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Dr. Christina Charles-Schoeman, chief of rheumatology, recently published important findings from the FDA mandated post authorization, safety end-point trial, ORAL Surveillance, examining risk of major adverse cardiovascular events (MACE) with the Janus kinase (JAK) inhibitor, tofacitinib, compared to tumor necrosis factor inhibitors (TNFi), commonly prescribed and effective medications for patients with rheumatoid arthritis (RA). RA patients have a two to three-fold increased risk of cardiovascular disease, which is related to traditional CV risk factors as well as high levels of RA disease activity.

The primary analyses of ORAL Surveillance, which included over 4000 RA patients aged ≥50 years with ≥1 additional CV risk factor found an increased risk of MACE with tofacitinib versus TNFi. This “post hoc” analysis by Dr. Charles-Schoeman and colleagues, identified increased risk of MACE primarily in patients with a history of pre-existing atherosclerotic cardiovascular disease (ASCVD) (15% of patients enrolled). In patients without a history of ASCVD but with CV risk factors (85% of patients), there did not appear to be a detectable difference in risk of MACE with tofacitinib versus TNFi.

Dr. Charles-Schoeman notes this is a significant development, as tofacitibib is an important drug in controlling RA disease activity, and we want to make sure that in treating patients for this common autoimmune disease, we should not be prescribing medications that will place them at higher risk for atherosclerotic cardiovascular disease. It is important to note that the overall incidence of cardiovascular events was low across this high-risk population who were all treated actively with either tofacitinib or TNFI to control RA disease activity.

You can review the entire publication in Annals of Rheumatic Diseases. Future work by Dr. Charles-Schoeman and her team will be focusing on using biospecimens from the tofacitinib clinical trial program to identify a new biomarker of cardiovascular risk in RA patients. We look forward to reading those results!