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.
| Autor: | Yang Y; Institute of Rheumatology and Immunology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing 100029, China., Xu J; The First Affiliated Hospital of Anhui Medical University, Hefei, China., Xu J; First Affiliated Hospital of Kunming Medical University, Kunming, China., Li X; Qilu Hospital of Shandong University, Jinan, China., Hu J; Jiangxi Pingxiang People's Hospital, Pingxiang, China., Li X; The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China., Zhang X; Guangdong General Hospital, Guangzhou, China., He D; Guanghua Hospital, Shanghai, China., Bao C; Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China., Li Z; First Affiliated Hospital of Bengbu Medical College, Bengbu, China., Wang G; China-Japan Friendship Hospital, Beijing, China., Zerbini CAF; Centro Paulista de Investigação Clinica e Serviços Médicos, Ipiranga, São Paulo, Brazil., Spindler AJ; Centro Medico Privado de Reumatologia, San Miguel de Tucumán, Argentina., Kannowski CL; Eli Lilly and Company, Indianapolis, IN, USA., Wu H; Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China., Ji F; Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China., Zhan L; Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China., Liu M; Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China., Li Z; Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People's Hospital, Xicheng District, Beijing, P.R. China. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | Therapeutic advances in musculoskeletal disease [Ther Adv Musculoskelet Dis] 2021 Apr 20; Vol. 13, pp. 1759720X211006964. Date of Electronic Publication: 2021 Apr 20 (Print Publication: 2021). |
| DOI: | 10.1177/1759720X211006964 |
| Abstrakt: | 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. Competing Interests: Conflict of interest statement: 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. (© The Author(s), 2021.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|