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Swallowed Flonase Effective for Long-term Maintenance in Pediatric EoE
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Long-term use of swallowed Flonase safely maintained endoscopic and clinical improvements and reductions in esophageal eosinophils among children with eosinophilic esophagitis, according to the results of an open-label, prospective, single-center study.
“Topical corticosteroids in the form of fluticasone propionate [Flonase, GlaxoSmithKline] to swallow or oral viscous budesonide have been shown to be effective in children ... but their efficacy or safety for chronic use has not yet been established,” researchers from the Icahn School of Medicine at Mount Sinai wrote. “The longest treatment duration reported is 6 months in children, with some efficacy of the drug still demonstrated and with minimal side effects.”
To determine the long-term safety and efficacy of swallowed fluticasone propionate in children with EoE, the researchers evaluated 54 patients with confirmed active EoE who received two puffs of fluticasone propionate twice a day at a dose based on age-specific asthma treatment.
Most patients were boys and the median age of the total cohort was 6.5 years. Eighty-five percent had other atopic conditions and 74% had a history of immunoglobulin E-mediated food allergy. Patients who achieved remission in the short-term continued clinical follow-up every 4 months and endoscopic and histological follow-up annually for a mean duration of 20.4 months (longest follow-up, 68 months).
Esophageal eosinophil counts significantly decreased from baseline within 4 months, at 4 to 12 months, 13 to 24 months and beyond 24 months follow-up (all P < .01). Histological features also significantly decreased from baseline at all follow-up time points (all P < .01), as did the percentage of patients with lamina propria fibrosis (all P < .01), endoscopic features (all P <.01 except beyond 24 months [P < .05]), and symptoms (all P < .05 except beyond 24 months [P = .05]).
Furthermore, a mixed linear regression model accounting for correlation of repeated observations in the same patient in a per-patient analysis showed sustained reductions in peak esophageal eosinophil counts.
In terms of safety, asymptomatic esophageal candidiasis occurred in three patients and resolved with fluconazole therapy, and there were no significant deviations from projected growth curves for height and weight.
“This is an important clinical trial that demonstrates that swallowed [fluticasone propionate] leads to a sustained long-term remission of EoE in children, defined as a reduction in peak eosinophil counts in the most affected area of the esophagus,” the researchers concluded. “This long-term oral steroid treatment was well tolerated and safe. This is particularly encouraging considering that to date no satisfying alternative long-term treatment options other than significant dietary modifications are available.”
Larger multicenter trials should confirm optimal long-term dosing regimens, they added. – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.
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