Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial.
OBJECTIVE
Eosinophilic esophagitis (EoE) is caused by immunologic reactions to ingested/inhaled allergens. The diagnosis is considered if >or=15 eosinophils per high-powered field (eos/hpf) are detected in mucosal biopsies. Placebo-controlled studies have not been conducted to evaluate the safety and efficacy of oral viscous budesonide (OVB).


METHODS
Children with EoE were randomly assigned to groups that were given OVB (n=15) or placebo (n=9). Patients<5 feet and >or=5 feet tall received 1 mg and 2 mg OVB daily, respectively. All patients received lansoprazole. Duration of treatment was 3 months, followed by repeat endoscopy and biopsies. Patients were classified as responders if their peak eosinophil counts were <or=6 eos/hpf, partial responders were 7-19 eos/hpf, and nonresponders were >or=20 eos/hpf. Baseline and post-treatment symptoms and endoscopic and histologic features were scored.


RESULTS
Thirteen (86.7%) children given OVB (P<.0001) and none who received placebo (P=.3) were classified as responders. Mean pre-/post-treatment peak eosinophil counts were 66.7 and 4.8 eos/hpf, respectively, in the group given OVB (P<.0001); they were 83.9 and 65.6 eos/hpf, respectively, in the group given placebo (P=.3). In the group given OVB, there were significant reductions from baseline values in proximal (P=.002), mid (P=.0003), and distal (P=.001) esophageal eosinophilia. After OVB therapy, compared with baseline, the mean symptom (P=.0007), endoscopy (P=.0005), and histology scores improved (P=.0035) significantly.


CONCLUSIONS
OVB is an effective treatment of pan-esophageal disease in children with EoE. OVB improves symptoms and endoscopic and histologic features. Proton pump inhibitor single therapy did not significantly improve esophageal eosinophilia or symptoms of EoE.
Dohil
Ranjan
R
Departments of Pediatrics and Pathology, University of California, San Diego, La Jolla, California; and Rady Children's Hospital San Diego, San Diego, California 92103-8450, USA. rdohil@ucsd.edu
Newbury
Robert
R
Fox
Lyman
L
Bastian
John
J
Aceves
Seema
S
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000284:Administration, Oral; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000737:chemistry; D001706:Biopsy; D019819:Budesonide / Q000008:administration & dosage* / Q000737:chemistry; D002648:Child; D002675:Child, Preschool; D004304:Dosage Forms; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004802:Eosinophilia / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D004941:Esophagitis / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D004945:Esophagoscopy; D004947:Esophagus / Q000737:chemistry / Q000187:drug effects* / Q000473:pathology; D005260:Female; D005355:Fibrosis; D005838:Genotype; D006801:Humans; D007150:Immunohistochemistry; D007223:Infant; D064747:Lansoprazole; D008297:Male; D009092:Mucous Membrane / Q000187:drug effects / Q000473:pathology; D010641:Phenotype; D015990:Placebo Effect; D020641:Polymorphism, Single Nucleotide; D011401:Promoter Regions, Genetic; D054328:Proton Pump Inhibitors / Q000494:pharmacology; D053773:Transforming Growth Factor beta1 / Q000032:analysis / Q000235:genetics; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D054328:Proton Pump Inhibitors; D053773:Transforming Growth Factor beta1; D064747:Lansoprazole; D019819:Budesonide