Dr Regueiro reviews research from Cleveland Clinic that took a closer look at whether biologics and small molecule therapies increase the risk of major cardiovascular events among patients with inflammatory bowel disease, which he presented at the American College of Gastroenterology scientific meeting.

Miguel Regueiro, MD, is professor of medicine and chair of the Digestive Disease & Surgery Institute at Cleveland Clinic in Cleveland, Ohio. 

I'm Dr. Miguel Regueiro. I'm professor of Medicine and the chief of the Digestive Disease Institute at Cleveland Clinic in Cleveland, Ohio. I'm coming to you from ACG 2023 in beautiful Vancouver, Canada. Hopefully a lot of you have been able to make the meeting and saw some of these presentations. But in case you missed it, one of the highlights was a presentation I gave on Monday of ACG in the Presidential Plenary Session. This was a presentation where we used the TriNetX database to look at biologic therapies and the small molecules, including upadacitinib, tofacitinib, and ozanimod. And what we were interested in seeing is whether or not these increased MACE, major adverse cardiovascular events, as well as VTE, venothromboembolism—DVTs and PEs.

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 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 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.

Thank you very much for attending ACG, and I hope to see you all soon.