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An international study reports 60% progression-free survival at 10 years after autologous bone marrow transplantation, adding evidence of sustained positive clinical outcomes and long-term safety in patients treated for early severe systemic sclerosis.

Systemic sclerosis is a rare chronic and heterogeneous autoimmune disease characterized by progressive fibrosis of the skin and internal organs, with severe forms associated with high morbidity and mortality.

Autologous hematopoietic cell transplantation (HCT) is an established treatment option (grade A level of evidence) for carefully selected patients with early diffuse severe disease, supported by randomized clinical trials. However, very long-term evidence on outcomes approaching a decade has remained limited.

The NISSC1-LTE study conducted by the Autoimmune Diseases Working Party of EBMT is the first international prospective study providing long-term results on autologous HCT in patients with early severe systemic sclerosis. Published in The Lancet Rheumatology, the study followed 80 patients for a median of 9.2 years after transplantation.

NISSC1-LTE extends the original prospective EBMT NISSC1 study, drawing on follow-up data from 13 participating centers in France, Germany, the Netherlands, Italy, Spain, Switzerland and Brazil.

The EBMT-NISSC1 cohort comprised patients who underwent their first autologous HCT for severe progressive systemic sclerosis between 2012 and 2016. The findings provide evidence of sustained disease control and the long-term risks of treatment.

At 10 years, estimated progression-free survival was 60% (95% CI, 47%–71%) and overall survival was 71% (56%–82%).

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