Risk Factors Associated With Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis in a Real‐World Setting in Japan

AIM: To identify risk factors associated with major adverse cardiovascular events (MACE) and malignancies in patients with rheumatoid arthritis (RA) using real-world data from Japan. METHODS: This cohort study used the Real World Data database of medical institutions in Japan. Eligible patients (January 2013-December 2021) had ≥ 1 RA diagnosis, were aged ≥ 18 years, prescribed ≥ 1 antirheumatic drug, had no psoriasis diagnosis, and had a record postindex. Patients had no myocardial infarction/stroke ≤ 31 days (MACE cohort) or malignancy < 1 year (malignancy cohort) before index. Cohorts were determined by incidence of initial MACE or malignancy. Known/exploratory variables were selected using Cox regression models. RESULTS: Across MACE (n = 16 012) and malignancy (n = 14 545) cohorts, most patients were female and aged ≥ 65 years. Overall, 214 MACE per 43964.7 patient-years (incidence rate 0.49 per 100 patient-years) and 315 malignancies per 40251.6 patient-years (incidence rate 0.78 per 100 patient-years) occurred. Male sex, older age (≥ 65 years), hypertension, renal disease, cerebrovascular disease, and prior X-ray examination were significantly associated with increased MACE risk. Male sex, older age (≥ 50 years), nonsteroidal anti-inflammatory drug use, emphysema, serious infection, malignancy history, and prior X-ray examination were significantly associated with increased malignancy risk. Conversely, glucocorticoid use and fracture diagnosis were significantly associated with reduced malignancy risk. CONCLUSION: In patients with RA in Japan, male sex, older age, and prior X-ray examination were associated with increased MACE and malignancy risk.