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

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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. 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. 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. In patients with RA in Japan, male sex, older age, and prior X-ray examination were associated with increased MACE and malignancy risk.