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Original Investigation
March 27, 2019

Association of Ustekinumab vs TNF Inhibitor Therapy With Risk of Atrial Fibrillation and Cardiovascular Events in Patients With Psoriasis or Psoriatic Arthritis

Author Affiliations
  • 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • 2Department of Epidemiology, University of North Carolina, Chapel Hill
  • 3Center for Clinical Epidemiology and Biostatistics, Department of Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia
  • 4Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia
  • 5Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA Dermatol. 2019;155(6):700-707. doi:10.1001/jamadermatol.2019.0001
Key Points

Question  What are the risks of atrial fibrillation and major adverse cardiovascular events associated with the use of ustekinumab compared with the use of tumor necrosis factor (TNF) inhibitors among patients with psoriasis or psoriatic arthritis?

Findings  In this cohort study that included data on 60 028 patients with psoriasis or psoriatic arthritis from multiple databases, no significant difference was found in the risk of developing atrial fibrillation or major adverse cardiovascular events after initiation of therapy with ustekinumab vs a TNF inhibitor.

Meaning  The risks of atrial fibrillation and major adverse cardiovascular events associated with the use of ustekinumab vs TNF inhibitors were not different in patients with psoriasis or psoriatic arthritis; further investigations on potentially modifying treatment effects stratified by important risk factors may be warranted.

Abstract

Importance  Accumulating evidence indicates that there is an increased risk of cardiovascular disease among patients with psoriatic disease. Although an emerging concern that the risk of atrial fibrillation (AF) may also be higher in this patient population adds to the growing support of initiating early interventions to control systemic inflammation, evidence on the comparative cardiovascular safety of current biologic treatments remains limited.

Objective  To evaluate the risk of AF and major adverse cardiovascular events (MACE) associated with use of ustekinumab vs tumor necrosis factor inhibitors (TNFi) in patients with psoriasis or psoriatic arthritis.

Design, Setting, and Participants  This cohort study included data from a nationwide sample of 78 162 commercially insured patients in 2 US commercial insurance databases (Optum and MarketScan) from September 25, 2009, through September 30, 2015. Patients were included if they were 18 years or older, had psoriasis or psoriatic arthritis, and initiated ustekinumab or a TNFi therapy. Exclusion criteria included history of AF or receipt of antiarrhythmic or anticoagulant therapy during the baseline period.

Exposures  Initiation of ustekinumab vs TNFi therapy.

Main Outcomes and Measures  Incident AF and MACE, including myocardial infarction, stroke, or coronary revascularization.

Results  A total of 60 028 patients with psoriasis or psoriatic arthritis (9071 ustekinumab initiators and 50 957 TNFi initiators) were included in the analyses. The mean (SD) age was 46 (13) years in Optum and 47 (13) in MarketScan, and 29 495 (49.1%) were male. Overall crude incidence rates (reported per 1000 person-years) for AF were 5.0 (95% CI, 3.8-6.5) for ustekinumab initiators and 4.7 (95% CI, 4.2-5.2) for TNFi initiators, and for MACE were 6.2 (95% CI, 4.9-7.8) for ustekinumab initiators and 6.1 (95% CI, 5.5-6.7) for TNFi initiators. The combined adjusted hazard ratio for incident AF among ustekinumab initiators was 1.08 (95% CI, 0.76-1.54) and for MACE among ustekinumab initiators was 1.10 (95% CI, 0.80-1.52) compared with TNFi initiators.

Conclusions and Relevance  No substantially different risk of incident AF or MACE after initiation of ustekinumab vs TNFi was observed in this study. This information may be helpful when weighing the risks and benefits of various systemic treatment strategies for psoriatic disease.

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