title: Oral beclomethasone dipropionate for the treatment of gastrointestinal chronic graft-versus-host disease.
abstract: The most common approach for the treatment of chronic graft-versus-host disease (cGVHD) has been the long-term use of systemic steroids. Beclomethasone dipropionate (BDP) is a topically active corticosteroid with relatively low absorption from the gastrointestinal mucosa. It has been successfully used to treat acute GVHD (aGVHD), but its use in the cGVHD setting is far more limited. In the current study, BDP was administered to 33 patients who underwent allogeneic transplantation and had biopsy-proven gastrointestinal cGVHD (GI cGVHD). Twenty-six patients with GI cGVHD received BDP as first-line and 7 as either second- or third-line treatment. All patients received BDP together with a calcineurin inhibitor, except for 1 patient who was also receiving mycophenolate mofetil (MMF). BDP was administered for a minimum of 16 weeks and was tapered during 4 additional weeks. Of those patients receiving BDP as the first line of treatment, 22 (84.6%) achieved complete remission (CR) of GI cGVHD, 2 (7.7%) achieved a partial response (PR) and 2 (7.7%) did not respond or progressed. Median time to response was 28 days. Nevertheless, only 7 (27%) patients had maintained the response at last follow-up, whereas 19 (73%) finally relapsed or progressed. Median time to relapse was 147 days after the end of BDP. In the case of the patients who received BDP as a second- or third-line treatment, 3 (42.9%) achieved CR and 2 (28.6%) PR. For the whole series of patients, 13 patients (39.4%) were not receiving immunosuppressive treatment at final follow-up. Only 4 patients developed cytomegalovirus (CMV) reactivation, which was successfully treated with antiviral drugs. No fungal infection was observed during the treatment period. In conclusion, the current study shows that BDP, in the absence of systemic steroids, is a highly effective initial therapeutic approach for GI cGVHD, which helps to avoid complications related to systemic steroids.
authors.affiliation: Servicio de Hematología, Hospital Clínico Universitario de Salamanca y Centro de Investigación del Cáncer, Centro en Red de Medicina Regenerativa y Terapia Celular de Castilla y Leon, Salamanca, Spain.
authors.forename: Fernanda N
authors.initials: FN
authors.lastname: Villanueva
authors.forename: Jose Antonio
authors.initials: JA
authors.lastname: Pérez-Simón
authors.forename: Fernando F
authors.initials: FF
authors.lastname: Silva
authors.forename: Teresa T
authors.initials: TT
authors.lastname: Caballero-Velázquez
authors.forename: Fermin F
authors.initials: FF
authors.lastname: Sánchez-Guijo
authors.forename: Conzuelo C
authors.initials: CC
authors.lastname: Cañizo
authors.forename: Lourdes L
authors.initials: LL
authors.lastname: Vázquez
authors.forename: Dolores D
authors.initials: DD
authors.lastname: Caballero
authors.forename: Jesús F
authors.initials: JF
authors.lastname: San Miguel
mesh_terms: D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001507:Beclomethasone / Q000008:administration & dosage*; D001706:Biopsy; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000473:pathology; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000473:pathology; D019337:Hematologic Neoplasms / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D036102:Peripheral Blood Stem Cell Transplantation; D014184:Transplantation, Homologous
chemical_list: D000893:Anti-Inflammatory Agents; D009173:Mycophenolic Acid; D001507:Beclomethasone