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Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948
Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948
Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.
Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.
Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.
Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.
Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948