A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease

Blood

Volumn 109, Issue 10, 2007, Pages 4557-4563

  Hockenbery, David M ^a,i   Cruickshank, Scott ^b   Rodell, Timothy C ^b   Gooley, Ted ^a   Schuening, Friedrich ^c   Rowley, Scott ^d   David, Donald ^e   Brunvand, Mark ^f   Berryman, Brian ^g   Abhyankar, Sunil ^h   Bouvier, Michelle ^a   McDonald, George B ^a  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b DOR BioPharma Inc   (United States)

^c VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^e CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^f Rocky Mountain Blood and Marrow Transplant Program   (United States)

^g Houston   (United States)

^h Oncol Hematol Assoc Kansas City   (United States)

ⁱ Fred Hutchinson Cancer Research Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE DIPROPIONATE; PLACEBO; PREDNISONE;

ADULT; ANOREXIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; ENDOCRINE FUNCTION; FEMALE; FOLLOW UP; GASTROINTESTINAL GRAFT VERSUS HOST DISEASE; GRAFT SURVIVAL; GRAFT VERSUS HOST REACTION; HUMAN; HYPOTHALAMUS HYPOPHYSIS ADRENAL SYSTEM; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RELAPSE; RISK ASSESSMENT; SIDE EFFECT; SURGICAL MORTALITY; SURVIVAL RATE; TREATMENT DURATION; TREATMENT FAILURE; VOMITING;

EID: 34248332633     PISSN: 00064971     EISSN: 00064971     Source Type: Journal    
DOI: 10.1182/blood-2006-05-021139     Document Type: Article

References (48)

