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
单位：[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昆明医科大学附属第一医院[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广东省人民医院[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
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.
第一作者单位：[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[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.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".THERAPEUTIC ADVANCES in MUSCULOSKELETAL DISEASE 13.(2021)
