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

• Main Authors: Yue Yang, Jianhua Xu, Jian Xu, Xingfu Li, Jiankang Hu, Xiangpei Li, Xiao Zhang, Dongyi He, Chunde Bao, Zhijun Li, Guochun Wang, Cristiano A. F. Zerbini, Alberto J. Spindler, Carol L. Kannowski, Hanjun Wu, Fei Ji, Lujing Zhan, Mengru Liu, Zhanguo Li
• Format: Article
• Language: English
• Published: SAGE Publishing 2021-04-01
• Series: Therapeutic Advances in Musculoskeletal Disease
• Online Access: https://doi.org/10.1177/1759720X211006964

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