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Treatment of allergic eosinophilic esophagitis with oral prednisone and swallowed fluticasone a randomized, prospective study in children



Treatment of allergic eosinophilic esophagitis with oral prednisone and swallowed fluticasone a randomized, prospective study in children



Digestive Disease Week Abstracts & Itinerary Planner: Abstract 149,.



INTRODUCTION: AEE is being increasingly recognized in children and adults. The two main therapies for AEE are elemental diet and corticosteroids (i.e. oral P and swallowed F). AIM: To compare response of children with AEE to P and F. METHODS: Children with histologically proven AEE are randomized, at Week 0, to P (1 mg/kg/dose bid) or F (110mcg for age < 11 yrs and 220mcg for age >11 yrs; 2 puffs qid) for 4 weeks at which time (Week 4) a repeat EGD with esophageal biopsies is performed. The drugs are weaned off over the next 8 weeks (Week 12), and the patients are clinically monitored, off drugs, at Week 18 and Week 24 (study end). We compared the histological findings at Week 0 with Week 4 (graded normal, mild, moderate and severe). We also studied the continued absence/relapse of symptoms. RESULTS: 50 children have been enrolled so far - 26 in the P arm (21 males; mean age 7.32 yrs; range 1.33-15.25 yrs) and 24 in the F arm (14 males; mean age 7.46 yrs; range 1.25-16.08 yrs). Of these, 20 and 22 children, respectively, completed Week 4 and will be analyzed further. HISTOLOGY(comparing Week 0 with Week 4): Of the 20 P patients, histological findings went from severe to normal in 18, from severe to mild in 1, and were unchanged in 1 child. Of the 22 F patients, histological findings went from severe to normal in 11, from severe to mild in 4, from moderate to normal/mild in 1 each, from severe to moderate in 3, and were unchanged in 2 children. Overall 19/20 P patients and 20/22 F patients had histological improvement but the degree of improvement was better with P (p <.05). SYMPTOMS: At Week 4, all P and 19/22 F patients were essentially free of the presenting symptom(s). At Week 24, 7 of the 20 P patients stayed asymptomatic. The others had exited due to symptom recurrence (n7), side effects (n1) or voluntarily (n4); 1 child is pending Week 24 visit. At Week 24, 8 of the 22 F patients were essentially asymptomatic. The others had exited earlier due to symptom recurrence (n7), lack of histological improvement (n1) or voluntarily (n6). There were no statistically significant differences between the P and F treated patients in terms of continued remission or symptom relapse. CONCLUSIONS: In this prospective study, the healing rates and symptom resolution with F were similar to those with P. P did result in better histological resolution, but this did not translate into better long- term disease remission. Long-term maintenance therapy of AEE should be considered due to considerable risk of relapse.

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Accession: 035980906

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