pulmicort and Graft-vs-Host-Disease

Topics: Administration, Topical; Adrenal Cortex Hormones; Budesonide; Clobetasol; Dexamethasone; Graft vs Host Disease; Humans; Randomized Controlled Trials as Topic

The oral mucosa is commonly involved in chronic graft-versus-host disease (cGVHD). Oral mucosal cGVHD markedly affect individual's daily function and wellbeing. In some cases, it might become a life threating complication. Areas covered: This article describes the rationale for treatment, method of topical application in the oral cavity, evidence supporting the topical administration of dexamethasone and budesonide for oral cGVHD, and their adverse effects. Expert opinion: Evidence supports the use of topical dexamethasone and budesonide for treatment of oral cGVHD. Topical corticosteroid choice for oral cGVHD, takes into consideration the potency, bioavailability, preferred concentration, and possible adverse effects. Budesonide's pharmacological characteristics mark it as a preferable topical agent for oral cGVHD.

Topics: Administration, Topical; Budesonide; Chronic Disease; Dexamethasone; Female; Glucocorticoids; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Male; Mouth Mucosa

For over a decade, nonabsorbable corticosteroids have been employed in the treatment of gastrointestinal graft-versus-host-disease (GVHD) in hematopoietic stem cell transplant (HSCT), as monotherapy or in combination with systemic corticosteroids. The majority of the evidence showing a favorable outcome consisted of case series, small phase II trials and a large randomized phase III trial. The 2 most commonly studied molecules were oral budesonide and beclomethasone diproprionate. Although these reports hint at some benefit with the local treatment strategy, their methodologic inconsistencies preclude meaningful adoption to everyday clinical practice. This review evaluates the current evidence of nonabsorbable corticosteroids in HSCT and sets forth recommendations for future trials with these agents.

Topics: Beclomethasone; Budesonide; Clinical Trials as Topic; Gastrointestinal Diseases; Glucocorticoids; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Treatment Outcome

Gastrointestinal graft-versus-host disease (GvHD) is a potentially life-threatening complication after allogeneic stem cell transplantation (SCT). Since therapeutic options are still limited, a prophylactic approach seems to be warranted.. In this randomised, double-blind-phase III trial, we evaluated the efficacy of budesonide in the prophylaxis of acute intestinal GvHD after SCT. The trial was registered at https://clinicaltrials.gov, number NCT00180089.. The crude incidence of histological or clinical stage 3-4 acute intestinal GvHD until day 100 observed in 91 (n =48 budesonide, n =43 placebo) evaluable patients was 12.5% (95% CI 3-22%) under treatment with budesonide and 14% (95% CI 4-25%) under placebo (p = 0.888). Histologic and clinical stage 3-4 intestinal GvHD after 12 months occurred in 17% (95% CI 6-28%) of patients in the budesonide group and 19% (CI 7-32%) in the placebo group (p = 0.853). Although budesonide was tolerated well, we observed a trend towards a higher rate of infectious complications in the study group (47.9% versus 30.2%, p = 0.085). The cumulative incidences at 12 months of intestinal GvHD stage >2 with death as a competing event (budesonide 20.8% vs. placebo 32.6%, p = 0.250) and the cumulative incidence of relapse (budesonide 20.8% vs. placebo 16.3%, p = 0.547) and non-relapse mortality (budesonide 28% (95% CI 15-41%) vs. placebo 30% (95% CI 15-44%), showed no significant difference within the two groups (p = 0.911). The trial closed after 94 patients were enrolled because of slow accrual. Within the limits of the final sample size, we were unable to show any benefit for the addition of budesonide to standard GvHD prophylaxis.. Budesonide did not decrease the occurrence of intestinal GvHD in this trial. These results imply most likely that prophylactic administration of budenoside with pH-modified release in the terminal ileum is not effective.

