Inside the Clinic: Graft-versus-Host Disease Best Practices - Episode 11
Zachariah DeFilipp, MD: The randomized data from the REACH2 study builds on the promising results of with ruxolitinib from the REACH-1 study. Ruxolitinib has already received FDA approval for the treatment of steroid-refractory graft-vs-host disease based on the results of the REACH-1 study. In that single-arm study, the overall response rate for patients with steroid-refractory graft-vs-host disease was 57%, with 31% complete response rate.
A limitation of the REACH-1 study though was that it was a single-arm study. In REACH2, 309 patients were randomized between treatment with ruxolitinib or best-available therapy. In that study, the 28-day overall response rate was 62% for ruxolitinib versus 39% for best-available therapy. The responses to ruxolitinib were durable.
With the promising results of REACH-1 and the confirmation of these results, in the randomized REACH2 study, ruxolitinib is likely to be adopted as a new standard in the treatment of steroid-refractory acute graft-vs-host disease and also sets the new bar for future studies moving forward.
Yi-Bin Chen, MD: With the FDA approval of ruxolitinib, it has become a standard of care for the treatment of steroid-refractory acute graft-vs-host disease. Certainly, these findings have been validated by the REACH2 study, and it certainly is a really compelling agent to use. Our personal experience is very good with ruxolitinib. We’ve used it definitely in the setting of steroid-refractory acute graft-vs-host disease. My practical advice to people would be that it’s often helpful to have it on formulary in your inpatient hospital. The nature of steroid-refractory acute graft-vs-host disease is that many of your patients will be inpatient with lower GI [gastrointestinal] disease, and it’s difficult to make a decision to use a second-line therapy and not have access to drug while you’re waiting for outpatient approval. Having it on your inpatient formulary as a “bridge supply” before the outpatient supply can be secured is probably a really important thing to be able to use it in a timely fashion.
We’ve had very good experience with it. It works really well for cutaneous in the refractory setting. It works less well for lower GI disease, but that’s true for any therapy. Those are the sickest patients and still a population that has an unmet need. In terms of toxicity management, we’ve actually had a really good experience and haven’t encountered a lot of toxicities. I can’t remember 1 patient who we’ve had to stop drug in the steroid-refractory acute GVHD setting because of toxicity. We definitely have seen the cytopenias, both anemia and thrombocytopenia, that have been reported in not only the GVHD population but also the other settings in which ruxolitinib is used. Our experience is that these cytopenias can easily be managed either by transfusional support if you feel that dose is needed or by dose adjustments of the drug, which can lessen its impact on cytopenias.
Transcript Edited for Clarity