American journal of translational research · 2026
Efficacy and safety of autologous hematopoietic stem cell transplantation for refractory systemic sclerosis after rituximab-bendamustine conditioning.
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Zheng Chaoen, Liu Zhenghai, Li Sha, Chen Jianjia, Zhang Yanming
Аннотация
OBJECTIVES: To evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (auto-HSCT) using a novel rituximab-bendamustine conditioning regimen in patients with refractory systemic sclerosis (SSc).
METHODS: This retrospective cohort study enrolled 216 patients with refractory SSc who received treatment between August 2019 and August 2023. Participants were divided into a transplant group (n=104) receiving the novel auto-HSCT regimen, and a conventional group (n=112) treated with prednisone combined with cyclophosphamide. Efficacy indicators, including the modified Rodnan skin score (mRSS), pulmonary, cardiac and renal function, organ involvement manifestations, autoantibody titers, quality of life (SF-36) scores, and clinical remission status, were assessed at baseline and 24 weeks post-treatment. Adverse events and progression-free survival (PFS) were also analyzed.
RESULTS: At the 24-week follow-up, the transplant group achieved significantly greater mRSS improvement (P<0.001). Significant improvements were also observed in pulmonary function (forced vital capacity [FVC], P=0.009) and cardiac function (left ventricular ejection fraction [LVEF], P=0.005) in the transplant group. The transplant group had a higher overall clinical remission rate (75.00% vs. 60.71%) and longer PFS (all P<0.05). Infusion reactions were more prevalent in the transplant group (15.38% vs. 4.46%), whereas gastrointestinal reactions and hyperglycemia occurred more frequently in the conventional group.
CONCLUSION: Auto-HSCT with a rituximab-bendamustine conditioning regimen yields superior improvements in multi-organ lesions and long-term survival outcomes in patients with refractory SSc compared with conventional therapy, with a tolerable safety profile.
METHODS: This retrospective cohort study enrolled 216 patients with refractory SSc who received treatment between August 2019 and August 2023. Participants were divided into a transplant group (n=104) receiving the novel auto-HSCT regimen, and a conventional group (n=112) treated with prednisone combined with cyclophosphamide. Efficacy indicators, including the modified Rodnan skin score (mRSS), pulmonary, cardiac and renal function, organ involvement manifestations, autoantibody titers, quality of life (SF-36) scores, and clinical remission status, were assessed at baseline and 24 weeks post-treatment. Adverse events and progression-free survival (PFS) were also analyzed.
RESULTS: At the 24-week follow-up, the transplant group achieved significantly greater mRSS improvement (P<0.001). Significant improvements were also observed in pulmonary function (forced vital capacity [FVC], P=0.009) and cardiac function (left ventricular ejection fraction [LVEF], P=0.005) in the transplant group. The transplant group had a higher overall clinical remission rate (75.00% vs. 60.71%) and longer PFS (all P<0.05). Infusion reactions were more prevalent in the transplant group (15.38% vs. 4.46%), whereas gastrointestinal reactions and hyperglycemia occurred more frequently in the conventional group.
CONCLUSION: Auto-HSCT with a rituximab-bendamustine conditioning regimen yields superior improvements in multi-organ lesions and long-term survival outcomes in patients with refractory SSc compared with conventional therapy, with a tolerable safety profile.