| Title | Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE |
| Authors | Yang, Yue Li, Xing-Fu Zhang, Xiao Bao, Chun-De Hu, Jian-Kang Xu, Jian-Hua Li, Xiang-Pei Xu, Jian He, Dong-Yi Li, Zhi-Jun Wang, Guo-Chun Wu, Han-Jun Ji, Fei Zhan, Lu-Jing Zerbini, Cristiano A. F. Li, Zhan-Guo |
| Affiliation | Peking Univ Peoples Hosp, Beijing, Peoples R China Shandong Univ, Qilu Hosp, Jinan, Peoples R China Guangdong Gen Hosp, Guangzhou, Peoples R China Shanghai Jiao Tong Univ, Renji Hosp, Sch Med, Shanghai, Peoples R China Jiangxi Pingxiang Peoples Hosp, Pingxiang, Peoples R China Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China Univ Sci & Technol China, Affiliated Hosp USTC 1, Div Life Sci & Med, Anhui Prov Hosp, Hefei, Peoples R China Kunming Med Univ, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China GuangHua Hosp, Shanghai, Peoples R China Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China China Japan Friendship Hosp, Beijing, Peoples R China Eli Lilly & Co, Shanghai, Peoples R China CEPIC Ctr Paulista Invest Clin E Serv Med, Ipiranga, SP, Brazil |
| Keywords | MODIFYING ANTIRHEUMATIC DRUGS INADEQUATE RESPONSE VENOUS THROMBOEMBOLISM REPORTED OUTCOMES AMERICAN-COLLEGE REMISSION PHASE-3 RISK RECOMMENDATIONS METHOTREXATE |
| Issue Date | Dec-2020 |
| Publisher | RHEUMATOLOGY AND THERAPY |
| Abstract | Introduction 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. Methods 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. Results 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. Conclusions 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. |
| URI | http://hdl.handle.net/20.500.11897/621543 |
| ISSN | 2198-6576 |
| DOI | 10.1007/s40744-020-00231-6 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
