|The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .|
CHICAGO – There is no significant difference in risk for atrial fibrillation (AF) or cardiovascular disease (CVD) following initiation of ustekinumab or a tumor necrosis factor inhibitor (TNFi) in patients with psoriasis (PsO) or psoriatic arthritis (PsA), according to the results of a large cohort study presented at the ACR/ARHP 2018 Annual Meeting, October 19-24, in Chicago, Illinois.
The investigators sought to explore the comparative CV risk with different biologic disease-modifying antirheumatic drugs in patients with PsO or PsA. They used 2 large US commercial databases — Optum Clinformatics and MarketScan — to identify patients with a diagnosis of either PsO or PsA who had initiated treatment with ustekinumab or a TNFi (ie, adalimumab, etanercept, infliximab, certolizumab, or golimumab) between September 25, 2009, and September 30, 2015.
The primary study outcome was incident AF. The secondary outcome comprised a composite CV event that included myocardial infarction, stroke, and coronary revascularization. All participants were followed until the first occurrence of 1 of the following events: study outcomes; death; plan disenrollment; switching agents; or discontinuing therapy.
A total of 60,028 adult patients with PsO or PsA and no prior AF were identified — 15,470 from Optum and 44,558 from MarketScan. Mean participant age was 47.2 ± 12.7 years; 51% of the patients were women. Among the participants, 81% had a diagnosis of PsO and 46% had PsA; 27% of the patients had both PsO and PsA.
Overall, 60 cases of incident AF were reported among 9071 people taking ustekinumab compared with 323 AF incident cases among 50,957 people taking a TNFi (incidence rate [IR], 4.7 and 5.0 cases per 1000 person-years, respectively). Major adverse cardiac events (MACE) occurred in 74 people taking ustekinumab vs 421 people taking a TNFi (IR, 6.2 and 6.1 cases per 1000 person-years, respectively). The combined hazard ratio for AF in those taking ustekinumab compared those taking a TNFi was 1.15 (95% CI, 0.70-1.89). For MACE, the hazard ratio was 1.14 (95% CI, 0.89-1.46).
The investigators concluded that although no substantial difference in risk for AF or CVD was reported following initiation of ustekinumab or TNFi therapy, a possible small effect cannot be ruled out. Additional studies with a longer follow-up period are thus warranted.
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Lee M, Desai RJ, Jin Y, Brill G, Ogdie A, Kim SC. Comparative risk of atrial fibrillation and cardiovascular events between TNF-inhibitors and ustekinumab in patients with psoriasis and psoriatic arthritis: a population-based multi-database study. Presented at: 2018 American College of Rheumatology/ Association of Rheumatology Health Professionals Annual Meeting; October 19-24, 2018; Chicago, IL. Abstract 1615.
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