Oral beclomethasone dipropionate: a topically active corticosteroid for the treatment of gastrointestinal graft-versus-host disease following allogeneic hematopoietic cell transplantation

Bibliography

• 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.
   PubMed Web of Science ®Google Scholar
• HOLMBERG L, KIKUCHI K, GOOLEY TA et al.: Gastrointestinal graft-versus-host disease in recipients of autologous hematopoietic stem cells: incidence, risk factors, and outcome. Biol. Blood Marrow Transplant. (2006) 12:226-234.
   PubMed Web of Science ®Google Scholar
• ADAMS KM, HOLMBERG LA, LEISENRING W et al.: Risk factors for syngeneic graft-versus-host disease after adult hematopoietic cell transplantation. Blood (2004) 104:1894-1897.
   PubMed Web of Science ®Google Scholar
• SULLIVAN KM: Graft versus host disease. In: Thomas' Hematopoietic Cell Transplantation (3rd Edition). Blume K, Forman SJ, Appelbaum F (Eds), Blackwell Publishing, Inc., Malden, USA (2004):635-664.
   Google Scholar
• STRASSER SI, MCDONALD GB: Gastrointestinal and hepatic complications. In: Thomas' Hematopoietic Cell Transplantation (3rd Edition). Blume K, Forman SJ, Appelbaum F (Eds), Blackwell Publishing, Inc., Malden, USA (2004):769-810.
   Google Scholar
• FERRARA JLM, ANTIN JH: The pathophysiology of graft-vs.-host disease. In: Thomas' Hematopoietic Cell Transplantation (3rd Edition), Blume KG, Forman SJ, Appelbaum FR (Eds), Blackwell Publishing, Inc., Malden, MA, USA (2004):353-368.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• JANIN A, ERTAULT-DANESHPOUY M, SOCIE G: Eosinophils and severe forms of graft-versus-host disease. Blood (2003) 101:2073.
   PubMed Web of Science ®Google Scholar
• SOCIE G, MARY J-Y, LEMANN M et al.: Prognostic value of apoptotic cells and infiltrating neutrophils in graft-versus-host disease of the gastrointestinal tract in humans: TNF and Fas expression. Blood (2004) 103:50-57.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• GLUCKSBERG H, STORB R, FEFER A et al.: Clinical manifestations of graft-versus-host disease in human recipients of marrow from HL-A-matched sibling donors. Transplantation (1974) 18:295-304.
   PubMed Web of Science ®Google Scholar
• PRZEPIORKA D, WEISDORF D, MARTIN P et al.: 1994 Consensus conference on acute GVHD grading. Bone Marrow Transplant. (1995) 15:825-828.
   PubMed Web of Science ®Google Scholar
• ROWLINGS PA, PRZEPIORKA D, KLEIN JP et al.: IBMTR severity index for grading acute graft-versus-host disease: retrospective comparison with Glucksberg grade. Br. J. Haematol. (1997) 97:855-864.
   PubMed Web of Science ®Google Scholar
• PARRISH RS, HAZLETT LJ, BRIDGES KD, HENSLEE-DOWNEY PJ: A multivariate approach for assessing severity of acute graft-versus-host disease in bone marrow transplantation. Stat. Med. (1999) 18:423-440.
   PubMed Web of Science ®Google Scholar
• MARTIN P, NASH R, SANDERS J et al.: Reproducibility in retrospective grading of acute graft-versus-host disease after allogeneic marrow transplantation. Bone Marrow Transplant. (1998) 21:273-279.
   PubMed Web of Science ®Google Scholar
• AL-GHAMDI H, LEISENRING W, BENSINGER WI et al.: A proposed objective way to assess results of randomized prospective clinical trials with acute graft-versus-host disease as an outcome of interest. Br. J. Haematol. (2001) 113:461-469.
   PubMed Web of Science ®Google Scholar
• MARTIN PJ, SCHOCH G, GOOLEY T et al.: Methods for assessment of graft-versus-host disease. Blood (1998) 92:3479-3481.
   PubMed Web of Science ®Google Scholar
• CAHN JY, KLEIN JP, LEE SJ et al.: Prospective evaluation of 2 acute graft-versus-host (GVHD) grading systems: a joint Societe Francaise de Greffe de Moelle et Therapie Cellulaire (SFGM-TC), Dana Farber Cancer Institute (DFCI), and international bone marrow transplant registry (IBMTR) prospective study. Blood (2005) 106:1495-1500.
   PubMed Web of Science ®Google Scholar
• LEISENRING W, MARTIN P, PETERSDORF E et al.: An acute graft-versus-host disease activity index to predict survival after hematopoietic cell transplantation with myeloablative conditioning regimens. Blood (2006) 108:749-755.