Topics: Administration, Oral; Budesonide; Double-Blind Method; Female; Gastrointestinal Diseases; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged

The results of a prospective study of topical budesonide versus topical dexamethasone therapy for oral manifestations of chronic graft-versus-host disease (cGVHD) are presented.. In a prospective single-center investigation, a cohort of patients who developed oral symptoms of cGVHD after allogeneic stem cell transplantation were assigned to topical treatment with 0.03% budesonide rinse (group A, n = 26) or 0.01% dexamethasone rinse (group B, n = 24). Diagnosis of oral cGVHD symptoms, clinical staging, and treatment response scoring were performed at baseline and one month later according to current National Institutes of Health consensus criteria.. At one-month follow-up, there was a significant decrease in the median oral cGVHD examination score in both groups (p < 0.001); the decrease in the median examination score was greater with budesonide versus dexamethasone therapy (2.5 points versus 1.0 point, p = 0.045). The rates of overall treatment response, including complete and partial responses, were 53.8% and 29.2% in groups A and B, respectively (p = 0.093). In addition, there was a significant decrease from baseline in the median self-rated oral pain severity score in group A (p < 0.001).. Patients who received topical budesonide or dexamethasone rinse to treat oral manifestations of cGVHD had decreased cGVHD severity and pain scores after 30 days compared with baseline scores, though no statistical differences were seen between groups.

Topics: Budesonide; Chronic Disease; Dexamethasone; Female; Graft vs Host Disease; Humans; Immunosuppressive Agents; Male; Medication Adherence; Middle Aged; Mouth Diseases; Mouthwashes

Chronic graft-versus-host disease (cGVHD) frequently involves oral tissues. Although the mucosal changes may be painful and impair oral function, there is currently no topical therapy available for oral cGVHD that has been proven to work in an evidence-based manner. The aims of this study were to (1) assess the response of patients with oral cGVHD to various doses of a new topical budesonide formulation; (2) evaluate the efficacy and safety of the new topical budesonide formulation in these patients. An open, randomized, multicenter phase II pilot study with 4 treatment arms differing in application frequency and duration was performed. Response to treatment was scored by the clinician and patient using several scales. Oral cGVHD improved in all patients, with a median reduction of 70%. Pain reduction was similar in all study arms. The rate of objective improvement (defined as ≥50%) was not significantly different among the 4 study arms. The safety profile was satisfactory. Topical budesonide mouthwash (3 mg/10 mL) improved oral cGVHD in all patients when applied for 5 or 10 minutes, 2 or 3 times daily. The response was similar in all treatment arms. Safety analysis supported a dosing schedule of 3 mg of budesonide 3 times a day for 10 minutes.

Topics: Administration, Topical; Adult; Budesonide; Chronic Disease; Drug Administration Schedule; Female; Graft vs Host Disease; Humans; Male; Middle Aged; Mouthwashes; Pilot Projects; Tablets

Topics: Administration, Oral; Aged; Anti-Inflammatory Agents; Azoles; Budesonide; Cushing Syndrome; Drug Interactions; Female; Gastrointestinal Diseases; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Iatrogenic Disease; Leukemia, Myeloid, Acute; Male; Middle Aged; Transplantation, Homologous

Buccal administration of budesonide (mouthwash) may be effective as a topical add-on therapy in patients with oral chronic graft-versus-host disease (cGVHD). Safety of approved oral budesonide is based on high intestinal and hepatic extraction by cytochrome P450 3A (CYP3A) enzymes. The purpose of this study was to evaluate the presystemic extraction and pharmacodynamic action of buccal budesonide. Oral budesonide (3 mg) was taken as reference to which various single and multiple dose regimens of buccal budesonide were compared. Budesonide and the 2 main CYP3A-dependent metabolites (6beta-hydroxybudesonide, 16alpha-hydroxyprednisolone) were analyzed in blood and urine along with the drug's effect on endogenous cortisol in 12 healthy subjects and 7 patients with oral cGVHD. We assessed CYP3A-dependent metabolites in both healthy subjects and patients after buccal budesonide. Whereas systemic exposure to budesonide was markedly lower in healthy subjects after the mouthwash compared to oral dosing (mean relative bioavailability 18%-36%), the systemic concentrations thereafter in patients were as high as those after the identical dose of oral budesonide. Reduced buccal CYP3A activity (lower inactivation of budesonide) in patients contributed to this remarkable difference. Endogenous cortisol was suppressed in some patients during 1 week of continuous treatment with buccal budesonide (3 x 3 mg per day). We are the first to report the biotransformation of budesonide via CYP3A enzymes after buccal drug administration. Only 2% of a buccal dose of budesonide achieves systemic circulation in healthy individuals; that fraction is 10% in patients with oral cGVHD, probably because of alterations in drug uptake and metabolization.

