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Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study(Open Access)

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收录情况： ◇ SCIE

作者：
Yang, Y[a,*1] * ; Xu, J[b] * ; Xu, J[c] * ; Li, X[d] ; Hu, J[e] ; Li, X[f] ; Zhang, X[g] ; He, D[h] ; Bao, C[i] ; Li, Z[j] ; Wang, G[k] ; Zerbini, C.A.F[l] ; Spindler, A.J[m] ; Kannowski, C.L[n] ; Wu, H[o] ; Ji, F[o] ; Zhan, L[o] ; Liu, M[o] ; Li, Z[p,*1,*2] ;
机构： [a]Institute of Rheumatology and Immunology, Peking University People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100029, China [b]The First Affiliated Hospital of Anhui Medical University, Hefei, China [c]First Affiliated Hospital of Kunming Medical University, Kunming, China [d]Qilu Hospital of Shandong University, Jinan, China [e]Jiangxi Pingxiang People’s Hospital, Pingxiang, China [f]The First Affiliated Hospital, USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China [g]Guangdong General Hospital, Guangzhou, China [h]Guanghua Hospital, Shanghai, China [i]Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China [j]First Affiliated Hospital of Bengbu Medical College, Bengbu, China [k]China-Japan Friendship Hospital, Beijing, China [l]Centro Paulista de Investigação Clinica e Serviços Médicos, Ipiranga, São Paulo, Brazil [m]Centro Medico Privado de Reumatologia, San Miguel de Tucumán, Argentina [n]Eli Lilly and Company, Indianapolis, IN, United States [o]Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China [p]Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People’s Hospital, Xicheng District, Beijing, China
出处：
DOI： 10.1177/1759720X211006964
ISSN：

关键词： baricitinib China inadequate response methotrexate patient-reported outcomes rheumatoid arthritis

摘要：
Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients (n = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. PROs assessed included Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity, patient’s assessment of pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), European Quality of Life-5 Dimensions-5 Level index scores and visual analogue scale, and measures collected in electronic patient daily diaries: duration of morning joint stiffness, Worst Tiredness, and Worst Joint Pain. Treatment comparisons were made with logistic regression and analysis of covariance models for categorical and continuous variables, respectively. Results: Statistically significant (p ⩽ 0.05) improvements in all PROs were observed in the baricitinib 4 mg group compared to placebo as early as week 1 to week 4; and were sustained to week 24. These improvements were maintained until week 52 for the baricitinib group. A significantly larger proportion of patients met or exceeded the minimum clinically important difference for HAQ-DI (⩾0.22) and FACIT-F (3.56) profiles in the baricitinib group. Conclusion: Baricitinib provided significant improvements in PROs compared to placebo to 52 weeks of treatment in patients with RA who had an inadequate response to MTX. Clinicaltrials.gov identifier: https://clinicaltrials.gov/ct2/show/NCT02265705; NCT02265705; RA-BALANCE. Registered 13 October 2014 © The Author(s), 2021.

基金：
Yue Yang, Jianhua Xu, Jian Xu, Xingfu Li, Jiankang Hu, Xiangpei Li, Xiao Zhang, Dongyi He, Zhijun Li, Alberto J Spindler and Zhanguo Li have nothing to disclose. Chunde Bao and Guochun Wang serve as advisory board members for baricitinib and have received consulting and/or speaking fees from Eli Lilly and Company (<$10,000 USD). Cristiano AF Zerbini reports grants from Eli Lilly and Company, Pfizer, Sanofi, and AbbVie outside the submitted work. Carol L Kannowski is a full-time employee of Eli Lilly and Company, Indianapolis, USA; reports personal fees from Eli Lilly and Company outside the submitted work; and is a stockholder in Eli Lilly and Company. The authors Lujing Zhan and Mengru Liu are full-time employees of Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China. The authors Hanjun Wu and Fei Ji are full-time employees of Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China and own stock in Eli Lilly and Company.
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外文
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出版当年[2022]版：
大类 | 3 区 医学
小类 | 3 区 风湿病学
最新[2023]版：
大类 | 2 区 医学
小类 | 3 区 风湿病学
JCR分区：
出版当年[2021]版：
Q3 RHEUMATOLOGY
最新[2023]版：
Q2 RHEUMATOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [a]Institute of Rheumatology and Immunology, Peking University People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100029, China [*1]Institute of Rheumatology and Immunology, Peking University People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing 100029, China
共同第一作者：
通讯作者：
通讯机构： [a]Institute of Rheumatology and Immunology, Peking University People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100029, China [p]Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People’s Hospital, Xicheng District, Beijing, China [*1]Institute of Rheumatology and Immunology, Peking University People’s Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing 100029, China [*2]Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People’s Hospital, Xicheng District, Beijing, P.R. China
推荐引用方式(GB/T 7714)：
Yang Y,Xu J,Xu J,et al.Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study(Open Access)[J].THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE.2021,13:doi:10.1177/1759720X211006964.
APA：
Yang, Y,Xu, J,Xu, J,Li, X,Hu, J...&Li, Z.(2021).Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study(Open Access).THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE,13,
MLA：
Yang, Y,et al."Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study(Open Access)".THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE 13.(2021)

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