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Addition of peri-transplant ruxolitinib to sirolimus and tacrolimus for GvHD prophylaxis in patients with MF undergoing allo-HCT
Ruxolitinib, a JAK 1/2 inhibitor, is currently approved for use in patients with myelofibrosis, SR-aGvHD and SR-cGvHD. Adding ruxolitinib to tacrolimus and sirolimus peri-transplant for GvHD prophylaxis demonstrated efficacy and safety in a previous study. Malki et al. initiated a further study to assess the impact of adding peri-HCT ruxolitinib to Tac/Siro on clinical outcomes in patients with MF undergoing allo-HCT. In total, 141 patients with myelofibrosis were included in the study, with a median age of 64 years. Patients received PBSC HCT and Tac/Siro GvHD prophylaxis with (n = 58) or without (n = 83) additional ruxolitinib during 2009–2024 at a single center in the US. Results were presented by Yao at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT).
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Key learnings |
Neutrophil engraftment by Day 28 occurred in >96% of patients; no difference was observed with additional ruxolitinib (p = 0.76). Two-year relapse rate, DFS, and OS were 13.1%, 73.9%, and 79.7%, respectively, with no difference in these outcomes when adding peri-HCT ruxolitinib. |
Overall, cumulative incidences of Grade II–IV and III–IV aGvHD were 40.4% and 15.6%, respectively, at Day 100. The incidences of Grade II–IV and III–IV aGvHD were significantly lower in patients receiving peri-HCT ruxolitinib (25.9 vs 50.6%, p = 0.002; and 8.6 vs 20.6%, p = 0.05, respectively). |
The cumulative incidence of cGvHD at 12 months was 50%, with no significant difference between the two cohorts. Overall, GRFS was 44.1% at 12 months with additional ruxolitinib; providing a significant benefit compared with Tac/Siro alone (54.4% vs 37.1%; p = 0.005). |
In patients with MF undergoing PBSC HCT, the addition of peri-HCT ruxolitinib to Tac/Siro for GvHD prophylaxis led to improved GRFS and NRM, decreased incidence and severity of aGvHD, and did not affect neutrophil engraftment. A large-scale prospective study is needed to confirm these findings. |
Abbreviations: aGvHD, acute graft-versus-host disease; allo-HCT, allogeneic hematopoietic cell transplantation; cGvHD, chronic graft-versus-host disease; DFS, disease-free survival; GRFS, graft-versus-host disease-free, relapse-free survival GvHD, graft-versus-host disease; HCT, hematopoietic cell transplant; MF, myelofibrosis; OS, overall survival; PBSC, peripheral blood stem cell; Tac/Siro, tacrolimus/sirolimus.
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