Topics: Administration, Buccal; Administration, Oral; Adult; Biological Availability; Biotransformation; Budesonide; Case-Control Studies; Chronic Disease; Cytochrome P-450 CYP3A; Drug Administration Schedule; Female; Graft vs Host Disease; Humans; Hydrocortisone; Male; Mouthwashes; Prednisolone

This clinical trial aims to evaluate the efficacy of budesonide, a newly registered steroid with high potency and low bioavailability, for the treatment of chronic oral graft versus host disease (GVHD).. Twelve patients with chronic resistant oral GVHD were treated with 3 mg budesonide/5 ml saline 2 to 3 times a day for up to 3 months. Oral manifestations were monitored, and mucosal response scored.. All patients responded positively to the mouthwash, and 7 of the 12 patients were scored as having "good" or "complete" recovery by both examiner and subject. An early response noted within the first 2 to 3 weeks of treatment was complemented by a probable cumulative effect seen during the first months of treatment.. Budesonide is suggested as an alternative treatment for chronic oral GVHD.

Topics: Adult; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Middle Aged; Mouth Diseases; Mouth Mucosa; Mouthwashes

Therapy of acute intestinal GVHD is still one of the main challenges after allogeneic transplantation. Increasing systemic immunosuppression (IS) is the first choice and includes corticosteroids and lymphocyte antibodies, often associated with severe side-effects. In inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, topical steroid therapy is used very successfully. Because of the similarity between these and acute intestinal GVHD we conducted a trial with oral budesonide (Budenofalk), a new topically active glucocorticoid, to treat patients with acute GVHD > or = grade II. After a diagnosis of aGVHD > or = grade II, 22 patients received increased IS, mainly systemic corticosteroids, and additionally budesonide 9 mg/day divided into three doses. Improvement in aGVHD, infectious side-effects, reduction of systemic IS and outcome were documented. Results were compared with the results of 19 control patients, who were treated only by increasing IS dose. In 17/22 patients (70%), treated with budesonide, the acute intestinal GVHD resolved and no relapse occurred after decreasing the systemic IS, while continuing budesonide. In only 8/19 patients in the control group did the acute intestinal GVHD resolve and 2/8 patients had a relapse of intestinal GVHD after decreasing IS, with an overall response of 33%. No severe intestinal infections occurred. We conclude that budesonide may be effective in acute intestinal GVHD as a topical corticosteroid and prospective, randomized studies should demonstrate its efficacy in allowing reduction of systemic immunosuppressive therapy, and its side-effects.

Topics: Acute Disease; Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Behavior Therapy; Bone Marrow Transplantation; Budesonide; Child; Endoscopy; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppression Therapy; Intestinal Diseases; Male; Middle Aged; Sibling Relations; Survival Rate; Time Factors; Transplantation, Homologous; Treatment Outcome

The treatment of chronic pouchitis remains a challenge due to the paucity of high-quality studies. We aimed to provide guidance for clinicians on the appropriateness of medical and surgical treatments in chronic pouchitis.. Appropriateness of medical and surgical treatments in patients with chronic pouchitis was considered in 16 scenarios incorporating presence/absence of four variables: pouchitis symptoms, response to antibiotics, significant prepouch ileitis, and Crohn's disease (CD)-like complications (i.e., stricture or fistula). Appropriateness of permanent ileostomy in patients refractory to medical treatments was considered in eight additional scenarios. Using the RAND/UCLA appropriateness method, international IBD expert panelists rated appropriateness of treatments in each scenario on a 1-9 scale.. Chronic antibiotic therapy was rated appropriate only in asymptomatic antibiotic-dependent patients with no CD-like complications and inappropriate in all other scenarios. Ileal-release budesonide was rated appropriate in 6/16 scenarios including patients with significant prepouch ileitis but no CD-like complications. Probiotics were considered either inappropriate (14/16) or uncertain (2/16). Biologic therapy was considered appropriate in most scenarios (14/16) and uncertain in situations where significant prepouch ileitis or CD-like complications were absent (2/16). In patients who are refractory to all medications, permanent ileostomy was considered appropriate in all scenarios (7/8) except in asymptomatic patients with no CD-like complications.. In the presence of significant prepouch ileitis or CD-like complications, chronic antibiotics and probiotics are inappropriate. Biologics are appropriate in all patients except in asymptomatic patients with no evidence of complications. Permanent ileostomy is appropriate in most medically refractory patients.

