Big data analysis on treatment patterns and safety events in patients identified as rheumatoid arthritis according to International Statistical Classification of diseases and Related Health Problems (RA SE)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Rheumatoid arthritis

  Osteoarthritis

Population studied

• Short description of the study population:
  The subjects of this study shall select and analyze patients who meet the following inclusion and exclusion criteria among the recent five-year data provided by the Health Insurance Review and Assessment Service.; Inclusion criteria; Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:; 1. RA cohort group 1: Patients who have been diagnosed with rheumatoid arthritis by ICD code in the last four years and treated with bDMARDs or tsDMARD with or without csDMARDs treatment.; 2. RA cohort group 2: Patients who have been diagnosed with rheumatoid arthritis by ICD code in the last four years and treated with csDMARDs without bDMARDs or tsDMARD treatment.; 3. OA cohort group: Patients who have been diagnosed with osteoarthritis by ICD code in the last four years and used at least one of the osteoarthritis drugs for more than three months.; 4. Select RA cohort group 2 and OA cohort group with the same age and gender distribution as that of RA cohort group 1.; Exclusion criteria; Patients meeting any of the following criteria will not be included in the study:; 1. RA cohort group 1: Patients who have been diagnosed with rheumatoid arthritis by ICD code and treated with bDMARDs or tsDMARDs for the previous one year from the time of enrollment.; 2. RA cohort group 2: Patients who have been diagnosed with rheumatoid arthritis by ICD code and treated with csDMARDs, bDMARDs or tsDMARDs for the previous one year from the time of enrollment.; 3. OA cohort group: Patients who have been diagnosed with osteoarthritis by ICD code and used at least one of the osteoarthritis drugs for more than three months for the previous one year from the time of enrollment.; 4. All cohort groups: Persons who have developed Infection (pneumonia, herpes zoster, tuberculosis, cutaneous abscess, cellulitis), Malignancy for the previous one year from the time of enrollment.; 5. All cohort groups: Exclude if at least one month follow-up period is not met.; 6. Exclude clinic-grade from the classification of medical care institutions
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  16122

Study design details

• Main study objective:
  The objectives of this study are to identify the treatment patterns and safety events (Pneumonia, Herpes zoster, Tuberculosis, Malignancy) in patients identified as rheumatoid arthritis according to International Statistical Classification of diseases and Related Health Problems by using the representative secondary data in Korea.
• Outcomes:
  First, identify the treatment pattern of patients diagnosed with rheumatoid arthritis in the last four years. Second, identify the incidence of safety events and the scale of prevalence in patients diagnosed with rheumatoid arthritis in the last four years.
• Data analysis plan:
  The basic characteristics and basic clinical data of the subjects are summarized in a tabular format. Continuous data basically present mean, standard deviation, median, quartile ranges, minimum and maximum values, and categorical data present absolute and relative frequencies and corresponding percentages. To identify treatment patterns, the mean and standard deviation of treatment duration are calculated. Calculate the incidence of safety events and confidence intervals in patients diagnosed with the target diseases. The Kaplan-Meier method and a stratified Cox’s PH regression analysis are used to estimate the cumulative incidence (CI) of safety events and to compare the differences in the incidence of safety events among cohort groups.