Major cardiac event risk similar for ustekinumab, TNF inhibitors in PsA, psoriasis
There is no substantial difference in the risks for atrial fibrillation and major adverse cardiovascular events between ustekinumab and TNF inhibitors among patients with psoriatic arthritis or psoriasis, according to data published in JAMA Dermatology.
“Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk,” Seoyoung C. Kim, MD, ScD, MSCE, of Brigham and Women’s Hospital and Harvard Medical School, told Healio Rheumatology. “Our study has an important clinical implication as the number of treatment options for psoriasis and psoriatic arthritis has been rising over the past few decades and physicians and patients need to choose an agent based on the benefit-risk profile of the drug.”
To analyze the risk for atrial fibrillation and major adverse cardiovascular events associated with ustekinumab (Stelara, Janssen) compared with TNF inhibitors in patients with psoriasis or PsA, Kim and colleagues studied data from two nationwide databases of U.S. commercial health care insurance claims — Optum Clinformatics and Truven Health Analytics. Focusing on adult patients who began treatment with either ustekinumab or a TNF inhibitor, and had a coded visit from Sept. 25, 2009, through Sept. 30, 2015, the researchers identified a study sample of 78,162.
After excluding patients with prior atrial fibrillation and those who received antiarrhythmic or anticoagulant therapy during the baseline period, 60,028 individuals, including 9,071 treated with ustekinumab and 50,957 treated with a TNF inhibitor, were evaluated in the final analysis. All patients were followed until incident atrial fibrillation or major adverse cardiovascular event, death, planned disenrollment, prescription change, treatment discontinuation or end of study period.
According to the researchers, the overall crude incidence rate for atrial fibrillation among patients treated with ustekinumab was five per 1,000 patient-years (95% CI, 3.8-6.5). For individuals who received a TNF inhibitor, the incidence rate for atrial fibrillation was 4.7 per 1,000 patient-years (95% CI, 4.2-5.2). For major cardiovascular events, including myocardial infarction, stroke or coronary revascularization, incident rates were 6.2 per 1,000 patient-years (95%CI, 4.9-7.8) for patients treated with ustekinumab and 6.1 per 1,000 patient-years (95% CI, 5.5-6.7) for those who received TNF inhibitors.
The combined adjusted HR for atrial fibrillation in patients who received ustekinumab was 1.08 (95% CI, 0.76-1.54) compared with those treated with TNF inhibitors. The combined adjusted HR for major cardiovascular events was 1.1 in patients treated with ustekinumab (95% CI, 0.8-1.52), compared with the TNF-inhibitor group.
“In our large cohort study of over 60,000 patients with psoriasis or psoriatic arthritis who initiated ustekinumab vs. a TNF inhibitor, we found overall no difference in the risk of incident atrial fibrillation, or a composite CV endpoint of myocardial infarction, stroke and coronary revascularization,” Kim said. “While the comparative safety of these drugs needs to be further examined in subgroups of patients as more data get accumulated in the future, the current study provides CV safety data from an important head-to-head comparison — the two most commonly used categories of biologic drugs for the conditions — in a real-world setting.” – by Jason Laday
Disclosure: Kim reports research support to Brigham and Women’s Hospital from Bristol-Myers Squibb, Pfizer and Roche. Please see the full study for all other relevant financial disclosures.