Topics: Anti-Bacterial Agents; Biological Products; Budesonide; Crohn Disease; Graft vs Host Disease; Humans; Ileitis; Pouchitis

The gastrointestinal (GI) tract is commonly affected by acute and chronic graft-versus-host disease (GVHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). For patients developing GI GVHD, nonabsorbable corticosteroids such as budesonide may be used alone to reduce the risk of systemic corticosteroid toxicities or combined with systemic steroids to enhance clinical responses and to allow more rapid tapering of systemic corticosteroid doses. This prospective crossover study was conducted to evaluate what effect two commonly used antifungal agents, fluconazole, and voriconazole, would have on the trough (Cmin) and peak (Cmax) levels of budesonide in adult patients who had undergone allo-HSCT who subsequently developed clinical GI GVHD. Fifteen subjects were enrolled and nine completed the study and were evaluable. When coadministered with budesonide, voriconazole significantly increased the geometric mean of budesonide Cmin and Cmax levels by 8.52- and 6.63-fold, respectively. The cohort to evaluate the interaction with fluconazole did not meet accrual goals to reach definitive conclusions. In conclusion, this prospective study demonstrated that when patients with GI GVHD are treated with budesonide concurrently with voriconazole, the systemic concentrations of budesonide increase substantially which could increase the risk of steroid-associated toxicities.

Topics: Adult; Budesonide; Cross-Over Studies; Fluconazole; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Prospective Studies; Voriconazole

Systemic glucocorticoids remain the standard treatment for gastrointestinal (GI) acute graft-versus-host disease (aGVHD) despite their toxicity and incomplete efficacy. Controlled trials have tested poorly absorbable steroids as adjuncts with systemic glucocorticoids, but only small case series have reported treatment with poorly absorbed beclomethasone dipropionate (BDP) and budesonide (BUD) alone. Our team has adopted the practice of administering BDP or BDP+BUD without systemic glucocorticoids as first-line therapy for isolated upper GI (UGI) aGVHD. We report results in 76 patients treated with BDP alone and in 81 patients treated with BDP+BUD, with allocation by physician choice. Almost all patients received peripheral blood stem cells (92%) from a fully HLA-matched related or unrelated donor (80%) after myeloablative conditioning (76%) for acute leukemia (49%), myelodysplastic syndrome (17%), non-Hodgkin lymphoma (14%), or another hematopoietic disorders (20%). After 28 days of treatment with BDP, 46% of the patients had a complete response (CR) and 10% had a partial response (PR); after 200 days, 61 (80%) patients were alive, 34% maintained a CR, and 3% maintained a PR, whereas 53% required additional immunosuppression (IS). After 28 days of treatment with BDP+BUD, 67% had a CR and 10% a PR; after 200 days, 74 (91%) patients were alive, 46% maintained a CR, and 2% maintained a PR, whereas 43% required additional IS. Among the entire cohort of 157 patients, 66 (42%) were treated successfully without systemic glucocorticoids. This study reports the efficacy of poorly absorbable steroids alone for patients with isolated UGI aGVHD. Prospective trials should test for the potential advantages of BDP and BUD use over systemic glucocorticoids.

Topics: Adult; Aged; Anti-Inflammatory Agents; Beclomethasone; Budesonide; Female; Graft vs Host Disease; Humans; Male; Middle Aged; Prospective Studies

Graft versus Host Disease (GVHD) after orthotopic liver transplant (OLT), although rare, carries >80% mortality. Early diagnosis, prompt treatment, and aggressive supportive care are imperative to potentially reverse this otherwise fatal ailment. We describe a case of severe diarrhoea post living donor OLT who was diagnosed with acute GVHD. Addition of oral budesonide therapy to systemic corticosteroid therapy controlled the symptoms of diarrhoea.

