OBJECTIVES: Rheumatoid Arthritis (RA) is a chronic autoimmune disease, affecting over 2.9 million adults in Europe. A challenge for new RA therapies is demonstrating added value not only in efficacy and tolerability but also in terms of overall benefit for patients, carers, healthcare systems and society. The aims of this study were to document current unmet needs in RA in terms of patient-reported and economic burden and how such concepts may be assessed to capture the value of RA treatments. METHODS:  Articles were identified via searches in MEDLINE, EMBASE, EconLit, HEED, CRD databases and PSYCINFO using pre-defined search terms and limits. PRO measures were identified via the reviewed literature and the Patient-Reported Outcome and Quality of Life Database (PROQOLID) and were assessed in context of FDA guidelines. RESULTS: The literature search revealed 2,517 abstracts of which 123 articles were reviewed in full. RA symptoms significantly impact patient’s physical functioning, daily activities, and ability to work. Financial stability of patients and caregivers is affected and direct and indirect costs are incurred by healthcare systems. A conceptual model summarising patient-reported and economic burden of RA was developed to identify key measurement concepts which can demonstrate efficacy, tolerability, and wider impact of RA treatments. Relevant endpoint measures were identified; beyond traditional symptom reports the assessment of health-related quality of life, sleep, fatigue, daily activities, resource use and work productivity can provide data for regulatory, reimbursement, patient, and physician decision making. CONCLUSIONS: A patient-focused approach is increasingly advocated for underpinning individual and societal healthcare decisions. PRO measures, therefore, are essential for monitoring treatment outcomes among RA patients both in clinical trials and clinical practice. Where adequate instruments are included in clinical trials there exists opportunity to demonstrate the overall efficacy, tolerability, and value of a treatment to key stakeholders including regulatory and HTA bodies.