High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study

Blood. 2007 Aug 15;110(4):1388-96. doi: 10.1182/blood-2007-02-072389. Epub 2007 Apr 23.

Abstract

More effective therapeutic strategies are required for patients with poor-prognosis systemic sclerosis (SSc). A phase 2 single-arm study of high-dose immunosuppressive therapy (HDIT) and autologous CD34-selected hematopoietic cell transplantation (HCT) was conducted in 34 patients with diffuse cutaneous SSc. HDIT included total body irradiation (800 cGy) with lung shielding, cyclophosphamide (120 mg/kg), and equine antithymocyte globulin (90 mg/kg). Neutrophil and platelet counts were recovered by 9 (range, 7 to 13) and 11 (range, 7 to 25) days after HCT, respectively. Seventeen of 27 (63%) evaluable patients who survived at least 1 year after HDIT had sustained responses at a median follow-up of 4 (range, 1 to 8) years. There was a major improvement in skin (modified Rodnan skin score, -22.08; P < .001) and overall function (modified Health Assessment Questionnaire Disability Index, -1.03; P < .001) at final evaluation. Importantly, for the first time, biopsies confirmed a statistically significant decrease of dermal fibrosis compared with baseline (P < .001). Lung, heart, and kidney function, in general, remained clinically stable. There were 12 deaths during the study (transplantation-related, 8; SSc-related, 4). The estimated progression-free survival was 64% at 5 years. Sustained responses including a decrease in dermal fibrosis were observed exceeding those previously reported with other therapies. HDIT and autologous HCT for SSc should be evaluated in a randomized clinical trial.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Antigens, CD34 / metabolism
  • Antilymphocyte Serum / administration & dosage*
  • Combined Modality Therapy
  • Cyclophosphamide / administration & dosage*
  • Female
  • Fibrosis / chemically induced
  • Fibrosis / drug therapy
  • Fibrosis / prevention & control
  • Follow-Up Studies
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Hematopoietic Stem Cell Mobilization
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Pilot Projects
  • Scleroderma, Systemic / immunology
  • Scleroderma, Systemic / therapy*
  • Skin / drug effects
  • Skin / metabolism
  • Skin / pathology
  • Survival Rate
  • Transplantation, Autologous
  • Whole-Body Irradiation

Substances

  • Antigens, CD34
  • Antilymphocyte Serum
  • Immunosuppressive Agents
  • Granulocyte Colony-Stimulating Factor
  • Cyclophosphamide