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Comment & Response |

Stem Cell Transplantation for Refractory Crohn Disease

Richard K. Burt, MD1; Milton A. Ruiz, MD, PhD2; Roberto L. Kaiser Jr, MD, PhD3
[+] 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.
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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).

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June 21, 2016
Christopher J. Hawkey, FMedSci; James Lindsay, PhD; John Gribben, MD
1Nottingham Digestive Diseases Center, University of Nottingham, Nottingham, United Kingdom
2Blizard Institute, Barts and the London School of Medicine, London, United Kingdom
3Barts Cancer Institute, Barts and the London School of Medicine, London, United Kingdom
JAMA. 2016;315(23):2620-2621. doi:10.1001/jama.2016.4033.
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