Prospective, comparative effectiveness trial of cow's milk elimination and swallowed fluticasone for pediatric eosinophilic esophagitis

Abstract

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated disease in which food antigens play a key role. Current therapeutic options are limited to long-term steroid medication and dietary elimination of multiple foods, each of which is challenging. Our objective was to compare single food elimination of cow's milk to swallowed fluticasone in pediatric EoE patients. This is a prospective, comparative effectiveness trial of newly diagnosed EoE patients (ages 2-18 years) treated with swallowed fluticasone (n = 24) or elimination of cow's milk (n = 20). The dual outcome measures of repeat esophageal biopsy (6-8 weeks) and change in Pediatric Quality of Life Inventor (PedsQL) EoE Module and Symptoms Scales were used to assess response to treatment. After 6-8 weeks of treatment, peak esophageal eosinophil counts decreased to below the threshold of 15 eosinophils/high-power field in 64% of patients treated with cow's milk elimination and 80% of patients treated with swallowed fluticasone (P = 0.4). Mean PedsQL EoE Module total scores (69 vs. 82; P < 0.005) and Total Symptoms scores (58 vs. 75; P = 0.001) showed significant improvement with cow's milk elimination. Among children treated with swallowed fluticasone, mean PedsQL EoE Module total scores (64 vs. 75; P < 0.05) and Total Symptoms scores (58 vs. 69; P < 0.01) were also significantly improved after 6-8 weeks of therapy. Removal of cow's milk from the diet is an effective single food elimination treatment for pediatric patients with EoE as assessed by statistically significant histologic and symptomatic improvement. Cow's milk elimination may be more desirable for EoE patients who do not want to take chronic, long-term steroid medications.

IgE Antibody Detection and Component Analysis in Patients with Eosinophilic Esophagitis

“…23 We prospectively observed children treated with PPI and single food elimination of cow's milk, and we found that 64% had remission based on having esophageal count <15/hpf after 6-8 weeks of treatment. 24 In that study, successful responses to cow's milk avoidance did not relate to the presence of IgE antibodies (Unpublished data).…”

The Developmental History of IgE and IgG4 Antibodies in Relation to Atopy, Eosinophilic Esophagitis, and the Modified TH2 Response

“…Several studies have suggested that cow's milk proteins play a major role. Indeed 60–65 % of children achieve a histological remission with avoidance of cow's milk proteins alone [27]. On the other hand, confusing results have come from assays of IgE to specific cow's milk proteins using Immuno Solid-phase Allergen Chip (ISAC) for IgE [28].…”

Eosinophilic esophagitis: New insights in pathogenesis and therapy

“…It is conceivable that in some patients, as it occurs with other forms of therapy, the lack of correlation between reductions in the eosinophilic infiltration in the esophagus and symptomatic improvement after an elemental diet may be due to presence of esophageal remodeling and sub-epithelial fibrosis that may not respond to the treatment during the relatively short period of these clinical trials [97] . A more practical and acceptable treatment was conducted in a prospective trial comparing swallowed fluticasone and elimination of cow's milk [98] . After 6-8 wk, esophageal eosinophil counts decreased in 64% of patients treated with cow's milk elimination and 80% of patients treated with fluticasone.…”

“…Cow's milk elimination also significantly improved the Mean pediatric quality of life (PedsQL) EoE Module total scores and total symptoms scores. Cow's milk elimination may be more acceptable and desirable for EoE patients who do not want to take chronic, long-term steroid medications [98] . The benefits of dietary restrictions is further supported by the reduction in the number of mast cells and its proteases since these cells seem to play a role in the pathophysiology and symptoms of EoE [99] .…”