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Comment & Response
June 21, 2016

Stem Cell Transplantation for Refractory Crohn Disease

Author Affiliations
  • 1Division of Immunotherapy, Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • 2Bone Transplantation Unit, Associação Portuguesa Beneficencia Hospital, São Paulo, Brazil
  • 3Kaiser Clinical Medical Center, São Paulo, Brazil
JAMA. 2016;315(23):2620. doi:10.1001/jama.2016.4030

To the Editor The Autologous Stem Cell Transplantation International Crohn Disease (ASTIC) trial by Dr Hawkey and colleagues1 was interpreted as a failure of autologous hematopoietic stem cell transplantation (HSCT) compared with standard care. However, the ASTIC trial used a complex multifaceted primary end point that included all of the following: Crohn disease activity index less than 150; no active treatment; and endoscopic and radiologic remission. This end point has not been used in any prior study. The data from such a small cohort of patients would have been interpreted as encouraging if the authors had used some of their secondary outcomes as the primary end point, for example, Crohn disease activity index change from baseline (P = .04) or simple endoscopic score of Crohn disease change from baseline (P = .03).