Topics: Acute Disease; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Biopsy; Budesonide; Diarrhea; Drug Therapy, Combination; End Stage Liver Disease; Female; Graft vs Host Disease; Humans; Liver; Liver Transplantation; Middle Aged; Postoperative Complications; Recovery of Function; Transaminases

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.

Topics: Administration, Topical; Budesonide; Chemistry, Pharmaceutical; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Mouthwashes

To evaluate the safety and effectiveness of a novel therapeutic regimen for bronchiolitis obliterans sydrome (BOS) affter hematopoietic stem cell transplantation (HSCT).. Seven patients who had received HSCT and had been diagnosed as BOS were enrolled in this study. They received weekly intravenous injection of umbilical cord-derived mesenchymal stem cells (MSC) at a dose of 1 × 10(6)/kg for 4 weeks. Budesonide was given orally at a daily dose of 0.25 g, and salmeterol was inhaled at a dose of 4.5 µg for 3 times per day. Methylprednisolone was given at a dose of 1 mg/(kg·d) for 2 weeks when respiratory failure occured. The dose of methylprednisolone was tapered to 0.25 mg/(kg·d) after 4 weeks and was adjusted according to the occurrence and severity of chronic graft-versus-host disease (cGVHD).. The therapy was generally safe and no severe acute toxicity was observed. One patient died of heart failure during the treatment, the other 6 patients were alive and the pulmonary function parameters including FEV1, FEV1/FVC, PaO2 and AaDO2 were significantly improved after 6 months as compared with the baseline parameters (P < 0.05).. MSC combined with budesonide, almeterol and azithromycin has been confirmed to be generally safe and can reduce the dose of glucocorticoid in treatment of BOS after HSCT.

Topics: Azithromycin; Bronchiolitis Obliterans; Budesonide; Combined Modality Therapy; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Mesenchymal Stem Cell Transplantation; Methylprednisolone; Salmeterol Xinafoate

Oral chronic graft versus host disease (cGVHD) is often refractory to systemic therapies. Additional topical treatment is commonly required. The potency of the agent, the vehicle and formulation in which it is delivered are all critical factors in determining the effectiveness of topical therapies. High potency of budesonide, combined with its very low bioavailability when absorbed through mucosal surfaces, increased the potential role in topical application for oral cGVHD. Viscous formulation increases mucosal contact time resulting in a greater decrease in mucosal inflammation. This short communication suggests that oral viscous budesonide should be considered as a potential new therapy in the management of oral cGVHD.

Topics: Administration, Topical; Budesonide; Child; Chronic Disease; Female; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Mouth Diseases; Mouth Mucosa; Oral Ulcer

Topics: Budesonide; Dexamethasone; Female; Graft vs Host Disease; Humans; Male; Mouth Diseases

Manifestations of and risk factors for graft-versus-host disease (GVHD) after double-unit cord blood transplantation (DCBT) are not firmly established. We evaluated 115 DCBT recipients (median age, 37 years) who underwent transplantation for hematologic malignancies with myeloablative or nonmyeloablative conditioning and calcineurin inhibitor/mycophenolate mofetil immunosuppression. Incidence of day 180 grades II to IV and III to IV acute GVHD (aGVHD) were 53% (95% confidence interval, 44 to 62) and 23% (95% confidence interval, 15 to 31), respectively, with a median onset of 40 days (range, 14 to 169). Eighty percent of patients with grades II to IV aGVHD had gut involvement, and 79% and 85% had day 28 treatment responses to systemic corticosteroids or budesonide, respectively. Of 89 engrafted patients cancer-free at day 100, 54% subsequently had active GVHD, with 79% of those affected having persistent or recurrent aGVHD or overlap syndrome. Late GVHD in the form of classic chronic GVHD was uncommon. Notably, grades III to IV aGVHD incidence was lower if the engrafting unit human leukocyte antigen (HLA)-A, -B, -DRB1 allele match was >4/6 to the recipient (hazard ratio, 0.385; P = .031), whereas engrafting unit infused nucleated cell dose and unit-to-unit HLA match were not significant. GVHD after DCBT was common in our study, predominantly affected the gut, and had a high therapy response, and late GVHD frequently had acute features. Our findings support the consideration of HLA- A,-B,-DRB1 allele donor-recipient (but not unit-unit) HLA match in unit selection, a practice change in the field. Moreover, new prophylaxis strategies that target the gastrointestinal tract are needed.

