OC-007 Haemopoetic Stem Cell Transplantation For Severe Resistant Crohn’s Disease: Preliminary Evidence For Durable Benefit: Abstract OC-007 Table 1

Abstract

INTRODUCTION: The Autologous Stem Cell Transplantation International Crohn's Disease (ASTIC) Trial shows haemopoetic stem cell transplantation (HSCT) to be effective over one year in Crohn's disease, but its durability remains to be established. METHODS: ASTIC is a multicentre parallel group randomised controlled trial in patients with impaired quality of life due to Crohn's Disease that is resistant to established treatments. All patients undergo stem cell mobilisation before HSCT given immediately (one month: early HSCT) or after a delay of thirteen months (late HSCT). This abstracts describes currently available data over 2 years and includes the first report of changes occurring in the first year transplantation in the late HSCT group. RESULTS: A full analysis of progress over one year has shown a reduction in Crohn's Disease Activity Index (CDAI) from 326 (range 163-512) to 162 (12-506) and in the SES-CD endoscopic score from 13 (5-33) to 3 (0-200) in patients following early HSCT (n = 23) compared to 354 (91-581) to 298 (70-589, active vs control p = 0.01) and 13.5 (0-36) to 7 (1-27, active vs control p = 0.02) respectively in the control group prior to transplantation (n = 22). The Table shows data for those patients (approximately 50%) with full data currently available to two years (one year after transplantation in the control group). gutjnl;63/Suppl_1/A4-a/T1T1T1 Abstract OC-007 Table 1 CDAI (n = 12 and 14) SES-CD (n = 13 and 13) EQ5D VAS (n = 9 and 10) Early HSCT Late HSCT Early HSCT Late HSCT Early HSCT Late HSCT Baseline 338 (264-473) 354 (264-473) 13 (8.5-25) 14 (4.5-19.5) 56 (39-65) 35 (29-60) 1 year 162 (73-280)* 288 (209-368) 3 (1.5-10)* 6 (3-20) 80 (68-88)* 50 (21-70) 2 year 90 (36-231)* 155 (84-300)* 3 (0-10.5)* 2 (0-6.5)* 87 (64-91)* 74 (43-83)* Values shown are median and interquartile range. Asterisked data*: Post HSCT Scores for the IBD-Q quality of life index improved from 123 (103-144) to 165 (125-206) following early HSCT and were maintained at 157 (126-213). Scores rose from 108 (79-136) to 147 (108-188) in the year following delayed HSCT. CONCLUSION: If full data (available June 2014) confirm these preliminary results, it would support the notion that improvements in CDAI, endoscopic appearances and quality of life benefit persist and may possibly increase over the second year following transplantation. One year data in the delayed group show a similar magnitude of effect to that seen in patients undergoing early transplantation. DISCLOSURE OF INTEREST: None Declared.