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Original article
Incidence of inpatient venous thromboembolism in treated patients with rheumatoid arthritis and the association with switching biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in the real-world setting
  1. Huifang Liang1,
  2. Raghava Danwada1,
  3. Dianlin Guo1,
  4. Jeffrey R Curtis2,
  5. Ryan D Kilpatrick1,
  6. Barbara Hendrickson3 and
  7. Syed S Islam1
  1. 1Global Epidemiology, Pharmacovigilance and Patient Safety, AbbVie Inc, North Chicago, Illinois, USA
  2. 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  3. 3Pharmacovigilance and Patient Safety, AbbVie Inc, North Chicago, Illinois, USA
  1. Correspondence to Dr Huifang Liang; huifang.liang{at}abbvie.com

Abstract

Objectives To assess incidence rates (IRs) of VTE in patients with rheumatoid arthritis (RA) on different DMARDs and DMARD switchers.

Methods Adults with RA on a DMARD between 2007 and 2017 were studied in a US claims database. Conventional synthetic DMARD (csDMARD) users, first biologic/targeted synthetic DMARD (b/tsDMARD) users and b/tsDMARD switchers (from a b/tsDMARD to another b/tsDMARD) were followed for inpatient VTE (pulmonary embolism (PE)/deep vein thrombosis (DVT)). Crude and adjusted IR and 95% CIs of VTE were estimated. HRs for VTE were estimated via Cox regression. VTE risk was also evaluated by number of switches between b/tsDMARDs and in patients without a VTE history.

Results The age and sex standardised IR (95% CI) of VTE (per 100 person-years) was 0.86 (0.70 to 1.03), 0.60 (0.52 to 0.68) and 0.58 (0.51 to 0.65) for b/tsDMARD switchers, first b/tsDMARD users and csDMARD users, respectively. After adjustment, b/tsDMARD switchers had an increased risk of VTE, compared with csDMARD users, HRadj (95% CI) being 1.36 (1.16 to 1.58), 1.36 (1.13 to 1.63) and 1.47 (1.18 to 1.83) for VTE, DVT and PE, respectively. Compared with first b/tsDMARD users, the HRadj (95% CI) for VTE was 1.35 (1.15 to 1.60) for first b/tsDMARD switchers and 1.48 (1.19 to 1.85) for second b/tsDMARD switchers.

Conclusions In RA, b/tsDMARD switchers have a higher VTE risk compared with csDMARD users and first b/tsDMARD users. Switching b/tsDMARDs may be a proxy for higher disease severity or poorly controlled RA and an important confounder to consider in obtaining unbiased estimates of VTE risk in observational RA safety studies.

  • rheumatoid arthritis
  • disease-modifying antirheumatic drugs (DMARDs)
  • cardiovascular disease
  • epidemiology

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Footnotes

  • Contributors HL contributed to study concept and design, data acquisition, data analysis, data interpretation, drafting of the initial manuscript, critical revision for important intellectual content and final approval of the manuscript. RD contributed to study design, data acquisition, data analysis, drafting of the manuscript, data interpretation, critical revision for important intellectual content and final approval of the manuscript. DG contributed to study concept and design, data analysis, data interpretation, drafting of the manuscript, critical revision for important intellectual content and final approval of the manuscript. JRC contributed to study design, drafting of the manuscript, critical revision for important intellectual content and final approval of the manuscript. RDK contributed to study design, drafting of the manuscript, critical revision for important intellectual content and final approval of the manuscript. BH contributed to data interpretation, drafting of the manuscript, critical revision for important intellectual content and final approval of the manuscript. SSI contributed to study concept and design, data analysis, data interpretation, drafting of the manuscript, critical revision for important intellectual content and final approval of the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

  • Funding This study was funded by AbbVie Inc.

  • Competing interests HL, RD, DG, RDK, BH and SSI are employees of AbbVie and own AbbVie stocks or stock options at the time of the study. JRC has received consulting fees from AbbVie, Amgen, BMS, CORRONA, Janssen, Lilly, Myriad and Pfizer; and research funding from AbbVie, Amgen, BMS, CORRONA, Janssen, Lilly, Myriad and Pfizer.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Supplemental data are available in a public, open-access repository. Data for this study may be obtained from a third party and are not publicly available. No company proprietary data are available. All data relevant to the study are included in the article or uploaded as online supplementary information.

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