机构：[1]Peking University People's Hospital, Beijing, China.[2]Qilu Hospital of Shandong University, Jinan, China.[3]Guangdong General Hospital, Guangzhou, China.广东省人民医院[4]Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.[5]Jiangxi Pingxiang People's Hospital, Pingxiang, China.[6]The First Affiliated Hospital of Anhui Medical University, Hefei, China.[7]The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.[8]First Affiliated Hospital of Kunming Medical University, Kunming, China.昆明医科大学附属第一医院[9]GuangHua Hospital, Shanghai, China.[10]First Affiliated Hospital of Bengbu Medical College, Bengbu, China.[11]China-Japan Friendship Hospital, Beijing, China.[12]Eli Lilly and Company, Shanghai, China.[13]CEPIC-Centro Paulista de Investigação Clinica E Serviços Medicos, Ipiranga, São Paulo, Brazil.[14]Peking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com.
Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). This analysis aims to describe the efficacy and safety of baricitinib in Chinese RA patients with an inadequate response to methotrexate (MTX-IR), and to analyze the effects of baseline characteristics on the efficacy of baricitinib treatment.
In this 52-week, randomized, double-blind, placebo-controlled study, 231 Chinese patients with moderately to severely active RA who had MTX-IR were randomly assigned to placebo (n = 115) or baricitinib 4 mg once daily (n = 116). The primary endpoint was American College of Rheumatology 20% (ACR20) response at week 12. Other efficacy measures included ACR50, ACR70, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, patient's assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain were analyzed. Additionally, subgroup analyses were performed across baseline characteristics.
Statistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo. Most of the secondary objectives were met with statistically significant improvements. Efficacy of baricitinib was irrespective of patient demographics and baseline characteristics. Safety events were similar between the baricitinib and placebo groups.
The efficacy of baricitinib 4 mg in Chinese patients with moderately to severely active RA and prior MTX-IR was clinically significant compared to placebo regardless of baseline characteristics. Baricitinib was well tolerated with an acceptable safety profile during the full study period.
NCT02265705.
第一作者机构：[1]Peking University People's Hospital, Beijing, China.
推荐引用方式(GB/T 7714)：
Yang Yue,Li Xing-Fu,Zhang Xiao,et al.Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE.[J].RHEUMATOLOGY AND THERAPY.2020,7(4):851-866.doi:10.1007/s40744-020-00231-6.
APA：
Yang Yue,Li Xing-Fu,Zhang Xiao,Bao Chun-De,Hu Jian-Kang...&Li Zhan-Guo.(2020).Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE..RHEUMATOLOGY AND THERAPY,7,(4)
MLA：
Yang Yue,et al."Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE.".RHEUMATOLOGY AND THERAPY 7..4(2020):851-866
