No Differences in Incident AF and MACE Risk With Ustekinumab vs TNFi Use

Investigators assessed the risk for atrial fibrillation and major adverse cardiovascular events potentially related to using ustekinumab vs tumor necrosis factor inhibitors in patients with psoriasis or psoriatic arthritis.

There was no substantially different risk for incident atrial fibrillation (AF) or major adverse cardiovascular events (MACE) after beginning treatment with ustekinumab vs tumor necrosis factor inhibitors (TNFis), according to study results published in JAMA Dermatology.

In this cohort study, investigators identified patients age ≥18 years with psoriasis or psoriatic arthritis from multiple databases (N=60,028). The patients had started therapy with ustekinumab (n=9071) or TNFi (n=50,957) initiators and were required to have 12 months of continuous enrollment before the date of treatment initiation. Investigators followed the patients from this index date until the first occurrence of 1 of the outcomes of interest (AF or MACE), death, plan disenrollment, discontinuation of treatment, or the end of the study period. More than 60 predefined variables potentially associated with psoriatic disease severity and cardiovascular severity were measured during the 12-month baseline period.

After a mean follow-up of 1.4±1.3 years, there were 383 total diagnoses of incident AF (60 in patients being treated with ustekinumab and 323 in patients treated with TNFi initiators). Reported per 1000 person-years, the overall crude incidence rates for AF were 5 (95% CI, 3.8-6.5) in patients taking ustekinumab and 4.7 (95% CI, 4.2-5.2) in patients taking TNF initiators. The combined adjusted hazard ratio for ustekinumab initiators was 1.08 (95% CI, 0.76-1.54) for incident AF and 1.1 (95% CI, 0.8-1.52) for MACE when compared with TNFi initiators. A total of 495 cases of MACE were observed during follow-up in patients taking ustekinumab (n=74) and TNFis (n=421). The overall crude incidence rates were 6.2 (95% CI, 4.9-7.8) in the ustekinumab group and 6.1 (95% CI, 5.5-6.7) in the TNFi group.

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This study may be limited by potentially unmeasured or incompletely measured confounders, as is the case in any observational study. The key strength of this study is its large sample size of a diverse patient population.

Investigators found no overall differential risk for incident AF and MACE associated with the use of ustekinumab or TNFi. These findings are consistent with previous findings of no substatial difference in risk for cardiovascular events associated with the use of these biologic therapies and may serve as a hypothesis-generating basis for assessing the differential effects of these treatments.

Multiple authors declare affiliations with the pharmaceutical industry. Please refer to reference for a complete list of authors’ disclosures.

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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 [published online March 27, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2019.0001