Effect of introducing biologics to patients with rheumatoid arthritis on the risk of venous thromboembolism: a nationwide cohort study

Chao-Ping Chen,Wen-Yu Chou,Wen-Chen Tsai,Pei-Tseng Kung

doi:10.1038/s41598-021-96508-z

Abstract

In the United States, 100,000–300,000 patients die from venous thromboembolism (VTE) each year, with more than 500,000 people related hospitalizations. While in Europe, 500,000 people die from VTE each year. Patients with rheumatoid arthritis are at increased risk of VTE. The use of biologics in patients with rheumatoid arthritis may be associated with an increased risk of VTE. We identified all patients who had been newly approved for Catastrophic Illness Card of rheumatoid arthritis extracted the claims data from the National Health Insurance research database and Registry for Catastrophic Illness Patient Database from 2003 to 2016. VTE was defined as the presence of inpatient VTE diagnostic codes (including DVT or PE) according to the discharge diagnosis protocol. An analysis of VTE variables indicated that the incidence of VTE in the biologic group (14.33/10,000 person-years) was higher than that in the conventional drug group (12.61/10,000 person-years). As assessed by the Cox proportional hazards model, the relative HR for VTE in the biologic group (HR: 1.11; 95% CI 0.79–1.55) versus that in the conventional drug group did not reach a significant difference. In conclusion, this study found no significant differences in risk were observed between the use of conventional DMARDs and biologics.

Highlights

In the United States, 100,000–300,000 patients die from venous thromboembolism (VTE) each year, with more than 500,000 people related hospitalizations
The study identified 35,409 patients with newly approved for Catastrophic Illness Card of rheumatoid arthritis using disease-modifying anti-rheumatic drugs (DMARDs) from 2003 to 2016, and excluded: (1) 3,340 patients who had a total hip replacement or total knee replacement; (2) 123 patients who had VTE and Pulmonary embolism (PE) prior to the index date; (3) 2060 patients who had other major injuries prior to the index date; (4) 692 patients who were under 18 years of age; and (5) 321 patients with incomplete data. (Fig. 1)
The findings presented at the 2013 meeting sponsored by the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP) showed that patients with rheumatoid arthritis were at an increased risk of VTE within 180 days of the initiation of biologics (HR: 2.48, 95% confidence interval (CI) 1.14–5.40)

Summary

Introduction

In the United States, 100,000–300,000 patients die from venous thromboembolism (VTE) each year, with more than 500,000 people related hospitalizations. Patients with rheumatoid arthritis are at increased risk of VTE. The use of biologics in patients with rheumatoid arthritis may be associated with an increased risk of VTE. According to the study by the American College of Rheumatology (ACR) and the Association of Rheumatology Health Professionals (ARHP) presented at their 2013 meeting, the initiation of biologic drugs in patients with RA was associated with a 2.5-fold increased risk of VTE in the first 180 days[16].

Methods

Results

Conclusion