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25 June 2014

New Results show that Autologous HSCT increases survival rate in patients with diffuse cutaneous systemic sclerosis

Final results from the Autologous Stem Cell Transplantation International Scleroderma (ASTIS) trial published in the Journal of the American Medical Association (JAMA) on June 25th 2014 evidence that autologous haematopoietic stem cell transplantation (HSCT) confers better long term survival than 12 monthly intravenous pulses of cyclophosphamide treatment for diffuse cutaneous sclerosis.

From March 2001 to October 2009, 156 patients from 10 countries with early diffuse cutaneous systemic sclerosis were recruited and followed up until the end of October 2013. After registration, patients were randomly assigned to receive HSCT or monthly intravenous pulses of cyclophosphamide with the aim to compare survival rates of both treatments. The primary end point of ASTIS was event-free survival, defined as time from randomization until the occurrence of death or persistent major organ failure.

ASTIS trial is an international, multi-centre, investigator-based, open label, phase III trial that involved 29 centers. It is a unique groundbreaking academic collaborative project coordinated by two leading entities in the fields of the study, the European Society for Blood and Marrow Transplantation (EBMT) and the European League Against Rheumatism (EULAR).

Even though HSCT therapy shows more treatment-related mortality in early stages of the follow up, long term event-free and overall survival rates are higher in the HSCT treatment group than in the control group. In a post-hoc analysis, the difference was greater in non-smoking patients. “These results are very encouraging and shed light on new research on the type of patient that will benefit from immunosuppressive therapy” said Professor Jaap van Laar (UMC Utrecht) and Professor Dominique Farge Bancel (Assistance Publique Hôpitaux  de Paris) with Alan Tyndall (Basel University) and other co-authors.


Systemic sclerosis is a rare heterogeneous autoimmune connective disease tissue disease characterized by vasculopathy, autoantibody formation, low-grade inflammation, and fibrosis in skin and internal organs. It affects 2-22 people per one million every year and the diffuse cutaneous form of the condition – which is a more severe form of the disease - makes up to 30% of the total cases. This severe autoimmune disease can lead to premature death by lung fibrosis and pulmonary hypertension with no curative treatment yet discovered.

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