OBJECTIVES: Crohn’s disease (CD) is an inflammatory bowel disease affecting approximately 1.4 million people in the United States. The aims of this study were to document current unmet needs in CD in terms of patient-reported and economic burden; and how such concepts may be assessed to capture the overall benefit of new CD therapies for patients, healthcare systems and society. METHODS: Articles were identified in MEDLINE, EMBASE, EconLit, HEED, CRD databases and PSYCINFO using pre-defined search terms/limits. 561 abstracts were identified; and 31 full articles were reviewed. Direct and indirect costs of CD were extracted as were patient-relevant concepts (symptoms and impacts) to form a patient-relevant conceptual model. Patient-reported measures were identified in PROQOLID and were assessed in context of FDA guidance. RESULTS: CD symptoms manifest primarily as gastrointestinal disturbances including abdominal pain/cramping and diarrhoea. Fever, fatigue and weight loss are also prominent symptoms. These symptoms impact patients’ physical functioning, daily activities, emotional well-being, and ability to work. Seven patient-reported measures were reviewed in-depth; measures of HRQoL (IBDQ, SF-36, IBDQOL), occupational functioning (CPWDQ, WPAI:CD) and disease activity/symptoms (CDAI, CDAI-short, GSRS). Instruments to assess HRQoL and occupational functioning used concurrently with the CDAI may demonstrate the wider influence of treatment on other symptoms and patients’ lives. CD is associated with substantial direct costs, estimated at $18-$19,000 per-patient per-year in the US, and indirect costs, estimated at $7,260 per-patient per-year. Costs are especially high in sub-groups (e.g. presence of fistulas). CONCLUSIONS: The disease course of CD is characterised by remissions and relapses, thus lifetime humanistic and economic burden is substantial. This review highlights the need for disease-specific patient-reported measures that provide comprehensive assessment of relevant domains of disease activity/symptoms, HRQoL and occupational functioning. Further research into drivers of direct and indirect costs of CD is necessary to meet cost-effectiveness requirements.