1. Martin PJ, McDonald GB, Sanders JE, et al. Increasingly frequent diagnosis of acute graft-versus-host disease after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2004;10:320-327.
2. Hill GR, Ferrara JLM. The primacy of the gastrointestinal tract as a target organ of acute graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow transplantation. Blood. 2000;95:2754-2759.
3. Ferrara JLM, Antin JH. The Pathophysiology of Graft-vs.-Host Disease. In: Blume KG, Forman SJ, Appelbaum FR, eds. Thomas' Hematopoietic Cell Transplantation. 3rd ed. Malden, MA: Blackwell Publishing; 2004:353-368.
4. Sullivan KM. Graft versus host disease. In: Blume K, Forman SJ, Appelbaum F, eds. Thomas' Hematopoietic Cell Transplantation. 3rd ed. Malden, MA: Blackwell Publishing; 2004:635-664.
5. Spencer GD, Shulman HM, Myerson D, Thomas ED, McDonald GB. Diffuse intestinal ulceration after marrow transplantation: a clinical-pathological study of 13 patients. Hum Pathol. 1986;17:621-633.
6. Weisdorf SA, Salati LM, Longsdorf JA, Ramsay NK, Sharp HL. Graft-vs-host disease of the intestine: a protein-losing enteropathy characterized by fecal alpha1-antitrypsin. Gastroenterology. 1983;85:1076-1081.
7. Wu D, Hockenbery DM, Brentnall TA, et al. Persistent nausea and anorexia after marrow transplantation: a prospective study of 78 patients. Transplantation. 1998;66:1319-1324.
8. Strasser SI, McDonald GB. Gastrointestinal and hepatic complications. In: Blume K, Forman SJ, Appelbaum F, eds. Thomas' Hematopoietic Cell Transplantation. 3rd ed. Malden, MA: Blackwell Publishing; 2004:769-810.
9. Murai M, Yoneyama H, Ezaki T, et al. Peyer's patch is the essential site in initiating murine acute and lethal graft-versus-host reaction. Nat Immunol. 2003;4:154-160.
10. Van Lint MT, Milone G, Leotta S, et al. Treatment of acute graft-versus-host disease with prednisolone: significant survival advantage for day +5 responders and no advantage for nonresponders receiving anti-thymocyte globulin. Blood. 2006;107:4177-4181.
11. McDonald GB, Bouvier M, Hockenbery DM, et al. Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial. Gastroenterology. 1998;115:28-35.
12. Washington K, Bentley RC, Green A, Olson J, Treem KR, Krigman HK. Gastric graft-versus-host disease: a blinded histologic study. Am J Surg Pathol. 1997;21:1037-1046.
13. Ponec RJ, Hackman RC, McDonald GB. Endoscopic and histologic diagnosis of intestinal graft-vs.-host disease after marrow transplantation. Gastrointest Endosc. 1999;49:612-621.
14. Cox GJ, Matsui SM, Lo RS, et al. Etiology and outcome of diarrhea after marrow transplantation: a prospective study. Gastroenterology. 1994;107:1398-1407.
15. Hackman RC, Wolford JL, Gleaves CA, et al. Recognition and rapid diagnosis of upper gastrointestinal cytomegalovirus infection in marrow transplant recipients: a comparison of seven virologic methods. Transplantation. 1994;57:231-237.
16. Collett, D. Modeling Survival Data in Medical Research. Boca Raton, FL: Chapman and Hall; 2003.
17. Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. New York, NY: Springer; 2000.
18. SAS user's guide: statistics. Version 8. Cary, NC: SAS Institute; 1999.
19. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2004.
20. Martin PJ, Schoch G, Fisher L, et al. A retrospective analysis of therapy for acute graft-versus-host disease: initial treatment. Blood. 1990;76:1464-1472.
21. Martin PJ, Schoch G, Fisher L, et al. A retrospective analysis of therapy for acute graft-versus-host disease: secondary treatment. Blood. 1991;77:1821-1828.
22. McDonald GB, Sale GE. The human gastrointestinal tract after allogenic marrow transplantation. In: Sale GE, Shulman HM, eds. The Pathology of Bone Marrow Transplantation. New York, NY: Masson; 1984:77-103.
23. Diaconescu R, Flowers CR, Storer B, et al. Morbidity and mortality with nonmyeloablative compared with myeloablative conditioning before hematopoietic cell transplantation from HLA-matched related donors. Blood. 2004;104:1550-1558.
24. Brogden RN, Pinder RM, Sawyer PR, Speight TM, Avery GS. Beclomethasone dipropionate inhaler: a review of its pharmacology, therapeutic value and adverse effects, I: asthma. Drugs. 1975;10:166-210.
25. Levine DS. Immune modulating therapies for idiopathic inflammatory bowel disease. Adv Pharmacol. 1994;25:171-234.
26. Lofberg R, Ostergaard Thomsen O, Langholz E, et al. Budesonide versus prednisolone retention enemas in active distal ulcerative colitis. Aliment Pharmacol Ther. 1994;8:623-629.
27. Rutgeerts P, Lofberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med. 1994;331:842-845.
28. Adams NP, Bestall JB, Malouf R, Lasserson TJ, Jones PW. Inhaled beclomethasone versus placebo for chronic asthma. Cochrane Database Syst Rev. 2005;1.
29. Lofberg R, Rutgeerts P, Malchow H, et al. Budesonide prolongs time to relapse in ileal and ileocaecal Crohn's disease: a placebo controlled one year study. Gut. 1996;39:82-86.
30. Levine DS, Raisys VA, Ainardi V. Coating of oral beclomethasone dipropionate capsules with cellulose acetate phthalate enhances delivery of topically active antiinflammatory drug to the terminal ileum. Gastroenterology. 1987;92:1037-1044.
31. Baehr PH, Levine DS, Bouvier ME, et al. Oral beclomethasone dipropionate for treatment of human intestinal graft-versus-host disease. Transplantation. 1995;60:1231-1238.
32. Harris DM. Properties and therapeutic uses of some corticosteroids with enhanced topical potency. J Steroid Biochem. 1975;6:711-716.
33. Wurthwein G, Rehder S, Rohdewald P. Lipophilicity and receptor affinity of glucocorticoids. Pharm Ztg Wiss. 1992;137:161-167.
34. Daley-Yates PT, Price AC, Sisson JR, Pereira A, Dallow N. Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol. 2001;51:400-409.
35. Hakki M, Riddell SR, Storek J, et al. Immune reconstitution to cytomegalovirus after allogeneic hematopoietic stem cell transplantation: impact of host factors, drug therapy, and subclinical reactivation. Blood. 2003;102:3060-3067.
36. Nichols WG, Corey L, Gooley T, et al. Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes. Blood. 2001;97:867-874.
37. Marr KA, Carter RA, Boeckh M, Martin P, Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002;100:4358-4366.
38. Fukuda T, Boeckh M, Carter RA, et al. Risks and outcomes of invasive fungal infections in recipients of allogeneic hematopoietic stem cell transplants after nonmyeloablative conditioning. Blood. 2003;102:827-833.
39. Narimatsu H, Matsumura T, Kami M, et al. Bloodstream infection after umbilical cord blood transplantation using reduced-intensity stem cell transplantation for adult patients. Biol Blood Marrow Transplant. 2005;11:429-436.
40. Woltman AM, de Fijter JW, Kamerling SW, Paul LC, Daha MR, van Kooten C. The effect of calcineurin inhibitors and corticosteroids on the differentiation of human dendritic cells. Eur J Immunol. 2000;30:1807-1812.
41. Rea D, van Kooten C, van Meijgaarden KE, Ottenhoff TH, Melief CJ, Offringa R. Glucocorticoids transform CD40-triggering of dendritic cells into an alternative activation pathway resulting in antigen-presenting cells that secrete IL-10. Blood. 2000;95:3162-3167.
42. Salzman GA, Pyszczynski DR. Oropharyngeal candidiasis in patients treated with beclomethasone dipropionate delivered by metered dose inhaler alone and with Aerochamber. J Allergy Clin Immunol. 1988;81:424-428.
43. Kesten S, Hyland RH, Pruzanski WR, Kortan PP. Esophageal candidiasis associated with beclomethasone dipropionate aerosol therapy. Drug Intell Clin Pharm. 1988;22:568-569.
44. Harris DM, Martin LE, Harrison C, Jack D. The effect of oral and inhaled beclomethasone dipropionate on adrenal function. Clin Allergy. 1973;3:243-248.
45. Iyer RV, Hahn T, Roy HN, et al. Long-term use of oral beclomethasone dipropionate for the treatment of gastrointestinal graft-versus-host disease. Biol Blood Marrow Transplant. 2005;11:587-592.
46. Rizzello F, Gionchetti P, Galeazzi R, et al. Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis: a dose-finding study. Adv Ther. 2001;18:261-271.
47. Rizzello F, Gionchetti P, D'Arienzo A, et al. Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2002;16:1109-1116.
48. Rautiainen H, Karkkainen P, Karvonen AL, et al. Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: a threeyear randomized trial. Hepatology. 2005;41:747-752.