You’re listening to GI Insights on ReachMD. I’m Dr. Peter Buch, and I recently had the chance to catch up with Dr. Phillip Ginsburg, who’s the Medical Director of Research and the Director of the Inflammatory Bowel Disease Center of Connecticut. Here’s Dr. Ginsburg now talking about the role of tofacitinib use.
So tofacitinib was studied for both ulcerative colitis and Crohn's disease. And it is indicated only in ulcerative colitis. The Crohn's program did not go beyond Phase II. And in ulcerative colitis, it is now indicated after it's positioned, after a patient has already seen an anti-TNF agent. It works very quickly, it's an orally dosed small molecule, so it's not a biologic, and it definitely has a role. It seems to be a very important medication in ulcerative colitis. So important that there are now several follow-on agents at various stages of drug development. This is a JAK inhibitor. It inhibits a specific pathway that is important in inflammatory disease in general. And it works roughly 60 percent of the time. So it definitely has an important role. There are potential downsides to Xeljanz that have been sort of well described that are unique to Xeljanz, which is tofacitinib. Those include not just, you know, allergic reactions and increased susceptibility to infections and the usual lymphoma, non-melanoma skin cancer, etc. But some unique aspects to tofacitinib is we see an increased risk of herpes roster's infection, so shingles. That risk maybe up to four times that of the general population. And that definitely is a signal that we want to be aware of when starting our patients on tofacitinib. So our patients we really should be vaccinating with the Shingrix series before starting tofacitinib.
Also, for reasons that are unclear, we'll see lipid elevations with tofacitinib. And the good news is that that is fairly predictable and can be monitored and treated quite easily, as well as the ratio between the LDL and HDL stay the same. That's the good and the bad cholesterol. So that is very easily treatable.
There also appears to be an increased risk of blood clots, and this includes deep vein thromboses, pulmonary embolisms, and other cardiovascular events. And there even have been deaths that have occurred, although it is important to note that this was seen primarily in a different patient population of rheumatoid arthritis patients who were of older age, who also were treated with concomitant methotrexate and had at least one cardiovascular comorbidity. So much is published and much is written, and there's a lot of angst about the risk of blood clots and DVTs and pulmonary emboli with tofacitinib. However, especially in our younger ulcerative colitis patient population who don't sort of check all of those boxes in terms of risk factors, it is generally considered a safe and well tolerated and quite effective medication.
So I do think that tofacitinib clearly has a role, and we're now really excited about several follow-on JAK-specific inhibitors that we hope to see approved within the next couple of years.
That was Dr. Phillip Ginsburg talking about the role of tofacitinib use. For ReachMD, I’m Dr. Peter Buch. To hear my full conversation with Dr. Ginsburg and to find other episodes in this series, visit ReachMD.com/GI-Insights, where you can Be Part of the Knowledge. Thanks for listening!