A Multinational, Prospective, Observational Study of the Effectiveness, Healthcare Resource Utilization and Costs in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic or Biologic Disease‑Modifying Therapies (RA-BE-REAL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BARICITINIB

  TOCILIZUMAB

  ADALIMUMAB

  GOLIMUMAB

  ETANERCEPT

  CERTOLIZUMAB PEGOL

  ABATACEPT

  INFLIXIMAB

  RITUXIMAB

  TOFACITINIB
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1840

Study design details

• Main study objective:
  To assess, within each cohort, the time to all-cause discontinuation of treatment, specifically discontinuation rates at 24 months, ie, the rate of patients who discontinued their initial baricitinib, tsDMARD, or bDMARD treatment.
• Outcomes:
  Treatment discontinuation rates at 24 months, Throughout the study: reasons for discontinuation, disease activity (Clinical Disease Activity Index, CDAI), physical functioning (Health Assessment Questionnaire-Disability Index, HAQ-DI), HRQOL (the European Quality of Life-5 Dimensions-5-Level, EQ-5D-5L), patients' assessment of pain (Pain VAS), Healthcare resource use (HRU) and associated costs, number of work days missed because of RA.
• Data analysis plan:
  All analyses will be by treatment cohort. The proportion of patients who discontinued treatment at 24 months including 95% CIs will be provided.Time to discontinuation will be estimated by Kaplan-Meier analysis. Descriptive statistics will be presented for the patient characteristics and based on the observed values of patients at each time point for CDAI, HAQ-DI, EQ-5D-5L, and the patient’s assessment of pain. For HRU, total quantity of resources used will be calculated as the sum of resources. Costs for the treatment during the 3 years after initiation of treatment will be calculated based on the HRU data, and using publicly available unit costs.Total direct medical costs during the 3 years will be calculated based on medication costs and HRU costs. For each cohort, the total direct medical cost will be described overall (all resources combined) and separately for each type of cost. Indirect costs (work days missed due to RA) will be calculated.