OBJECTIVES: To assess baricitinib on patient-reported outcomes (PROs) in 
patients with moderately to severely active rheumatoid arthritis, who had 
insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors 
(TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
METHODS: In this double-blind phase III study, patients were randomised to 
once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the 
Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness 
Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index 
(HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's 
assessment of pain, duration of morning joint stiffness (MJS) and Work 
Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. 
Treatment comparisons were performed with logistic regression for categorical 
measures or analysis of covariance for continuous variables.
RESULTS: 527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; 
baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically 
significant improvements versus placebo in most PROs. Improvements were 
generally more rapid and of greater magnitude for patients receiving baricitinib 
4 mg than 2 mg and were maintained to week 24. At week 24, more 
baricitinib-treated patients versus placebo-treated patients reported normal 
physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F 
≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions 
in duration of MJS (p<0.01).
CONCLUSIONS: Baricitinib improved most PROs through 24 weeks compared with 
placebo in this study of treatment-refractory patients with previously 
inadequate responses to bDMARDs, including at least one TNFi. PRO results 
aligned with clinical efficacy data for baricitinib.
TRIAL REGISTRATION NUMBER: NCT01721044; Results.