In contrast to recent data on tofacitinib (Xeljanz) in rheumatoid arthritis, patients with inflammatory bowel disease (IBD) who received biologic therapies appeared to have a lower risk for a major adverse cardiovascular event (MACE) and venous thromboembolism (VTE).
The findings, presented at the American College of Gastroenterology (ACG) annual meeting, came from a propensity-matched TriNetX database analysis that compared outcomes in patients receiving newer biologic therapies and those on non-advanced therapies (immunomodulators, aminosalicylate drugs, steroids).
In this MedPage Today video, Miguel Regueiro, MD, of the Digestive Disease and Surgery Institute at the Cleveland Clinic, discusses the research.
Following is a transcript of his remarks:
We used the TriNetX database to look at biologic therapies and the small molecules, including upadacitinib [Rinvoq], tofacitinib, and ozanimod [Zeposia]. And what we were interested in seeing is whether or not these increased MACE (major adverse cardiovascular events) as well as VTE (venous thromboembolism) — so DVTs [deep vein thrombosis] and PEs [pulmonary embolisms].
The reason this is relevant — and you probably know this already — is there were some recent data on what’s called the ORAL Surveillance study, which found that tofacitinib in rheumatoid arthritis patients over the age of 50 who had cardiovascular risk, actually had a higher rate of clots and MACE. Because of that, the FDA restricted tofacitinib and upadacitinib to only be used after a TNF [tumor necrosis factor] inhibitor.
Our study actually did not find an increase in MACE or VTE with these therapies. In fact, with biologics, the monoclonal antibodies, we saw a lower rate of MACE and VTE. Why may you ask? That may be because decreasing systemic inflammation actually decreases the cardiovascular and clot risk. That’s a hypothesis. I can’t prove it from the studies, but that’s one of the theories we have. And then with the small molecules, including the JAK [Janus kinase] inhibitors, we did not see any increase in MACE or VTE. So whether a patient was on one of these therapies or not, there was no difference. It was basically flat.
I think this reassures us as gastroenterologists in using these therapies. We think they’re very safe. We’re not seeing an increase in MACE or VTE. The main question that will be asked — and I don’t have the answer today — is whether or not the FDA will change the label to allow first-line tofacitinib, first-line upadacitinib for our inflammatory bowel disease patients. That remains to be seen, but I think this data is compelling and also confirms what we’ve seen before.