| Title | 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 fro |
| Authors | Yang, Yue Xu, Jianhua Xu, Jian Li, Xingfu Hu, Jiankang Li, Xiangpei Zhang, Xiao He, Dongyi Bao, Chunde Li, Zhijun Wang, Guochun Zerbini, Cristiano A. F. Spindler, Alberto J. Kannowski, Carol L. Wu, Hanjun Ji, Fei Zhan, Lujing Liu, Mengru Li, Zhanguo |
| Affiliation | Peking Univ, Peoples Hosp, Inst Rheumatol & Immunol, 11 Xizhimen South St, Beijing 100029, Peoples R China Peking Univ, Peoples Hosp, Dept Rheumatol & Immun, Ctr Clin Immunol, Beijing, Peoples R China Peking Univ, Inst Rheumatol & Immunol, Med Sch, 11 Xizhimen South St, Beijing 100029, Peoples R China Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China Kunming Med Univ, Affiliated Hosp 1, Kunming, Yunnan, Peoples R China Shandong Univ, Qilu Hosp, Jinan, Peoples R China Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China Univ Sci & Technol China, Affiliated Hosp USTC 1, Anhui Prov Hosp, Div Life Sci & Med, Hefei, Peoples R China Guangdong Gen Hosp, Guangzhou, Peoples R China Guanghua Hosp, Shanghai, Peoples R China Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai, Peoples R China Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China China Japan Friendship Hosp, Beijing, Peoples R China Ctr Paulista Invest Clin & Serv Med, Ipiranga, SP, Brazil Ctr Med Privado Reumatol, San Miguel De Tucuman, Tucuman, Argentina Eli Lilly & Co, Indianapolis, IN 46285 USA Lilly Suzhou Pharmaceut Co Ltd, Shanghai, Peoples R China |
| Keywords | QUALITY-OF-LIFE MODIFYING ANTIRHEUMATIC DRUGS DISEASE-ACTIVITY CHINESE PATIENTS TOFACITINIB ADALIMUMAB COMBINATION BIOLOGICS EFFICACY BURDEN |
| Issue Date | Apr-2021 |
| Publisher | THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE |
| Abstract | 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. |
| URI | http://hdl.handle.net/20.500.11897/613002 |
| ISSN | 1759-720X |
| DOI | 10.1177/1759720X211006964 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 |
