Details

Autor(en) / Beteiligte

• ELAD, SHARON
• SCHMELZ, RENATE
• WAGNER, EVA
• BOSI, ALBERTO
• BABATZ, JANA
• MEYER, RALF
• DONNINI, IRENE
• HEIM, DOMINIK
• HALTER, JÖRG
• WOLFF, DANIEL WOLF
• KOLDEHOFF, MICHAEL
• SCHÄFER-ECKARDT, KERSTIN
• GREINIX, HILDEGARD
• IRRERA, GUISEPPE
• SUCAK, GÜLSAN
• KASPARU, HEDWIG
• KOBBE, GUIDO
• DUENZINGER, ULRICH
• JEBAVY, LADISLAV
• MEILLER, TIMOTHY
• EPSTEIN, JOEL
• ZADIK, YEHUDA
• MOHRBACHER, RALF
• GREINWALD, ROLAND
• SHAPIRA, MICHAEL

Titel

Double-Blind, Randomized, Placebo-Controlled Multi-Center Phase III Study Followed by Open-Label Phase on the Efficacy and Tolerability of Budesonide in Patients with Resistant Oral Chronic GVHD: Part 2 – Pain, Subjective Measures and Safety Analysis

Ist Teil von

• Oral surgery, oral medicine, oral pathology and oral radiology, 2023-02, Vol.135 (2), p.e43-e44

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2023

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Objectives: Chronic GVHD (cGVHD) affects multiple organs, including the oral mucosa. It is associated with pain, may negatively affect oral function and impair the quality of life. The objective of this study is to compare the efficacy of budesonide versus placebo in relieving pain and improving subjective outcome measures in patients with resistant oral cGVHD. Additionally, to compare the safety profile of budesonide versus placebo. Methods: This study was a double-blind, randomized, placebo-controlled multi-center adaptive phase III clinical trial (DBP) followed by an open-label phase (OLP). In the DBP patients were treated with budesonide 3 mg effervescent tablet (9 mg/day) or placebo for 3 months. In the OLP all patients were treated with budesonide 9 mg/day for an additional 9 months. The study will be reported in 2 sections. In this part of the study, the primary efficacy outcomes were pain relief, safety profile and frequency of adverse events. Multiple indices were used to assess pain: Mouth pain assessment, patient's ability to eat, assessment of efficacy by investigator/patient, assessment of cGVHD. Results: Exploratory analyses of secondary outcomes showed results in favor of budesonide during DBP. Descriptive analysis showed 50% pain reduction in the budesonide group versus 37% in the placebo group. Patients assessed the treatment as effective (p=0.037). Likewise, during the OLP pain relief determined using WHO toxicity criteria and Mouth Pain Assessment each were statistically significant(p<0.000). The safety profile was good. Conclusions: The study suggests that budesonide is safe and effective for the topical treatment of resistant oral cGVHD. The significant pain relief, and improvements noted by the examiners and patients are important clinical outcomes.