AI Article Synopsis
- The study aimed to assess the risk of major adverse cardiovascular events (MACE) in patients with rheumatoid arthritis (RA) taking tofacitinib compared to those using tumor necrosis factor inhibitors (TNFi), particularly focusing on individuals with or without a history of atherosclerotic cardiovascular disease (ASCVD).
- Results indicated that tofacitinib users had a higher risk of MACE, myocardial infarction, and sudden cardiac death compared to TNFi, especially in patients with a history of ASCVD.
- Although MACE risk for tofacitinib was not significantly different in patients without ASCVD, the analysis concluded that further investigation is needed due to its exploratory nature and limited statistical power.
Article Abstract
Objectives: Evaluate risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA) with or without a history of atherosclerotic cardiovascular disease (ASCVD) in ORAL Surveillance.
Methods: Patients with RA aged ≥50 years with ≥1 additional CV risk factor received tofacitinib 5 mg or 10 mg two times per day or TNFi. Hazard rations (HRs) were evaluated for the overall population and by history of ASCVD (exploratory analysis).
Results: Risk of MACE, myocardial infarction and sudden cardiac death were increased with tofacitinib versus TNFi in ORAL Surveillance. In patients with history of ASCVD (14.7%; 640/4362), MACE incidence was higher with tofacitinib 5 mg two times per day (8.3%; 17/204) and 10 mg two times per day (7.7%; 17/222) versus TNFi (4.2%; 9/214). HR (combined tofacitinib doses vs TNFi) was 1.98 (95% confidence interval (CI) 0.95 to 4.14; interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)). In patients without history of ASCVD, MACE HRs for tofacitinib 5 mg two times per day (2.4%; 30/1251) and 10 mg two times per day (2.8%; 34/1234) versus TNFi (2.3%; 28/1237) were, respectively, 1.03 (0.62 to 1.73) and 1.25 (0.76 to 2.07).
Conclusions: This post hoc analysis observed higher MACE risk with tofacitinib versus TNFi in patients with RA and history of ASCVD. Among patients without history of ASCVD, all with prevalent CV risk factors, MACE risk did not appear different with tofacitinib 5 mg two times per day versus TNFi. Due to the exploratory nature of this analysis and low statistical power, we cannot exclude differential MACE risk for tofacitinib 5 mg two times per day versus TNFi among patients without history of ASCVD, but any absolute risk excess is likely low.
Trial Registration Number: NCT02092467.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9811099 | PMC |
| http://dx.doi.org/10.1136/ard-2022-222259 | DOI Listing |
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