单位:[1]Peking University People’s Hospital, Beijing, China[2]Jiangxi Pingxiang People’s Hospital, Pingxiang, China[3]The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China[4]Qilu Hospital of Shandong University, Jinan, China[5]The First Affiliated Hospital of Anhui Medical University, Hefei, China[6]Guangdong General Hospital, Guangzhou, China广东省人民医院[7]First Affiliated Hospital of Kunming Medical University, Kunming, China昆明医科大学附属第一医院[8]Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China[9]GuangHua Hospital, Shanghai, China[10]First Affiliated Hospital of Bengbu Medical College, Bengbu, China[11]China-Japan Friendship Hospital, Beijing, China[12]Xiangya Hospital of Central South University, Changsha, China[13]West China Hospital of Sichuan University, Chengdu, China四川大学华西医院[14]First Affiliated Hospital of Shantou University Medical College, Shantou, China[15]The Second Xiangya Hospital of Central South University, Changsha, China[16]Ningbo First Hospital, Ningbo, China[17]Zhuzhou Central Hospital, Zhuzhou, China[18]Zhongshan Hospital, Fudan University, Shanghai, China[19]Eli Lilly and Company, Shanghai, China
Introduction Baricitinib is an oral, selective inhibitor of Janus kinase which demonstrates clinical efficacy in patients with rheumatoid arthritis (RA). This report aims to analyze the onset time of baricitinib in Chinese patients with moderately to severely active RA who had an inadequate response to methotrexate. Methods This post hoc analysis evaluated clinical improvements of Chinese patients treated with baricitinib 4 mg once daily compared with placebo, based on data from a phase 3 study RA-BALANCE. Efficacy measures including American College of Rheumatology 20% (ACR20) response, ACR core set values, Disease Activity Score modified to include the 28 diarthrodial joint count (DAS28) using high-sensitivity C-reactive protein (hsCRP), DAS28-erythrocyte sedimentation rate, Simplified Disease Activity Index, Clinical Disease Activity Index, DAS28-hsCRP <= 3.2 response (low disease activity), and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were evaluated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24 (except for FACIT-F evaluated every 4 weeks). A logistic regression model and an analysis of covariance model were used to analyze treatment comparisons of categorical and continuous measures, respectively. Results Statistically significant (p <= 0.05) improvements were observed as early as week 1 or 2 for the baricitinib group compared to placebo in almost all main efficacy measures. For other outcomes including 66 swollen joint count, 68 tender joint count, FACIT-F, and DAS28-hsCRP <= 3.2 response rate, differences were evident (p <= 0.05) by week 4 in the baricitinib group compared with placebo. Significant improvements in all efficacy measures were sustained through 24 weeks. Conclusions Baricitinib demonstrated a rapid onset of efficacy on ACR20 response, ACR core set values, disease activity, and patient-reported outcome improvements in Chinese patients from RA-BALANCE.
基金:
Eli Lilly and CompanyEli Lilly
语种:
外文
被引次数:
WOS:
中科院(CAS)分区:
出版当年[2020]版:
大类|3 区医学
小类|3 区医学:研究与实验3 区药学
最新[2025]版:
大类|3 区医学
小类|2 区药学3 区医学:研究与实验
JCR分区:
出版当年[2019]版:
Q1PHARMACOLOGY & PHARMACYQ2MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q2MEDICINE, RESEARCH & EXPERIMENTALQ2PHARMACOLOGY & PHARMACY
第一作者单位:[1]Peking University People’s Hospital, Beijing, China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Zhan-Guo Li,Jian-Kang Hu,Xiang-Pei Li,et al.Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE[J].ADVANCES in THERAPY.2021,38(1):772-781.doi:10.1007/s12325-020-01572-y.
APA:
Zhan-Guo Li,Jian-Kang Hu,Xiang-Pei Li,Yue Yang,Xing-Fu Li...&Chen-Ge Li.(2021).Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE.ADVANCES in THERAPY,38,(1)
MLA:
Zhan-Guo Li,et al."Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE".ADVANCES in THERAPY 38..1(2021):772-781