title: Long-term use of oral beclomethasone dipropionate for the treatment of gastrointestinal graft-versus-host disease.
abstract: Treatment of severe acute and chronic gastrointestinal (GI) graft-versus-host disease (GVHD) with prolonged high-dose systemic corticosteroids has limited success and considerable toxicity. Beclomethasone dipropionate (BDP) is a potent topically active steroid. We treated 15 patients with acute (n = 2) or chronic (n = 13) GI GVHD refractory to systemic corticosteroids with 28-day courses of oral BDP (2 mg 4 times daily). Response was measured by the change in GI score (sum of 6 GI symptoms) as well as the ability to taper or discontinue systemic corticosteroids. Nine (60%) of 15 evaluable patients responded to BDP, including 3 complete responses (a GI score of 0 or 1 and discontinuation of systemic corticosteroids). Attempts to taper calcineurin inhibitor during BDP therapy were unsuccessful. The 2 patients with acute GVHD had no response to BDP. Responders received a median of 3 cycles (range, 1-20), compared with 1 cycle (range, 1-5) in nonresponders. Suppression of the hypothalamic-adrenal axis was seen in 2 of the 5 patients tested, but neither demonstrated clinically significant symptoms. We conclude that BDP is safe and effective for long-term treatment of chronic GI GVHD. Multiple courses may be necessary to achieve or maintain response in some patients, and prolonged BDP therapy is a feasible alternative to prolonged systemic corticosteroids.
authors.affiliation: Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA. renuka.iyer@roswellpark.org
authors.forename: Renuka V
authors.initials: RV
authors.lastname: Iyer
authors.forename: Theresa
authors.initials: T
authors.lastname: Hahn
authors.forename: Hilary N
authors.initials: HN
authors.lastname: Roy
authors.forename: Minoo
authors.initials: M
authors.lastname: Battiwalla
authors.forename: Mary
authors.initials: M
authors.lastname: Cooper
authors.forename: Barbara
authors.initials: B
authors.lastname: Anderson
authors.forename: Pam
authors.initials: P
authors.lastname: Paplham
authors.forename: Karen
authors.initials: K
authors.lastname: Brown
authors.forename: Barbara
authors.initials: B
authors.lastname: Bambach
authors.forename: Brahm H
authors.initials: BH
authors.lastname: Segal
authors.forename: Philip L
authors.initials: PL
authors.lastname: McCarthy
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D005260:Female; D005767:Gastrointestinal Diseases / Q000150:complications / Q000188:drug therapy*; D006086:Graft vs Host Disease / Q000150:complications / Q000188:drug therapy*; D006402:Hematologic Diseases / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D033581:Stem Cell Transplantation; D013995:Time
chemical_list: D000893:Anti-Inflammatory Agents; D001507:Beclomethasone