Abstract
The treatment difference in the LS mean from baseline in the ISS7 was −0.80 (90% confidence interval [CI]: −1.64, 0.05), which lies within the predefined equivalence margin (±2.1) [Supplementary Table 2, http://links.lww.com/CM9/C413]. In the SYN008 and omalizumab groups, at week 12, the LS mean (SE) changes from baseline in the Dermatology Life Quality Index (DLQI) were −11.09 (0.37) and −11.00 (0.37), with an LS mean treatment difference of −0.08 (95% CI: −1.11, 0.95) [Supplementary Table 2, http://links.lww.com/CM9/C413]. During the 24-week study period, 118 (69.4%) patients in the SYN008 group and 120 (69.8%) patients in the omalizumab group experienced at least one treatment-emergent adverse event (TEAE). [5] The main limitation of this phase III study is the short total observation period of 24 weeks, with 12 weeks each for treatment and follow-up durations. [...]a long-term observational study in which more CSU patients and more data are available may be needed to further evaluate the efficacy and safety results of this study.
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1 Department of Dermatology, West China Hospital Sichuan University, Chengdu, Sichuan 610041, China
2 Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong 510091, China
3 Department of Dermatology, Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
4 Department of Dermatology, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong 510630, China
5 Department of Dermatology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China
6 Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350005, China
7 Department of Dermatology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, China
8 Shandong Province Dermatology Hospital, Weifang, Shandong 261042, China
9 Department of Dermatology, Wuxi Second People’s Hospital, Wuxi, Jiangsu 214002, China
10 Department of Dermatology, Peking University Third Hospital, Beijing 100191, China
11 Department of Dermatology, First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
12 Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing 400011, China
13 Department of Dermatology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050061, China
14 Department of Dermatology, Henan Provincial People’s Hospital, Zhengzhou, Henan 450003, China
15 Department of Dermatology, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China
16 Department of Dermatology, Wuhan Hospital of Traditional Chinese and Western Medicine/Wuhan No.1 Hospital, Wuhan, Hubei 430022, China
17 Department of Dermatology, The Southwest Hospital of AMU, Chongqing 400038, China
18 Institute of Dermatology, Chinese Academy of Medical Sciences, Beijing 100730, China
19 Department of Dermatology, Chinese PLA General Hospital, Beijing 100853, China
20 Department of Dermatology, Shengjing Hospital of China Medical University, Shenyang, Liaoning 110004, China
21 Department of Dermatology, Baogang Hospital of Inner Mongolia, Baotou, Inner Mongolia 014017, China
22 Department of Dermatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510120, China
23 Department of Dermatology, Affiliated Hospital of Chengde Medical University, Chengde, Hebei 067000, China
24 Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China
25 Department of Dermatology, The First Bethune Hospital of Jilin University, Changchun, Jilin 130031, China
26 Department of Dermatology, Qilu Hospital of Shandong University, Jinan,Shandong 266034, China
27 Department of Dermatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China
28 Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai 200443, China
29 Department of Dermatology, The Second Affiliated Hospital of Kunming Medical College, Kunming 650101, China
30 Department of Dermatology, The Second Norman Bethune Hospital of Jilin University, Changchun 130021, China
31 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Shijiazhuang, Hebei 050035, China
32 Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
33 Department of Dermatology, Peking University First Hospital, Beijing 100034, China