title: Increased risk of venous thromboembolic events with corticosteroid vs biologic therapy for inflammatory bowel disease.
abstract: OBJECTIVE
  We investigated whether treatment of active inflammatory bowel disease with biologic agents is associated with a reduced risk of venous thromboembolic events (VTEs) compared with corticosteroid therapy.
  
  
  METHODS
  We performed a retrospective analysis of 15,100 adults with inflammatory bowel disease who were identified from the Truven Health MarketScan databases. We analyzed data from patients who received 6 months of continuous medical and prescription coverage before and 12 months after their first diagnosis and had no VTE during the 6 months before they first received biologic or corticosteroid therapy. The outcome assessed was any VTE that occurred during the 12-month follow-up period. A multivariate logistic regression model was used to evaluate the effects of biologic, corticosteroid, and combination therapies (biologics and corticosteroids) on VTE risk.
  
  
  RESULTS
  Three hundred twenty-five VTEs occurred during the study period (in 2.25% of patients receiving only corticosteroids, in 0.44% of patients receiving biologics, and in 2.49% of patients receiving combination therapy). Compared with patients receiving only corticosteroids, the odds ratio for VTE in patients receiving only biologics was 0.21 (95% confidence interval, 0.05-0.87) in the multivariate model, and the odds ratio for VTE in patients on combination therapy was 1.01.
  
  
  CONCLUSIONS
  Compared with treatment with only a biologic agent, corticosteroid therapy is associated with a nearly 5-fold increase in risk for VTE. Combination therapy with corticosteroids and biologic agents was associated with the same risk for VTE as that of corticosteroids alone. Corticosteroids therefore appear to increase risk for VTE.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Michigan, Ann Arbor, Michigan. Electronic address: phiggins@umich.edu.
authors.forename: Peter D R
authors.initials: PD
authors.lastname: Higgins
authors.affiliation: Global Health Economics and Outcomes Research, AbbVie Inc, North Chicago, Illinois.
authors.forename: Martha
authors.initials: M
authors.lastname: Skup
authors.affiliation: Global Health Economics and Outcomes Research, AbbVie Inc, North Chicago, Illinois.
authors.forename: Parvez M
authors.initials: PM
authors.lastname: Mulani
authors.affiliation: Novosys Health, Flemington, New Jersey.
authors.forename: Jay
authors.initials: J
authors.lastname: Lin
authors.affiliation: Global Health Economics and Outcomes Research, AbbVie Inc, North Chicago, Illinois.
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001691:Biological Therapy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment; D054556:Venous Thromboembolism / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones
keywords: CD; IBD; Intestinal Inflammation; Risk Factor; Ulcerative Colitis