Tapering Approaches for Patients With Steroid-Refractory Chronic GVHD

Opinion
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Catherine Lee, MD, MS, details her approaches to tapering steroids in a refractory patient with chronic graft-versus-host disease and the efficacy of different treatments based on organ involvement.

Nelson Chao, MD, MBA: I want to go back to a comment that Erin made earlier, which is: we add drug after drug after drug. So, do you taper them off steroids if you have the ruxolitinib? Or what do you do with this in somebody who's refractory, Catherine?

Catherine Lee, MD, MS: Yes. So, we would taper off the steroids in someone who's been deemed as refractory. This is also very dependent, I think, on the institution. The Hutch has a long history of using steroids and being a little slower on the taper; but I think other institutions would feel comfortable in terms of rapidly tapering off the steroids. I don't know; I'd be interested in hearing how your institution works. What I wanted to add was in response to your comment about organs. We know that in the REACH trials for acute graft-versus-host disease, there was a response; but the responses and the duration of the response were not so great among those who had gastrointestinal involvement, particularly severe gastrointestinal involvement. This kind of leads to the unmet need that we are still facing: understanding what therapy may fit best for a particular organ. This is an area of research if we can identify and develop biomarkers that will help guide treatment for different manifestations of graft-versus-host disease. I just wanted to point that out.

Nelson Chao, MD, MBA: Erin, any other comments on this?

Erin Kopp, NP: In reference to the steroid comment, I think that my experience has been that we are less excited about tapering the steroids even when it seems that they're refractory. I think it's just practice, and it's like a safety network custom to the steroids. There's the fear that if you reduce the steroids and you had some effect, then if you take the steroids away, the disease will flare even more. So, anecdotally, I see very much what you said, Dr. Lee. There's a reliance on keeping those steroids as you add ruxolitinib or any other agent on top of it. With any agent that is PO, including ruxolitinib, there has been hesitancy to utilizing it with patients who have GI presentations. With the REACH studies, I can see we talk originally about: well, there doesn't seem to be an issue with absorption and utilization unless we know there's a significant issue with a patient with absorption, but there is efficacy to a certain level. And that's where you start combining: well, I'm going to use the steroids for this, and then the ruxolitinib may or may not give the effect, or it'll give the effect but not the duration of response. Then adding another agent on top of it if we're talking about different organs. What I have noticed in the last five years is that the addition of agents is definitely more intentional. The conversations that I'm listening to right now and getting to be a part of, people are looking at not just what is the etiology, the mechanism of action of the drug, the organs that are affected, and the research that's involved; it's because it's such a complex illness, a complex process. And that, I think, is the difference in what leads to success as opposed to not. Before, I would describe it as: well, there's a dartboard, and you just throw everything at it and see what sticks. Then you have to look at the bullseye and see what you pull off. Now, there's a lot of ingredients, but we're all more experienced with how it will affect the overall outcome. But I don't think we've yet achieved a space where we could all sit in a room and say: well, I'm going to do this as step one, this as step two, this as step three today, and then what we're going to continue to study in the future.

Nelson Chao, MD, MBA: That was well said. I think one of the things that we always discuss is, is graft-versus-host is one disease, or is it multiple diseases? You go to a rheumatologist, and they don’t say you have an autoimmune disease. There's a name for some of these diseases. It depends whether you're a split or a lumper, whether you want to call everything the same. And maybe the pathophysiology is slightly different from different tissues, where ECP works really well for the skin, but maybe not so well for some of the other organs. So, it's an interesting conversation. I guess time will tell as we get more into the biology of this disease to try to understand it more.

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