Zhan-Guo Li1, Jian-Kang Hu2, Xiang-Pei Li3, Jing-Yang Li4, Chen-Ge Li5, Yue Yang6, Xing-Fu Li7, Jian-Hua Xu8, Xiao Zhang9, Jian Xu10, Chun-De Bao11, Dong-Yi He12, Zhi-Jun Li13, Guo-Chun Wang14, Xiao-Xia Zuo15, Yi Liu16, Zheng-Yu Xiao17, Jin-Wei Chen18, Xia-Fei Xin19, Lin-Di Jiang20, Meng-Ru Liu5, Fei Ji5. 1. Peking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com. 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. Zhuzhou Central Hospital, Zhuzhou, China. 5. Eli Lilly and Company, Shanghai, China. 6. Peking University People's Hospital, Beijing, China. 7. Qilu Hospital of Shandong University, Jinan, China. 8. The First Affiliated Hospital of Anhui Medical University, Hefei, China. 9. Guangdong General Hospital, Guangzhou, China. 10. First Affiliated Hospital of Kunming Medical University, Kunming, China. 11. Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China. 12. GuangHua Hospital, Shanghai, China. 13. First Affiliated Hospital of Bengbu Medical College, Bengbu, China. 14. China-Japan Friendship Hospital, Beijing, China. 15. Xiangya Hospital of Central South University, Changsha, China. 16. West China Hospital of Sichuan University, Chengdu, China. 17. First Affiliated Hospital of Shantou University Medical College, Shantou, China. 18. The Second Xiangya Hospital of Central South University, Changsha, China. 19. Ningbo First Hospital, Ningbo, China. 20. Zhongshan Hospital, Fudan University, Shanghai, China.
Abstract
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 tomethotrexate. 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02265705.
RCT Entities:
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. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02265705.
Authors: Josef S Smolen; Robert B M Landewé; Johannes W J Bijlsma; Gerd R Burmester; Maxime Dougados; Andreas Kerschbaumer; Iain B McInnes; Alexandre Sepriano; Ronald F van Vollenhoven; Maarten de Wit; Daniel Aletaha; Martin Aringer; John Askling; Alejandro Balsa; Maarten Boers; Alfons A den Broeder; Maya H Buch; Frank Buttgereit; Roberto Caporali; Mario Humberto Cardiel; Diederik De Cock; Catalin Codreanu; Maurizio Cutolo; Christopher John Edwards; Yvonne van Eijk-Hustings; Paul Emery; Axel Finckh; Laure Gossec; Jacques-Eric Gottenberg; Merete Lund Hetland; Tom W J Huizinga; Marios Koloumas; Zhanguo Li; Xavier Mariette; Ulf Müller-Ladner; Eduardo F Mysler; Jose A P da Silva; Gyula Poór; Janet E Pope; Andrea Rubbert-Roth; Adeline Ruyssen-Witrand; Kenneth G Saag; Anja Strangfeld; Tsutomu Takeuchi; Marieke Voshaar; René Westhovens; Désirée van der Heijde Journal: Ann Rheum Dis Date: 2020-01-22 Impact factor: 19.103