Abstract
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.
Keywords
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Article info
Publication history
Published online: December 19, 2014
Footnotes
Funding: None.
Conflict of Interest: Disclosures: SCK is supported by National Institutes of Health (NIH) Grant K23 AR059677 and received research support from Pfizer and tuition support for the Pharmacoepidemiology Program at the Harvard School of Public Health, partially funded by the Pharmaceutical Research and Manufacturers of America. DHS is supported by NIH Grants K24 AR055989, P60 AR047782, and R01 AR056215; received research grants from Amgen and Lilly; and serves in unpaid roles on studies sponsored by Pfizer, Novartis, Lilly, and Bristol-Myers Squibb. RJG received research grants from the NIH, AstraZeneca, and Novartis. SS is principal investigator of the Brigham and Women's Hospital DEcIDE Center on Comparative Effectiveness Research, funded by the Agency for Healthcare Research and Quality, and of the Harvard-Brigham Drug Safety and Risk Management Research Contract, funded by the U.S. Food and Drug Administration; received consulting fees from WHISCON, LLC, and Aetion, Inc; and is the Principal Investigator of research grants from Pfizer, Novartis, and Boehringer Ingelheim.
Authorship: All authors had access to the data and played a role in writing this manuscript.
Identification
Copyright
© 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