   PubMed Web of Science ®Google Scholar
• BUTTGEREIT F, BURMESTER G-R, LIPWORTH BJ: Optimised glucocorticoid therapy: the sharpening of an old spear. Lancet (2005) 365:801-803.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• LEVINE DS: Immune modulating therapies for idiopathic inflammatory bowel disease. Adv. Pharmacol. (1994) 25:171-234.
   PubMedGoogle Scholar
• 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.
   Google Scholar
• ADAMS NP, BESTALL JB, MALOUF R, LASSERSON TJ, JONES PW: Inhaled beclomethasone versus placebo for chronic asthma. Cochrane Database Syst. Rev. (2005) 1:CD002738.
   Google Scholar
• BOUMPAS DT, PALIOGIANNI F, ANASTASSIOU ED, BALOW JE: Glucocorticosteroid action on the immune system: molecular and cellular aspects. Clin. Exp. Rheumatol. (1991) 9:413-423.
   PubMed Web of Science ®Google Scholar
• CATO AC, WADE E: Molecular mechanisms of anti-inflammatory action of glucocorticoids. Bioessays (1996) 18:371-378.
   PubMed Web of Science ®Google Scholar
• FRANCHIMONT D: Overview of the actions of glucocorticoids on the immune response: a good model to characterize new pathways of immunosuppression for new treatment strategies. Ann. NY Acad. Sci. (2004) 1024:124-137.
   PubMed Web of Science ®Google Scholar
• SONG I-H, GOLD R, STRAUB RH, BURMESTER G-R, BUTTGEREIT F: New glucocorticoids on the horizon: repress, don't activate! J. Rheumatol. (2005) 32:1199-1207.
   Web of Science ®Google Scholar
• ASHWELL JD, LU FW, VACCHIO MS: Glucocorticoids in T cell development and function*. Ann. Rev. Immunol. (2000) 18:309-345.
   PubMed Web of Science ®Google Scholar
• BARNES PJ, ADCOCK I: Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol. Sci. (1993) 14:436-441.
   PubMed Web of Science ®Google Scholar
• COHEN JJ, DUKE RC: Glucocorticoid activation of a calcium-dependent endonuclease in thymocyte nuclei leads to cell death. J. Immunol. (1984) 132:38-42.
   PubMed Web of Science ®Google Scholar
• SCHACKE H, DOCKE WD, ASADULLAH K: Mechanisms involved in the side effects of glucocorticoids. Pharmacol. Ther. (2002) 96:23-43.
   PubMed Web of Science ®Google Scholar
• SCHACKE H, SCHOTTELIUS A, DOCKE W-D et al.: Dissociation of transactivation from transrepression by a selective glucocorticoid receptor agonist leads to separation of therapeutic effects from side effects. Proc. Natl. Acad. Sci. USA (2004) 101:227-232.
   PubMed Web of Science ®Google Scholar
• BUTTGEREIT F, STRAUB RH, WEHLING M, BURMESTER G-R: Glucocorticoids in the treatment of rheumatic diseases: an update on the mechanisms of action. Arthritis Rheum. (2004) 50:3408-3417.
   PubMed Web of Science ®Google Scholar
• SONG I-H, BUTTGEREIT F: Non-genomic glucocorticoid effects to provide the basis for new drug developments. Mol. Cell. Endocrinol. (2006) 246:142-146.
   PubMed Web of Science ®Google Scholar
• LOWENBERG M, TUYNMAN J, BILDERBEEK J et al.: Rapid immunosuppressive effects of glucocorticoids mediated through Lck and Fyn. Blood (2005) 106:1703-1710.
   PubMed Web of Science ®Google Scholar
• NAUMANN L, FEIST E, STRAUB RH, BURMESTER G-R, BUTTGEREIT F: Potencies of topical glucocorticoids to mediate genomic and nongenomic effects on human peripheral blood mononuclear cells. Biochem. Pharmacol. (2006) 71:530-539.
   PubMed Web of Science ®Google Scholar
• BUTTGEREIT F, BRAND MD, BURMESTER GR: Equivalent doses and relative drug potencies for non-genomic glucocorticoid effects: a novel glucocorticoid hierarchy. Biochem. Pharmacol. (1999) 58:363-368.
   PubMed Web of Science ®Google Scholar
• SANDEN S, TRIPMACHER R, WELTRICH R et al.: Glucocorticoid dose dependent downregulation of glucocorticoid receptors in patients with rheumatic diseases. J. Rheumatol. (2000) 27:1265-1270.
