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?
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.
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.
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.
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.
Initiation of ustekinumab vs TNFi therapy.
Main Outcomes and Measures
Incident AF and MACE, including myocardial infarction, stroke, or coronary revascularization.
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.
Lee MP, Desai RJ, Jin Y, Brill G, Ogdie A, Kim SC. Association of Ustekinumab vs TNF Inhibitor Therapy With Risk of Atrial Fibrillation and Cardiovascular Events in Patients With Psoriasis or Psoriatic Arthritis. JAMA Dermatol. Published online March 27, 2019155(6):700–707. doi:10.1001/jamadermatol.2019.0001
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