Bonnie J. Dirr, APRN: In terms of response to steroid therapy for patients with chronic graft-vs-host disease [GVHD], what do you look for in terms of clinical evaluation criteria that you use looking at responses in knowing when it is considerably feasible to go ahead and taper a patient’s steroid dose in the setting of chronic graft-vs-host disease? We see here that you added ruxolitinib to CB’s regimen, in addition to his steroids [being] slightly tapered. Can you talk to us a little bit about how that management occurred for CB and then expand a little bit more for our audience, if possible, please?

Mahasweta Gooptu, MD: Yeah. Responses in chronic GVHD has been an interesting journey for the transplant community because as you can see, the evaluation is rather individualized and there aren’t a lot of objective metrics that you can use. Recognizing this, there was a real effort to standardize response assessments. If you are on a clinical trial, for example, the way your response would be assessed would be, do you have a complete response [CR] or a partial response [PR]? A complete response is complete resolution of the symptoms you presented with, then no progression in any other organ. A partial response would be reduction but not complete resolution of symptoms with no progression in other organs. CR and PR are typically the 2 types of response which are incorporated into clinical trial response assessments and combine to give you this overall response, which you’ll see mentioned in multiple publications. But I think in reality we often clinically assess the patient and we see that there is an improvement, but it doesn’t quite meet the criteria for complete response. I would say often we’ll see a patient as a partial response. When I see responses, I do start tapering steroids. I would say we taper steroids in 2 situations [where] we see a response. We start tapering steroids at different rates for different patients, but as fast as we possibly can, and some patients will have no further progression of their symptoms and no problems with their quality of life. You can taper them down to very low doses or off of steroids. The other situation is when we see the steroids are not working, and in that situation, we add a second agent for steroid refractory disease such as ruxolitinib or belumosudil; we now have all of these options which we did not have before. When we add these agents and we see a response, then we can start tapering the steroids or sometimes even before seeing a complete response, because we can see the steroids are not adding to the response and adding to toxicity. It becomes a little bit of a nuanced approach in that setting. But we don’t like steroids. We like other drugs which can give us the same benefit without the toxicities.

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