SNFGE SNFGE
 
Thématique :
- Endoscopie/Imagerie
Originalité :
Très original
Solidité :
Très solide
Doit faire évoluer notre pratique :
Pas encore
 
 
Nom du veilleur :
Docteur Jean-Michel ROUILLON
Coup de coeur :
 
 
Gastroenterology
  2017/03  
 
  2017 Mar;152(4):776-786.e5.  
  doi: 10.1053/j.gastro.2016.11.021.  
 
  Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis.  
 
  Dellon ES, Katzka DA, Collins MH, Hamdani M, Gupta SK, Hirano I; MP-101-06 Investigators.  
  https://www.ncbi.nlm.nih.gov/pubmed/27889574  
 
 

Abstract

BACKGROUND & AIMS:

Pharmacologic treatment of eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esophageal delivery. We performed a randomized, controlled phase 2 trial to assess the ability of budesonide oral suspension (BOS), a novel muco-adherent topical steroid formulation, to reduce symptoms and esophageal eosinophilia in adolescents and adults with EoE.

METHODS:

In this multicenter, randomized, double-blind, placebo-controlled, parallel-group trial, 93 EoE patients between the ages of 11 and 40 years with dysphagia and active esophageal eosinophilia were randomized to receive either BOS 2 mg or placebo twice daily for 12 weeks. Co-primary outcomes were change in Dysphagia Symptom Questionnaire (DSQ) score from baseline, and proportion of patients with a histologic response (≤6 eosinophils/high-power field) after treatment. Endoscopic severity scores and safety parameters were assessed.

RESULTS:

At baseline, mean DSQ scores were 29.3 and 29.0, and mean peak eosinophil counts were 156 and 130 per hpf in the BOS and placebo groups, respectively. After treatment, DSQ scores were 15.0 and 21.5, and mean peak eosinophil counts were 39 and 113 per high-power field, respectively (P < .05 for all). For BOS vs placebo, change in DSQ score was -14.3 vs -7.5 (P = .0096), histologic response rates were 39% vs 3% (P < .0001), and change in endoscopic severity score was -3.8 vs 0.4 (P < .0001). Adverse events were similar between groups.

CONCLUSIONS:

Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments. ClinicalTrials.gov ID NCT01642212.

 

 
Question posée
 
Quelle est l'efficacité d'une nouvelle forme de suspension orale de Budésonide dans les oesophagites à éosinophiles ?
 
Question posée
 
Cette phase 2, randomisée en double aveugle versus placebo montre une efficacité très significative en terme d'amélioration des scores de dysphagie ( p: 0.009) et d'infiltration éosinophilique ( p<0.0001).
 
Commentaires

Cette étude Américaine très solide montre clairement une efficacité clinique et histologique de cette nouvelle galénique de Budésonide et on attendra donc sa disponibilité en Europe. 

 
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