Oral involvement is (very) common in chronic graft-versus-host disease and can cause discomfort and impairment of oral function. Budesonide, a highly potent corticosteroid with low systemic activity, can be used as a topical treatment for oral chronic graft-versus-host disease. We describe the development of a formulation of budesonide and sodium bicarbonate for use as mouthwash in patients with oral chronic graft-versus-host disease.
WolffDSteinerBHildebrandtG. Pharmaceutical and cellular strategies in prophylaxis and treatment of graft-versus-host disease. Curr Pharm Des2009; 15: 1974–1997.
6.
TravnikRBeckersMWolffD. Graft-versus-host disease (GvHD) - an update Part 2: Prognosis and therapy of GvHD (in German). Hautarzt2011; 62: 229–239.
7.
EladSZeeviIFinkeJ. Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide – an open, randomized, multicenter study. Biol Blood Marrow Transplant2012; 18: 134–140.
8.
FilipovichAHWeisdorfDPavleticS. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant2005; 11: 945–956.
9.
Lee SJ and Flowers ME. Recognizing and managing chronic graft-versus-host disease. Hematology Am Soc Hematol Educ Program 2008; 134–141.
10.
WolffDGerbitzAAyukF. Consensus conference on clinical practice in chronic graft-versus-host disease (GVHD): First-line and topical treatment of chronic GVHD. Biol Blood Marrow Transplant2010; 16: 1611–1628.
11.
LeeSJKleinJPBarrettAJ. Severity of chronic graft-versus-host disease: Association with treatment-related mortality and relapse. Blood2002; 100: 406–414.
12.
ParkARLaHOChoBS. Comparison of budesonide and dexamethasone for local treatment of oral chronic graft-versus-host disease. Am J Health-Syst Pharm2013; 70: 1383–1391.
13.
Mawardi HH, Al-Mohaya MA and Treister NS. Oral health in cancer survivors. UpToDate, http://www.uptodate.com (2014, accessed 29 July 2014).
14.
EladSOrRGarfunkelAA. Budesonide: A novel treatment for oral chronic graft versus host disease. Oral Surg Oral Med Oral Pathol Oral Radiol Endod2003; 95: 308–311.
15.
SariIAltuntasFKocyigitI. The effect of budesonide mouthwash on oral chronic graft versus host disease. Am J Hematol2007; 82: 349–356.
RutgeertsPLöfbergRMalchowH. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med1994; 331: 842–845.
18.
El FakihRObiGAScholoffA. Systemic effects of oral budesonide in hematopoietic transplant: Implications of drug interaction with azoles. Bone Marrow Transplant2012; 47: 1370–1371.
19.
DilgerKHalterJBertzH. Pharmacokinetics and pharmacodynamic action of budesonide after buccal administration in healthy subjects and patients with oral chronic graft-versus-host disease. Biol Blood Marrow Transplant2009; 15: 336–343.
20.
UtsmanRAEpsteinJBEladS. Budesonide for local therapy of complex oral mucosal immune-mediated inflammatory diseases: Case reports. Oral Surg Oral Med Oral Pathol Oral Radiol Endod2008; 106: e11–e17.
21.
ZadikYNakdimonIMeyerowitzC. Topical budesonide for severe oral chronic graft-versus-host disease. Am J Health Syst-Pharm2014; 71: 181–182.
22.
Dr Falk Pharma GmbH. Efficacy and safety study of budesonide to treat oral chronic graft vs host disease (cGvHD). ClinicalTrials.gov Identifier NCT00887263, https://clinicaltrials.gov/ct2/show/NCT00887263 (2014, accessed 29 July 2014).
23.
de Paula EduardoFBezinelliLMHamerschlakN. Oral care in Brazilian bone marrow transplant centers. Rev Bras Hematol Hemoter2011; 33: 15–20.
24.
McGuireDBFultonJSParkJ. Systematic review of basic oral care for the management of oral mucositis in cancer patients. Support Care Cancer2013; 21: 3165–3177.