Tofacitinib With Methotrexate in Third-Line Treatment of Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Trial

2015 ◽  
Vol 67 (4) ◽  
pp. 475-483 ◽  
Author(s):  
Vibeke Strand ◽  
Gerd R. Burmester ◽  
Cristiano A. F. Zerbini ◽  
Charles A. Mebus ◽  
Samuel H. Zwillich ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Active Rheumatoid Arthritis ◽  
Phase Iii ◽  
Line Treatment ◽  
Phase Iii Trial ◽  
Active Rheumatoid Arthritis Patient ◽  
Patient Reported ◽  
Third Line ◽  
Third Line Treatment

scholarly journals 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

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110069
Author(s):  
Yue Yang ◽  
Jianhua Xu ◽  
Jian Xu ◽  
Xingfu Li ◽  
Jiankang Hu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Active Rheumatoid Arthritis ◽  
Phase Iii ◽  
Inadequate Response ◽  
Double Blind ◽  
Balance Study ◽  
Double Blind Placebo ◽  
Patient Reported ◽  
Phase Iii Study

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

scholarly journals Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis

RMD Open ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. e000410 ◽  
Author(s):  
Paul Emery ◽  
Ricardo Blanco ◽  
Jose Maldonado Cocco ◽  
Ying-Chou Chen ◽  
Carol L Gaich ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Refractory Rheumatoid Arthritis ◽  
Patient Reported ◽  
Phase Iii Study
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