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Myeloablative Autologous Stem-Cell Transplantation for Severe Scleroderma.

Keith M Sullivan1, Ellen A Goldmuntz1, Lynette Keyes-Elstein1

  • 1From the Duke University Medical Center (K.M.S., O.C., E.W.S.C.) and RTI International (D.W.), Durham, and Rho Federal Systems Division, Chapel Hill (L.K.-E., A.P., B.E., S.C.) - all in North Carolina; National Institute of Allergy and Infectious Diseases, Bethesda, MD (E.A.G., B.W., L.M.G., J.S.G.); Colorado Blood Cancer Institute, Denver (P.A.M., R.A.N.); University of Texas McGovern Medical School (M.D.M.) and M.D. Anderson Cancer Center (C.H.) - both in Houston; Vanderbilt University, Nashville (L.J.C., K.P.); University of Michigan, Ann Arbor (D.K., J.R.S.); Case Western Reserve University and University Hospitals, Cleveland (R.J.F.); University of Alabama, Birmingham (S.M.); Boston University, Boston (R.W.S.); University of Virginia, Charlottesville (K.B.); University of Washington (M.H.W., D.E.F.) and the Fred Hutchinson Cancer Research Center (G.E.G., S.H.) - both in Seattle; University of California, Los Angeles, Los Angeles (J.G., S.K., D.E.F.); City of Hope National Medical Center, Duarte, CA (S.F.); Medical University of South Carolina, Charleston (R.M.S.); Mayo Clinic, Scottsdale, AZ (L.G.); University of Calgary, Calgary, AB, Canada (J.S., S.L.); Washington University, St. Louis (R.B.); Medical College of Wisconsin, Milwaukee (M.E.C., C.K.-T.); Ottawa Hospital Research Institute, Ottawa (C.B.); University of Pittsburgh, Pittsburgh (T.M., R.T.D.); and University of Toledo Medical Center, Toledo, OH (M.B.K.).

The New England Journal of Medicine
|January 4, 2018
PubMed
Summary

Myeloablative autologous stem-cell transplantation offers significant long-term survival benefits for severe scleroderma patients compared to cyclophosphamide. While toxicity is higher, it leads to fewer patients needing disease-modifying antirheumatic drugs.

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Area of Science:

  • Hematology
  • Immunology
  • Rheumatology

Background:

  • Diffuse cutaneous systemic sclerosis (scleroderma) often leads to poor outcomes despite existing treatments.
  • Autologous hematopoietic stem-cell transplantation (HSCT) is being explored as a potential therapy.

Purpose of the Study:

  • To compare the efficacy and safety of myeloablative autologous HSCT versus monthly cyclophosphamide infusions in severe scleroderma patients.

Main Methods:

  • Randomized trial comparing myeloablative autologous HSCT (36 participants) with cyclophosphamide (39 participants) in adults aged 18-69 with severe scleroderma.
  • Primary endpoint assessed at 54 months using a global rank composite score including survival, event-free survival, forced vital capacity, and skin/disability scores.

Main Results:

  • Transplantation demonstrated superiority in the global rank composite score (P=0.01) and event-free survival at 54 months (79% vs. 50%, P=0.02).
  • At 72 months, transplantation showed improved event-free (74% vs. 47%) and overall survival (86% vs. 51%) (P=0.03 and P=0.02, respectively).
  • Fewer transplant recipients required disease-modifying antirheumatic drugs (DMARDs) (9% vs. 44%, P=0.001), though treatment-related mortality was 6% at 72 months.

Conclusions:

  • Myeloablative autologous HSCT provides sustained long-term benefits for scleroderma patients, including enhanced survival.
  • The observed toxicity and treatment-related mortality were within expected ranges and lower than some previous reports.
  • This approach represents a viable option for severe scleroderma, warranting further investigation into risk-benefit profiles.