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Ruxolitinib versus basiliximab for steroid-refractory acute graft-versus-host disease: a retrospective study

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Abstract

Acute graft-versus-host disease (aGVHD) remains a major limitation of allogeneic hematopoietic stem cell transplantation; not all patients respond to standard glucocorticoids treatment. This study retrospectively evaluated the effects of ruxolitinib compared with basiliximab for steroid-refractory aGVHD (SR-aGVHD). One hundred and twenty-nine patients were enrolled, 81 in ruxolitinib and 48 in basiliximab group. The overall response (OR) at day 28 was higher in ruxolitinib group (72.8% vs. 54.2%, P = 0.031), as with complete response (CR) (58.0% vs. 35.4%, P = 0.013). Ruxolitinib led to significantly lower 1-year cumulative incidence of chronic GVHD (cGVHD) (29.6% vs. 43.8%, P = 0.021). Besides, ruxolitinib showed higher 1-year overall survival (OS) and 1-year cumulative incidence of failure-free survival (FFS) (OS: 72.8% vs. 50.0%, P = 0.008; FFS: 58.9% vs. 39.6%, P = 0.014). The 1-year cumulative incidence of non-relapse mortality (NRM) was lower in ruxolitinib group (16.1% vs. 37.5%, P = 0.005), and the 1-year relapse was not different. The 1-year cumulative incidence of cytomegalovirus (CMV) viremia, CMV-associated diseases and Epstein-Barr virus (EBV)-associated diseases was similar between the two groups, but EBV viremia was significantly lower in ruxolitinib group (6.2% vs. 29.2%, P < 0.001). Subgroup analyses revealed that OR and survival were similar in ruxolitinib 5 mg twice daily (bid) and 10 mg bid groups. However, ruxolitinib 10 mg bid treatment markedly reduced 1-year cumulative incidence of cGVHD compared with 5 mg bid (21.1% vs. 50.0%, P = 0.016). Our study demonstrated that ruxolitinib was superior to basiliximab in SR-aGVHD treatment and cGVHD prophylaxis, therefore should be recommended.

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Data availability

The dataset supporting the conclusions of this article is available in the clinical data repository of Nanfang hospital. Individual participant data were not shared. For the original data, please contact echohua1124@163.com.

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Acknowledgements

We thank the patients, their families, and their caregivers; co-investigators, collaborators, and members of the study team involved in this study.

Funding

This study was funded by the National Natural Science Foundation of China (No. 82170215, 81970161 and 81870144) and Special Project for Research and Development in Key areas of Guangdong Province (No.2019B020236004).

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  1. Jiapei Liu, Zhiping Fan and Na Xu have contributed equally to this work.

Authors and Affiliations

  1. Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China

    Jiapei Liu, Zhiping Fan, Na Xu, Jieyu Ye, Yanqiu Chen, Ruoyang Shao, Yiming Sun, Qiaoyuan Wu, Qifa Liu & Hua Jin

  2. Department of Hematology, Maoming People’s Hospital, Maoming, China

    Yanqiu Chen

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  1. Jiapei Liu
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Hua Jin designed the study; Jiapei Liu, Zhiping Fan and Na Xu performed the analyses and wrote the manuscript; Ruoyang Shao, Yiming Sun, Qiaoyuan Wu collected clinical data; Qifa Liu, Jieyu Ye, Yanqiu Chen performed data interpretation; all authors revised, corrected, and approved the manuscript.

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Liu, J., Fan, Z., Xu, N. et al. Ruxolitinib versus basiliximab for steroid-refractory acute graft-versus-host disease: a retrospective study. Ann Hematol 102, 2865–2877 (2023). https://doi.org/10.1007/s00277-023-05361-9

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