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Budesonide; Calcineurin; Calcineurin Inhibitors; Child; Child, Preschool; Cord Blood Stem Cell Transplantation; Enzyme Inhibitors; Female; Gastrointestinal Tract; Graft vs Host Disease; Hematologic Neoplasms; Histocompatibility Testing; HLA Antigens; Humans; Infant; Male; Middle Aged; Mycophenolic Acid; Myeloablative Agonists; Severity of Illness Index; Survival Analysis; Transplantation Conditioning; Transplantation, Homologous; Treatment Outcome

Topics: Anti-Inflammatory Agents; Beclomethasone; Biopsy; Budesonide; Calcinosis; Colonic Diseases; Endoscopy, Digestive System; Female; Gastric Mucosa; Graft vs Host Disease; Humans; Middle Aged; Stem Cell Transplantation

Local immunosuppressive therapies without systemic effects represent a therapeutic advantage in management of immune/inflammatory oral mucosal conditions. Topical budesonide rinses were prescribed to patients with mucosal disease that was resistant to other intervention without side effects. A case of paraneoplastic pemphigus and a patient with oral graft-versus-host disease that had not responded to standard approaches to management were successfully managed with budesonide rinse application. The cases presented represent mucosal conditions that were successfully managed with topical application of budesonide with reduced risk of systemic effects.

Topics: Anti-Inflammatory Agents; Budesonide; Graft vs Host Disease; Humans; Immunosuppressive Agents; Leukemia, Lymphoid; Lymphoma, Follicular; Male; Middle Aged; Mouth Diseases; Mouth Mucosa; Mouthwashes; Mucocele; Neutrophil Infiltration; Paraneoplastic Syndromes; Pemphigus

Budesonide (BUD) is a steroid with a low bioavailability, which has been used for the treatment of oral manifestations of chronic GVHD (cGVHD). We retrospectively evaluated the efficacy of BUD in the treatment of gastrointestinal cGVHD. Thirteen patients (median age 47 years) receiving BUD for the treatment of cGVHD after allogeneic hematopoietic SCT for hematological malignancies were evaluated for response. Five patients had isolated gastrointestinal cGVHD and 8 patients had mild multiorgan involvement including gastrointestinal manifestations. Six patients received CYA at the time of onset of cGVHD, which was continued during treatment with BUD. Treatment consisted of BUD, with an initial daily dose of 3 x 3 mg orally. Complete resolution of cGVHD was achieved in seven patients, and one patient achieved partial remission of cGVHD. One patient achieved complete resolution of gastrointestinal cGVHD, while systemic manifestations of cGVHD remained stable. Four patients progressed on BUD. Owing to the predominantly local effect, relapse of symptoms of cGVHD after withdrawal of immunosuppression (n=3) as well as progression of GVHD at other sites (n=3) has been observed. BUD represents a treatment option in mild-to-moderate cGVHD, which is well tolerated and associated with a high response rate in gastrointestinal cGVHD.

Topics: Administration, Oral; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Chronic Disease; Cyclosporine; Female; Gastrointestinal Diseases; Graft vs Host Disease; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Remission Induction; Transplantation, Homologous

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.

Topics: Adult; Budesonide; Candidiasis, Oral; Chronic Disease; Cohort Studies; Cyclosporine; Drug Evaluation; Drug Therapy, Combination; Female; Graft vs Host Disease; Hematologic Neoplasms; Humans; Immunosuppressive Agents; Male; Middle Aged; Mouthwashes; Pain Measurement; Peripheral Blood Stem Cell Transplantation; Prednisone; Retrospective Studies; Sodium Chloride; Stomatitis; Transplantation Conditioning; Treatment Outcome

Topics: Acute Disease; Anti-Inflammatory Agents; Budesonide; Child, Preschool; Graft vs Host Disease; Humans; Intestinal Diseases; Male; Treatment Outcome