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

作者全名：Li, Ying; Dang, Lin; Lv, Chengzhi; Lin, Bingjiang; Tao, Juan; Yu, Nan; Deng, Ya; Wang, Huiping; Kang, Xiaojing; Qin, Hui; Chen, Rong; Li, Jinnan; Liang, Yunsheng; Liang, Yanhua; Shi, Yuling

作者地址：[Li, Ying; Qin, Hui; Shi, Yuling] Tongji Univ, Shanghai Skin Dis Hosp, Sch Med, Dept Dermatol, Shanghai 200443, Peoples R China; [Dang, Lin] Longgang Cent Hosp Shenzhen, Dept Dermatol, Shenzhen, Guangdong, Peoples R China; [Lv, Chengzhi] Dalian Skin Dis Hosp, Dept Dermatol, Dalian, Liaoning, Peoples R China; [Lin, Bingjiang] Ningbo First Hosp, Dept Dermatol, Ningbo, Zhejiang, Peoples R China; [Tao, Juan] Huazhong Univ Sci & Technol, Wuhan Union Hosp, Tongji Med Coll, Dept Dermatol, Wuhan, Hubei, Peoples R China; [Yu, Nan] Gen Hosp Ningxia Med Hosp, Dept Dermatol, Yinchuan, Ningxia, Peoples R China; [Deng, Ya] Chongqing Med Univ, Hosp 2, Dept Dermatol, Chongqing, Peoples R China; [Wang, Huiping] Tianjin Med Univ, Gen Hosp, Dept Dermatol, Tianjin, Peoples R China; [Kang, Xiaojing] Peoples Hosp Xinjiang Uygur Autonomous Reg, Dept Dermatol, Urumqi, Xinjiang, Peoples R China; [Chen, Rong; Li, Jinnan] Eli Lilly & Co, Shanghai, Peoples R China; [Liang, Yunsheng] Southern Med Univ, Dermatol Hosp, Dept Dermatol, Guangzhou, Guangdong, Peoples R China; [Liang, Yanhua] Southern Med Univ, Shenzhen Hosp, Dept Dermatol Cosmetol & Venereol, Shenzhen, Guangdong, Peoples R China

通信作者：Shi, YL (通讯作者)，Tongji Univ, Shanghai Skin Dis Hosp, Sch Med, Dept Dermatol, Shanghai 200443, Peoples R China.; Liang, YS (通讯作者)，Southern Med Univ, Dermatol Hosp, Dept Dermatol, Guangzhou, Guangdong, Peoples R China.; Liang, YH (通讯作者)，Southern Med Univ, Shenzhen Hosp, Dept Dermatol Cosmetol & Venereol, Shenzhen, Guangdong, Peoples R China.

来源：DRUG SAFETY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001211480300002

JCR分区：Q1

影响因子：4

年份：2024

卷号：47

期号：7

开始页：711

结束页：719

文献类型：Article

关键词：　

摘要：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 (R) search strategies. We also analyzed AEs and AESIs occurring in greater than ten patients in subgroups by age (< 65/>= 65 years), sex, body weight (< 60/60 kg to < 80/>= 80 kg), renal impairment, hepatic impairment, history of tuberculosis, history of HBV infection, recent or active infection, history of allergic reaction/hypersensitivity, and number (0-1/2-4/5-7) of ixekizumab 80 mg injections after baseline until day 105. Results This analysis included 663/666 patients enrolled in the primary study. At least one AESI was reported in 224 (33.8%) patients and considered related to ixekizumab in 181 (27.3%); the most common were injection site reactions (n = 131, 19.8%), infections (n = 80, 12.1%), and allergic reactions/hypersensitivity events (n = 59, 8.9%). The proportion of patients with >= 1 AE was higher for females versus males (99/186, 53.2% versus 184/477, 38.6%, p = 0.0006). The proportion of patients with >= 1 AE increased with the number of ixekizumab injections after baseline [61/188 (32.4%) for zero to one injection, 151/338 (44.7%) for two to four injections, and 61/106 (57.5%) for five to seven injections; p = 0.0001]. Conclusions In this real-world study, ixekizumab was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis, with no difference in safety across most patient subgroups.

基金机构：Eli Lilly and Company; National Natural Science Foundation of China [82073429, 82273510, 82203913, 82003334]; Innovation Program of Shanghai Municipal Education Commission [2019-01-07-00-07-E00046]; Clinical Research Plan of SHDC [SHDC2020CR1014B]; Program of Shanghai Academic Research Leader [20XD1403300]

基金资助正文：The authors thank all patients who participated in this study. The authors thank Jake Burrell (PhD, Rude Health Consulting) for editorial support (funded by Eli Lilly and Company). The authors would like to thank Weigang Zhang (PhD, Eli Lilly and Company), Yu Dong (PhD, Eli Lilly and Company), Jiao Yu (MD, Eli Lilly and Company), and Xiao Ma (PhD, Eli Lilly and Company) for review and critical suggestions for improvement. The authors also thank the grants from the National Natural Science Foundation of China (no. 82073429, 82273510, 82203913, and 82003334), the Innovation Program of Shanghai Municipal Education Commission (no.2019-01-07-00-07-E00046), the Clinical Research Plan of SHDC (no. SHDC2020CR1014B), and the Program of Shanghai Academic Research Leader (no. 20XD1403300).