A 12-Week Maintenance Therapy with a New Prepared Viscous Budesonide in Pediatric Eosinophilic Esophagitis

Abstract

Background: A new prepared oral viscous budesonide (PVB) has been effective in inducing clinical and histological remission in pediatric eosinophilic esophagitis (EoE).

Aims: To evaluate the efficacy of a 12-week maintenance therapy on clinical, endoscopic, and histological remission using half of the dose used in the induction therapy.

Methods: We prospectively enrolled pediatric patients with active EoE. After 12 weeks of induction therapy with PVB (< 150 cm: 2 mg/day; ≥ 150 cm: 4 mg/day) patients received a maintenance dose of half of the dose used in the induction therapy (1 mg or 2 mg) for another 12 weeks. A 12-week follow-up was then performed in all patients after the end of therapy. Endoscopy was performed at weeks 0, 12, 24, and 36. Symptoms, endoscopy, and histology scores were also calculated. Serum cortisol was evaluated during the treatment period.

Results: We enrolled 20 children (15 males; median age 10 years; range 4-17). After the 12-week induction therapy 18 patients (90%) were in remission, with a significant decrease in the median peak of eosinophil count/HPF as well as a marked reduction in clinical, endoscopic, and histological scores (p < 0.01). At the end of the maintenance therapy (week 24), 17 patients (85%) were still in remission, while there were only 9 at week 36 (45%). No significant changes in cortisol levels were observed during the study period.

Conclusions: The 12-week maintenance treatment with the half the dose of PVB was effective in sustaining remission at week 24; however, no reduction in the rate of relapse after suspension of treatment occurred.

Keywords: Elimination diet; Eosinophilic esophagitis; Oral viscous budesonide; PPIs; Pediatric endoscopy.

Fig. 1

Flowchart of the study

Fig. 2

Values of peak eosinophil count before and after induction and maintenance phases of the treatment with the new suspension of oral viscous budesonide. *p < 0.01, weeks 12 and 24 compared with the baseline. Week 12 compared with week 24, p = 0.19

Fig. 3

Percentage of responders after 12- and 24-week treatment and at 36-week follow-up

Fig. 4

Median values and IQR of symptom score (a), endoscopy score (b), and histology score (c) during the study period, *p < 0.01