Budesonide for Engraftment Fever Prophylaxis: A Single Center Randomized Study Interim Analysis

Document Type

Conference Proceeding

Publication Date

2-1-2025

Publication Title

Transplant Cell Ther

Keywords

budesonide, steroid, acute leukemia, adult, African American, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, Caucasian, clinical article, complication, conference abstract, controlled study, diagnosis, engraftment, engraftment syndrome, female, fever, Hispanic, hospitalization, human, incidence, length of stay, male, multiple myeloma, neutrophil, prevention, prophylaxis, prospective study, randomized controlled trial, therapy

Abstract

Background: Engraftment Syndrome (ES) is an early complication post HSCT that may occur around neutrophil recovery day +7-21. Its incidence varies widely (7 to 72%) depending on the criteria used. The mechanism is not completely understood, but it is suggested that it is related to reactive lymphocytes driven by cytokines. ES is usually a self-limited process but is associated with increased length of hospitalization. Prior studies by Dhakal et al. and three other studies have demonstrated the benefit of steroid prophylaxis in reducing ES. Since there are no randomized data regarding interventions to prevent ES, we conducted a prospective study to determine if budesonide prophylaxis starting on day +5 post HSCT reduces the incidence of engraftment fever and or ES. Methods: This is a prospective, single center, open-label, randomized trial in patients aged 18 years and older receiving allogenic or autologous HSCT at Henry Ford Health in the United States. We randomly assigned patients (1:1) to receive budesonide 3 mg or nothing orally starting 5 days post SCT until neutrophil engraftment (twice a week for allogeneic and daily for autologous HSCT). Primary outcome is to assess the incidence of engraftment fever between the two groups. Secondary outcomes include to determine severity of ES between the two groups and length of stay (LOS). Results: Between December 13, 2023, and August 29, 2024, 52 consecutive patients were randomly assigned to receive budesonide (n=30) or nothing (n=22). Thirty were males and 22 females, with many patients Caucasians (n=33), followed by African American (n=12), others (n=6), and Hispanic (1). Autologous HCT was performed in 34 patients, whereas 18 patients underwent an allogeneic HCT. Multiple Myeloma was the primary diagnosis for patients undergoing and autologous HCT and Acute Leukemia was the primary diagnosis in allogeneic HCT. Of the 22 patients who did not receive budesonide (12 auto and 10 allo HSCT), 18 experienced a fever with 3 who had positive cultures. Of the 30 who were assigned to budesonide, 19 experienced fevers with 2 positive cultures. There was a trend for patients receiving budesonide prophylaxis to experience fewer fevers than those in the non-budesonide group, regardless of whether the transplant was autologous or allogeneic (OR for the whole group was 0.38 (p=0.15), auto HSCT 0.2 (p=0.21), allo HSCT 0.3 (p=0.18). None of the patients experience a related or probably related severe adverse event related to budesonide. Conclusion: At this point, in this interim analysis, there seems to be a trend for less fever with budesonide without severe adverse events. Nothing is statistically significant so far.

Volume

31

Issue

2

First Page

S545

Last Page

S546

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