title: Improvement in oral chronic graft-versus-host disease with the administration of effervescent tablets of topical budesonide-an open, randomized, multicenter study.
abstract: 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.
authors.affiliation: Department of Oral Medicine, Hebrew University-Hadassah School of Dental Medicine, Jerusalem, Israel. sharon.elad@ekmd.huji.ac.il
authors.forename: Sharon
authors.initials: S
authors.lastname: Elad
authors.forename: Itai
authors.initials: I
authors.lastname: Zeevi
authors.forename: Jürgen
authors.initials: J
authors.lastname: Finke
authors.forename: Michael
authors.initials: M
authors.lastname: Koldehoff
authors.forename: Rainer
authors.initials: R
authors.lastname: Schwerdtfeger
authors.forename: Daniel
authors.initials: D
authors.lastname: Wolff
authors.forename: Ralf
authors.initials: R
authors.lastname: Mohrbacher
authors.forename: Michael
authors.initials: M
authors.lastname: Levitt
authors.forename: Roland
authors.initials: R
authors.lastname: Greinwald
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Shapira
mesh_terms: D000287:Administration, Topical; D000328:Adult; D019819:Budesonide / Q000008:administration & dosage*; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000008:administration & dosage; D010865:Pilot Projects; D013607:Tablets / Q000008:administration & dosage
chemical_list: D009067:Mouthwashes; D013607:Tablets; D019819:Budesonide