4.6 Article

Risk of Venous Thromboembolism in Patients with Rheumatoid Arthritis: Initiating Disease-Modifying Antirheumatic Drugs

Journal

AMERICAN JOURNAL OF MEDICINE
Volume 128, Issue 5, Pages -

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.amjmed.2014.11.025

Keywords

Disease-modifying antirheumatic drugs; Rheumatoid arthritis; Venous thromboembolism

Funding

  1. National Institutes of Health (NIH) [K23 AR059677]
  2. Pfizer
  3. Pharmaceutical Research and Manufacturers of America
  4. Pharmacoepidemiology Program at the Harvard School of Public Health
  5. NIH [K24 AR055989, P60 AR047782, R01 AR056215]
  6. Amgen
  7. Lilly
  8. Novartis
  9. Bristol-Myers Squibb
  10. NIH
  11. AstraZeneca
  12. Agency for Healthcare Research and Quality
  13. U.S. Food and Drug Administration
  14. WHISCON
  15. LLC
  16. Aetion, Inc
  17. Boehringer Ingelheim
  18. Harvard-Brigham Drug Safety and Risk Management Research Contract

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OBJECTIVES: Recent research suggests that rheumatoid arthritis increases the risk of venous thromboembolism. This study compared the risk of venous thromboembolism in patients with newly diagnosed rheumatoid arthritis initiating a biologic disease-modifying antirheumatic drug (DMARD) with those initiating methotrexate or a nonbiologic DMARD. METHODS: We conducted a population-based cohort study using US insurance claims data (2001-2012). Three mutually exclusive, hierarchical DMARD groups were used: (1) a biologic DMARD with and without nonbiologic DMARDs; (2) methotrexate without a biologic DMARD; or (3) nonbiologic DMARDs without a biologic DMARD or methotrexate. We calculated the incidence rates of venous thromboembolism. Cox proportional hazard models stratified by propensity score (PS) deciles after asymmetric PS trimming were used for 3 pairwise comparisons, controlling for potential confounders at baseline. RESULTS: We identified 29,481 patients with rheumatoid arthritis with 39,647 treatment episodes. From the pairwise comparison after asymmetric PS trimming, the incidence rate of hospitalization for venous thromboembolism per 1000 person-years was 5.5 in biologic DMARD initiators versus 4.4 in nonbiologic DMARD initiators and 4.8 in biologic DMARD initiators versus 3.5 in methotrexate initiators. The PS decile-stratified hazard ratio of venous thromboembolism associated with biologic DMARDs was 1.83 (95% confidence interval [CI], 0.91-3.66) versus nonbiologic DMARDs and 1.39 (95% CI, 0.73-2.63) versus methotrexate. The hazard ratio of venous thromboembolism in biologic DMARD initiators was the highest in the first 180 days versus nonbiologic DMARD initiators (2.48; 95% CI, 1.14-5.39) or methotrexate initiators (1.80; 95% CI, 0.90-3.62). CONCLUSIONS: The absolute risk for venous thromboembolism was low in patients with newly diagnosed rheumatoid arthritis. Initiation of a biologic DMARD seems to be associated with an increased short-term risk of hospitalization for venous thromboembolism compared with initiation of a nonbiologic DMARD or methotrexate. (C) 2015 Elsevier Inc. All rights reserved.

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