongji University School of Medicine
Rong Chen: Eli Lilly and Company
Jinnan Li: Eli Lilly and Company
Yunsheng Liang: Southern Medical University
Yanhua Liang: Southern Medical University
Yuling Shi: Tongji University School of Medicine

Drug Safety, 2024, vol. 47, issue 7, No 9, 719 pages

Abstract: Abstract Introduction Ixekizumab, a monoclonal antibody against interleukin-17A, is efficacious and well tolerated for the treatment of moderate-to-severe plaque psoriasis. However, there are limited data on the real-world safety of ixekizumab in Chinese patient populations. We performed an observational study of ixekizumab for the treatment of moderate-to-severe plaque psoriasis in routine clinical practice in China. Here we present a further safety analysis of this study. Methods In this prospective, observational, single-arm, multicenter, post-marketing safety study, adults (≥18 years) with moderate-to-severe plaque psoriasis receiving ixekizumab were enroled at dermatology departments in hospitals across China and prospectively followed for 12 weeks or until their last dose of ixekizumab. In this analysis, we evaluated adverse events (AEs) of special interest (AESIs) identified using MedDRA® search strategies. We also analyzed AEs and AESIs occurring in greater than ten patients in subgroups by age (

Date: 2024
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DOI: 10.1007/s40264-024-01427-3

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