title: Oral beclomethasone dipropionate: a topically active corticosteroid for the treatment of gastrointestinal graft-versus-host disease following allogeneic hematopoietic cell transplantation.
abstract: Beclomethasone dipropionate (BDP) is a topically active anti-inflammatory corticosteroid. Oral BDP is metabolized in the intestine to a potent metabolite, 17-beclomethasone monopropionate (17-BMP). An oral formulation (orBec; DOR BioPharma), consisting of a gastric release and an enteric-coated pill, was studied in patients with acute gastrointestinal graft-versus-host disease, an inflammatory disorder that is common after allogeneic hematopoietic cell transplantation. Randomized trials demonstrated that orBec is safe and effective in treating acute gastrointestinal graft-versus-host disease (GVHD) when used with a short induction course of prednisone, reducing the risk of GVHD treatment failure by > 60% and reducing mortality 1 year after randomization by 45%, with fewer deaths due to infection and recurrent malignancy. The type of conditioning and the type of donor had no effect on the frequency of GVHD treatment failure during the 80-day study period; the greatest benefit in terms of survival was among patients who had received reduced-intensity conditioning therapy and among those who received a graft from other than a human leukocyte antigen-matched sibling. orBec controls the intestinal inflammatory process of GVHD and avoids prolonged exposure to prednisone, which is the present standard of care. Oral BDP is the only therapy to be studied in the last 30 years to effectively treat acute GVHD and reduce mortality.
authors.affiliation: University of Washington School of Medicine, Gastroenterology/Hepatology Section (D2-190), Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, Seattle, WA 98109-1024, USA.
authors.forename: George B
authors.initials: GB
authors.lastname: McDonald
mesh_terms: D000818:Animals; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001507:Beclomethasone / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D041981:Gastrointestinal Tract; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D014184:Transplantation, Homologous
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D001507:Beclomethasone