A RANDOMIZED CONTROLLED TRIAL COMPARING SIX-FOOD ELIMINATION DIET VS TOPICAL STEROIDS IN INDUCING AND MAINTAINING REMISSION OF PEDIATRIC EOSINOPHILIC ESOPHAGITIS

Background and aims The current guidelines recommend topical steroids (fluticasone or budesonide) or elimination diet as first-line treatment for EoE. Unfortunately, there are no data comparing directly these therapies in children. The aims of this study is to assess the efficacy of 6-food elimination diet (SFED) and topical steroids in inducing and maintaining remission of pediatric EoE. Methods We prospectively enrolled active pediatric EoE patients during 2 years. At baseline children were randomized in four different treatments: SFED, swallowed fluticasone (SF), swallowed budesonide (SB) and oral viscous budesonide (OVB). The short- and long-term efficacy of each treatment was assessed by the percentage of responders (<15/HPF of peak eosinophil count) after the induction therapy (8 weeks) and at the end of the study period (42 weeks). In the diet group, patients achieving remission after 8 weeks underwent systematic reintroduction of foods followed by endoscopy and biopsies, to identify the trigger foods. Whereas patients in remission with steroids continued the induction therapy until 12 weeks, before interrupting. In these patients, a second endoscopy could be performed between 26 and 30 weeks in case of symptomatic relapse. Patients with a histological flare-up were considered for a new treatment cycle with the same steroid of induction. All the patients received a final endoscopy at 42 weeks. Clinical symptom score (CSS), endoscopy (EREFS score) and histology (count of eosinophils/hpf at all esophageal levels) were evaluated at 0, 8 and 42 weeks. Results Of 74 patients evaluated, 64 were enrolled, but 50 completed the study and were considered for the final analysis. After induction therapy (8 weeks) the percentages of responders were 69%, 67%, 75% and 85% in the SFED, SF, SB and OVB, respectively. All treatments were able to significantly reduce the mean peak eosinophilic count compared to baseline (p<0.05). At the end of the study, the percentages of patients maintaining remission were 61%, 42%, 33% and 38% in the SFED, SF, SB and OVB, respectively. However, including and analyzing also patients receiving a second steroids cycle at week 26-30 for a flare-up, the percentages of remission increased to 75%,75% and 85% in the SF, SB and OVB, respectively (Figure). Based on reintroduction in the SFED group, the foods most frequently associated with EoE were milk (78% of cases) and egg (56% of cases). Conclusions This first pediatric, randomized controlled study on four different treatments shows that diet and topical steroids are both effective in inducing remission in pediatric EoE. Almost all children responders to diet maintained remission in the long-term follow-up by identifying the trigger foods. Topical steroids seem to have a higher efficacy in the short-term, but requires repeated cycles to maintain long-term remission.