Abstract
We compared long-term outcomes in 78 patients with steroid-refractory acute graft-versushost disease (SR-aGVHD) treated at the University Medical Center Hamburg, Germany between December 2015 and August 2022 who received either ruxolitinib alone (Ruxo, n=29) or Ruxo plus extracorporeal photopheresis (Ruxo-ECP, n=49). Patients were well balanced between both arms except for SR-aGVHD grade IV which was higher in the Ruxo-ECP group (45% vs. 14%, p<0.001). In both cohorts, steroids were tapered rapidly, and median steroid treatment was 39 days in Ruxo and 35 days in Ruxo-ECP. The overall response rate (ORR) including complete remissions (CR) of aGVHD at day 28 was 90% and 31% for Ruxo versus 86% and 0% (p<0.001, respectively) for Ruxo-ECP. At 6 months, PR and CR remission status of evaluable patients was 11% and 50% in Ruxo-ECP vs 10% and 40% after Ruxo alone, respectively (p=0.018). At 12 months, PR and CR remisson status was 6% and 17% in the Ruxo group, but 82% and 64% (p<0.001) in Ruxo-ECP cohort and the cumulative incidence of chronic GVHD was significantly higher after Ruxo versus Ruxo-ECP, being 49% (95% CI: 33-69%) vs. 24% (95% CI: 15-38%, p= 0.01). Reconstitution of B-cells occurred significantly earlier at 1 and 3 months in the Ruxo arm. No difference in 1-year NRM, relapse, and 2-year overall survival was observed. Despite the limitations of this retrospective single-center study, the data suggest a better long-term control of aGVHD and less chronic GVHD at 1 year combining ruxolitinib with ECP compared to ruxolitinib alone in SR-aGVHD.
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