The effect of budesonide mouthwash on oral chronic graft versus host disease

Abstract

Oral chronic graft versus host disease (cGVHD) is common and a major cause of morbidity and loss of quality of life in long term survivors. Cyclosporine with prednisone remains the first line therapy for oral manifestations of cGVHD. However, even with routine administration of systemic agents, many patients with oral manifestations of cGVHD do not have resolution of their disease and may benefit from incorporation of local therapy. Budesonide is a highly potent steroid which has minimal systemic side effects and being used for oral cGVHD. We designed a retrospective study to compare treatment results of patients with oral cGVHD who received topical budesonide in addition to systemic therapy that consists of combined prednisone and cyclosporine (Group A, n = 12), with the treatment results of patients who were administered the same systemic therapy alone (Group B, n = 11) to determine whether budesonide mouthwash had any advantage on response rates. Three mg topical budesonide/10 ml saline was used 3-4 times a day for up to 6 months in group A. Diagnosis, clinical staging, and treatment response scoring for cGVHD were performed according to National Institutes of Health (NIH) consensus criteria. At the baseline examination, there were no statistically significant differences in terms of median oral cGVHD examination scores between two groups. After treatment, there was statistically significant decrease in median oral cGVHD examination scores compared to baseline (P < 0.001 and 0.021), and significant differences were found between two groups (P < 0.032). Overall response rate was 83% and 36% for group A and B, respectively (P = 0.036). However, no statistically significant differences were found between median pain scores of two groups before and after treatment (P = 0.740 and P = 0.091). No major systemic side effects and oral candidiasis were observed in two groups of patients. We concluded that topical budesonide might be added to systemic therapy to obtain better response rates in patients with oral cGHVD. Am. J. Hematol. 82:349-356, 2007. V V C 2006 Wiley-Liss, Inc.

Combined topical dexamethasone/tacrolimus therapy for management of oral chronic GVHD

“…As the NIH instruments were only recently introduced, there have been few publications with which to compare these results. 16 The overall magnitude of responses was greater at FU2 compared with FU1, suggesting that duration of therapy is likely an important factor in clinical efficacy. Concurrent systemic immunomodulatory therapies were in large part stable during the evaluation period, further supporting the efficacy of combined topical therapy.…”

“…11,15 Topical corticosteroids and tacrolimus have been reported as effective monotherapy. [12][13][14]16 As cGVHD is routinely managed systemically with multiple medications with complementary mechanisms of action, it is possible that cases of oral cGVHD that are refractory to monotherapy may benefit from a combined topical approach. It was from this premise that we began treating our refractory patients with combined topical DEX/TAC therapy.…”

Pain syndromes in the setting of haematopoietic stem cell transplantation for haematological malignancies

“…The treatment of chronic GVHD relies on the use of a variety of immunosuppressive and immunomodulatory drugs and interventions that include mycophenolate, monoclonal antibodies, sirolimus, pentostatin and extracorporeal photopheresis, as well as corticosteroids. 68 Moreover, corticosteroids 69 and tacrolimus, 70 when locally applied, can provide some therapeutic benefit to patients with GVHD-related oral ulcers. To prevent the occurrence of gastrointestinal mucositis, a panel of experts has recently recommended the administration of sulphalazine to patients undergoing radiotherapy and of octreotide to reduce the frequency and the volume of diarrhoea.…”

How we treat oral chronic graft-versus-host disease

“…Only minimal evidence exists to guide the choice in topical corticosteroid therapy for management of oral mucosal cGVHD. [36][37][38][39][40][41] Based on the National Institutes of Health Consensus Conference Ancillary Guidelines and clinical experience, for the majority of patients, we prescribe oral dexamethasone solution (0.5 mg/5 mL) as initial therapy, with the explicit instructions to swish, gargle (if soft palate involved), and spit the solution. 33 Reports evaluating topical budesonide solution (3 mg/10 mL) have demonstrated good efficacy; however, results are difficult to compare across studies.…”