Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial

Lindsay, James O.; Clark, Miranda; Allez, Mathieu; Labopin, Myriam; Rogler, Gerhard; Rovira, Montserrat; Satsangi, Jack; Farge, Dominique; Hawkey, Christopher J.; Ricart, Elenor

Abstract

Background: The randomised controlled ASTIC trial showed no benefit of mobilisation and autologous haematopoietic stem-cell transplantation (HSCT) compared with mobilisation followed by conventional therapy using a stringent primary endpoint (steroid-free clinical remission for 3 months with no endoscopic or radiological evidence of intestinal inflammation) in patients with treatment-refractory Crohn's disease. We now assess HSCT in patients enrolled in the ASTIC trial using endpoints that are traditional for clinical trials in Crohn's disease, and identify factors that predict benefit or harm.

Methods: Patients who underwent mobilisation and were randomly assigned to conventional therapy in the ASTIC trial were offered HSCT at 1 year and underwent complete assessment for a further year. We report analyses of the combined cohort of patients who underwent HSCT at any time during the ASTIC trial programme. The primary outcome for this analysis was 3-month steroid-free clinical remission at 1 year after HSCT (Crohn's Disease Activity Index [CDAI]

Citation

Lindsay, J. O., Clark, M., Allez, M., Labopin, M., Rogler, G., Rovira, M., …Ricart, E. (2017). Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial. Lancet Gastroenterology and Hepatology, 2(6), 399-406. https://doi.org/10.1016/S2468-1253%2817%2930056-0

• Journal Article Type: Article
• Acceptance Date: Feb 8, 2017
• Online Publication Date: Apr 6, 2017
• Publication Date: Jun 1, 2017
• Deposit Date: Nov 23, 2017
• Publicly Available Date: Aug 15, 2019
• Journal: The Lancet Gastroenterology & Hepatology
• Print ISSN: 2468-1253
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 2
• Issue: 6
• Pages: 399-406
• DOI: https://doi.org/10.1016/S2468-1253%2817%2930056-0
• Public URL: http://www.sciencedirect.com/science/article/pii/S2468125317300560
• Publisher URL: https://www.sciencedirect.com/science/article/abs/pii/S2468125317300560?via%3Dihub