Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ENBREL

Medical condition to be studied

Rheumatoid arthritis
Population studied

Short description of the study population

Elderly Patients with Rheumatoid Arthritis.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Rheumatoid arthritis patients

Estimated number of subjects

450000
Study design details

Main study objective

Both RA and older age are associated with a higher risk of comorbidities, and the appropriate treatment approach for older patients is unclear. We evaluated RWD to determine whether there is an association between ETN and select AEs in patients with RA, stratified by age. We hypothesized that there is no difference in risk of AEs between younger (aged ≤65 yr) and older (aged >65 yr) patients.

Outcomes

The primary outcome is that we determine that our hypothesis is correct that there is no difference in risk of certain AEs between younger (aged ≤65 yr) and older (aged >65 yr) patients using Enbrel. Determine the risk of CHF, SI, NMSC, and ILD in patients using Enbrel

Data analysis plan

Data from 2013 to 2018 were analyzed from the IBM Watson Health MarketScan Database which contains information on 104.5 million distinct patients, including 531,996 with RA. Patients were required to be enrolled ≥1 yr prior to RA diagnosis, the first exposure to ETN was after RA diagnosis and before the AE of interest: congestive heart failure (CHF), serious infection (SI), non-melanoma skin cancer (NMSC), or interstitial lung disease (ILD). Proportion of patients experiencing each AE was determined for patients ≤65 yr and >65 yr receiving and not receiving ETN. Differences were evaluated using Fisher’s Exact test. Logistic regression models assessed the interaction between ETN and age group. Propensity matching was performed, and logistic regression was applied using the propensity-score-matched cohort. Patients receiving and not receiving ETN were matched by age, age >65 yr, gender, and geographical region.