   PubMed Web of Science ®Google Scholar
• BERKI T, TAVAKOLI A, NAGY KK, NAGY G, NEMETH P: Alterations of glucocorticoid receptor expression during glucocorticoid hormone therapy in renal transplant patients. Transplant. Int. (2002) 15:132-138.
   PubMed Web of Science ®Google Scholar
• GAMETCHU B: Glucocorticoid receptor-like antigen in lymphoma cell membranes: correlation to cell lysis. Science (1987) 236:456-461.
   PubMed Web of Science ®Google Scholar
• BARTHOLOME B, SPIES CM, GABER T et al.: Membrane glucocorticoid receptors (mGCR) are expressed in normal human peripheral blood mononuclear cells and up-regulated after in vitro stimulation and in patients with rheumatoid arthritis. FASEB J. (2004) 18:70-80.
   PubMed Web of Science ®Google Scholar
• WURTHWEIN G, REHDER S, ROHDEWALD P: Lipophilicity and receptor affinity of glucocorticoids. Pharm. Ztg Wiss. (1992) 137:161-167.
   Google Scholar
• WURTHWEIN G, ROHDEWALD P: Activation of beclomethasone dipropionate by hydrolysis to beclomethasone-17-monopropionate. Biopharm. Drug Dispos. (1990) 11:381-394.
   PubMed Web of Science ®Google Scholar
• ANDERSSON P, RYRFELDT A: Biotransformation of the topical glucocorticoids budesonide and beclomethasone 17 a, 21-dipropionate in human liver and lung homogenate. J. Pharmacy Pharmacol. (1984) 36:763-765.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• MAGER DE, MOLEDINA N, JUSKO WJ: Relative immunosuppressive potency of therapeutic corticosteroids measured by whole blood lymphocyte proliferation. J. Pharm. Sci. (2003) 92:1521-1525.
   PubMed Web of Science ®Google Scholar
• HARRIS DM: Properties and therapeutic uses of some corticosteroids with enhanced topical potency. J. Steroid Biochem. (1975) 6:711-716.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• MIURA Y, NARIMATSU H, KAMI M et al.: Oral beclomethasone dipropionate as an initial treatment of gastrointestinal acute graft-versus-host disease after reduced-intensity cord blood transplantation. Bone Marrow Transplant. (2006) 38:577-579.
   PubMed Web of Science ®Google Scholar
• CASTILLA C, PEREZ-SIMON JA, SANCHEZ-GUIJO FM et al.: Oral beclomethasone dipropionate for the treatment of gastrointestinal acute graft-versus-host disease (GVHD). Biol. Blood Marrow Transplant. (2006) 12:936-941.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• RAI RM, HENDRIX TR, MOSKALUK C, LEVINE DS, PASRICHA PJ: Treatment of idiopathic lymphocytic enterocolitis with oral beclomethasone dipropionate. Am. J. Gastroenterol. (1997) 92:147-149.
   PubMed Web of Science ®Google Scholar
• TURSI A, BRANDIMARTE G, GIORGETTI GM, ELISEI W: Beclomethasone dipropionate plus VSL#3 for the treatment of mild to moderate diverticular colitis: an open, pilot study. J. Clin. Gastroenterol. (2005) 39:644-645.
   PubMed Web of Science ®Google Scholar
• TURSI A, GIORGETTI GM, BRANDIMARTE G, ELISEI W, AIELLO F: Beclomethasone dipropionate for the treatment of mild-to-moderate Crohn's disease: an open-label, budesonide-controlled, randomized study. Med. Sci. Monit. (2006) 12:PI29-PI32.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• HOCKENBERY DM, CRUICKSHANK S, RODELL TC et al.: A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prenisone-sparing therapy for gastrointestinal graft-versus-host diesease. Blood (2007) 109:4557-4563.
   PubMed Web of Science ®Google Scholar
• BANSKY G, BUHLER H, STAMM B, HASKI WH, BUCHMANN P, MULLER J: Treatment of distal ulcerative colitis with beclomethasone enemas: high therapeutic efficacy without endocrine side effects: a prospective, randomized, double-blind trial. Dis. Colon Rectum (1987) 30:288-292.
   PubMed Web of Science ®Google Scholar
• SARI I, ALTUNTAS F, KOCYIGIT I et al.: The effect of budesonide mouthwash on oral chronic graft versus host disease. Am. J. Hematol. (2007) 82:349-356.
   PubMed Web of Science ®Google Scholar
• WADA H, MORI A, OKADA M et al.: Treatment of intestinal graft-versus-host disease using betamethasone enemas. Transplantation (2001) 72:1451-1453.
   PubMed Web of Science ®Google Scholar