Budesonide for Engraftment Fever Prophylaxis following Autologous vs. Allogeneic Hematopoietic Stem Cell Transplantation: An Interim Analysis

Background: Engraftment Syndrome (ES), an inflammatory process involving fever and rash, has been observed to be a frequent complication following autologous hematopoietic stem cell transplantation (HSCT); however, there is limited data on its incidence after allogeneic HSCT. Studies by Betticher et al. and others have illustrated the role of steroids in reducing ES. Due to a lack of randomized trials exploring prophylactic measures, we conducted a prospective study to establish whether there is a difference between autologous vs. allogeneic groups with respect to budesonide prophylaxis and reduction of ES. Methods: This randomized trial is based on 56 patients who received allogeneic (n=18) or autologous (n=38) HSCT at Henry Ford Health. Patients were randomly assigned to receive either budesonide 3mg (n=30) or no prophylaxis (n=26) starting 5 days after the procedure until neutrophil engraftment. Aim is assessing difference of ES between the two groups. Results: In the intention to treat analysis, among the autologous group, of the 22 patients who received budesonide, 16 experienced fevers, and of the 16 non-budesonide patients, 12 experienced fevers. In the allogeneic group, of the 8 patients who received budesonide, 3 experienced fevers, and of the 10 non-budesonide patients, 7 experienced fevers. There was a trend for patients receiving budesonide to experience fewer fevers, however, there is no statistically significant difference between the autologous and allogeneic groups in terms of fever incidence (p=0.104). Conclusion: In this interim analysis, ES incidence in patients on budesonide did not show a statistical significance between autologous and allogeneic HSCT patients.