Rheumatoid arthritis (RA) is described by inflammatory activity, and joint damage that results in disability, pain, limits in physical function and other impairments noted to patients. Assessed results can be enhanced with adequate therapy. Decreases in bodily function may be a consequence of both disease activity and irreversible, progressive joint damage.

Patient-reported outcome (PRO) measures include health-related quality of life (HRQOL), physical function, disability, fatigue, sleep, mental health status, work productivity and work activity impairment.

To evaluate the effectiveness of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX). In this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs include the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, 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 and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA). And evaluations collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was in week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables. When compared with placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. The statistically significant increase in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p≤0.05).

Baricitinib provided a significantly more significant improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. The advance was maintained to the end of the study (week 52).