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KMID : 0869620230400020183
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Journal of Korean Society of Hospital Pharmacists
2023 Volume.40 No. 2 p.183 ~ p.194
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Evaluation of Ruxolitinib for Steroid-Refractory Graft-versus-Host Disease in Hospital
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Choi Ji-Won
Guem Min-Jung
Ko Jong-Hee
Son Eun-Sun
Yu Yun-Mi
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Abstract
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Background : Graft-versus-host disease (GVHD) is a complication reported in 30?50% of patients who receive homologous hematopoietic stem cell transplantation. Although systemic corticosteroids are recommended as primary treatment, approximately 50% develop steroid-refractory GVHD (SR-GVHD) with high mortality. In May 2022, ruxolitinib was approved by the Ministry of Food and Drug Safety for the treatment of SR-GVHD, but there is limited data on treatment responses in Korean patients. The purpose of this study was to evaluate the effectiveness of ruxolitinib in patients with SR-GVHD.
Methods : We enrolled patients with GVHD who had received ruxolitinib treatement at Severance Hospital between January 2017 to July 2022. We evaluated the overall response rate (ORR) and non-relapse mortality (NRM) at the time of ruxolitinib discontinuation. Patients and GVHD characteristics were analyzed according to the responder and non-responder groups of ruxolitinib, and the steroid-sparing effect was estimated based on whether the co-administered steroids were reduced.
Results : There were no significant differences in baseline patient characteristics and GVHD characteristics between the responder and non-responder groups. The overall responsive rate (ORR) for ruxolitinib was 50% (22 of 44 patients). During the administration of ruxolitinib, 91% of responders and 46% of non-responders experienced a reduction of steroid dose reduction (p<0.01). The NRM was 10% in the responder group and 64% in the non-responder group (p<0.01), and the main cause of death was infection.
Conclusion : The results demonstrate that ruxolitinib has a steroid-sparing effect in patients with SR-GVHD, as evidenced by the higher number of patients who experienced steroid dose reduction and the lower NRM in responders than non-responders. This suggests the possibility of reducing steroid-induced infection risk and mortality.
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KEYWORD
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Steroid refractory GVHD (SR-GVHD), Ruxolitinib, Overall response rate (ORR), Non-relapse mortality (NRM), Steroid-sparing effect
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