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Su1842 Dietary Elimination Therapy Is an Effective Option for Adults With Eosinophilic Esophagitis
AGA Abstracts
of dysphagia and esophageal eosinophilia ( ≥15eos/hpf); concurrent treatment was allowed as clinically indicated. The number of solid-food-avoidance days, number of dysphagia days, actions taken to get relief, and compliance with the instrument were recorded. A dysphagia score was calculated and compared to the number of dysphagia days per week as well as to the frequency component of the Straumann Dysphagia Instrument (SDI) previously used in a clinical trial of budesonide. Results: A total of 10 adolescents and 10 adults were included in the first phase for development of the Dysphagia Symptom Questionnaire (DSQ). This was a daily electronic diary completed on a handheld device asking 3 questions: 1) did the subject eat solid food; 2) if so, did food go down slowly or get stuck; 3) and if so, did the subject do anything to get relief. In the second phase, 35 subjects finished the field trial (18 adults, 17 adolescents, mean age 24, 54% male, 95% white, 51% currently on topical corticosteroids). Compliance was good, with subjects completing 83% of total eligible days. Nine subjects (26%) reported at least one day of solid food avoidance; there were 32 total solid food avoidance days (3% of eligible study days). The median number of dysphagia days/wk was 1 for adolescents and 3.5 for adults; the number was 1.5 for those on topical steroids and 3.5 for those not on topical steroids. The calculated DSQ score strongly correlated with the number of dysphagia days (R=0.96; p ,0.001) and the SDI (R=0.77; p ,0.001) (Figures). Conclusions: The DSQ, a 3-question electronic patient reported outcome, was successfully developed and field tested. The DSQ had content validity, the score accurately measured dysphagia frequency and intensity, and was able to distinguish those treated and not treated with topical corticosteroids. The DSQ is suitable for use in clinical trials of EoE patients with dysphagia. This research was designed and conducted with support and input from Meritage Pharma.
Su1842 Dietary Elimination Therapy Is an Effective Option for Adults With Eosinophilic Esophagitis W. Asher Wolf, Maya R. Jerath, Sarah McConville, Nicholas J. Shaheen, Evan S. Dellon Background: Eosinophilic esophagitis (EoE) is an immune-mediated disorder which can be triggered by food allergens. While food elimination is a well-established treatment for children with EoE, data supporting this approach in adults are less extensive. Aim: To determine the clinical and histologic response rates of adults with EoE who were treated with dietary elimination therapy. Methods: This was a retrospective study of the University of North Carolina EoE Clinicopathologic database from 2006-2012. For inclusion, subjects had to be at least 18 years of age, have EoE as per consensus guidelines (symptoms of esophageal dysfunction and ≥15 eosinophils in at least one high-power microscopy field (hpf area= 0.24 mm2) while on high dose acid suppression), and have undergone dietary elimination therapy. Patients started simultaneously on a swallowed steroid and dietary therapy were excluded. Data were extracted from chart review. Outcomes were symptom response (patientreported subjective improvement), endoscopic improvement (endoscopist-reported), and histologic remission (,15 eos/hpf) or response ( .50% decrease in eos/hpf). Response to dietary therapy was also compared to the response to swallowed steroids in patients who received each therapy but at separate times. Results: A total of 26 adults underwent dietary therapy (mean age 35 years, range 19-50; 46% male; 92% white; baseline maximum eosinophil count 75 eos/hpf, range 15-300). Of these, 6 had a six-food elimination diet (SFED) and 20 had a targeted elimination diet (Table). The overall symptom response rate was 62%, 67% with SFED and 60% with targeted (p=ns). 22 subjects underwent follow-up endoscopy, and the endoscopic appearance was improved in 59% overall, 80% with SFED and 53% for targeted (p=ns). After dietary therapy, the mean eosinophil count decreased to 40 eos/hpf (p=0.03). Eight subjects (36%) had a histologic remission and 13 (59%) had .50% drop in eosinophil counts; histologic improvement did not vary by diet type. There were no differences in histologic remission by age, gender, race, atopic status, or baseline eosinophil counts. A total of 8 subjects had foods reintroduced, and the most common triggers were dairy (50%), wheat (38%), nuts (38%), and seafood (38%). Overall, rates of response to dietary elimination were similar to rates for topical steroid therapy (n = 20 treated; 50% symptom response; 65% endoscopic improvement; 53% histologic remission; p=ns for all). Conclusions: Dietary elimination was a successful treatment modality for adults with EoE. Response rates were similar for dietary and steroid therapy in this patient population. Because the choice to pursue dietary therapy will depend on factors such as patient preference and cost, further research should emphasize which factors can predict effective dietary therapy. Characteristics of patients treated with dietary and steroid therapy
Su1841 A Training Curriculum for Pathologists Yields Highly Reproducible Esophageal Eosinophil Counts Olga Speck, Kimberly Woodward, Shannon Covey, John T. Woosley, Nicholas J. Shaheen, Evan S. Dellon Background: Eosinophilic esophagitis (EoE) is characterized by infiltration of the esophageal epithelium with eosinophils. The majority of studies on EoE are from referral centers with expert pathology review, but it is unknown whether pathology trainees can reliably determine esophageal eosinophil counts. Aim: To assess the inter-observer reliability of esophageal eosinophil counts by pathology residents after a training session and with use of a standardized case set. Methods: This was a retrospective study of the University of North Carolina EoE Clinicopathologic database. A set of 40 digitized histology H&E slides from patients with varying degrees of esophageal eosinophils (from 0 to 400 eos/hpf) was utilized as the training case set. Each of three resident pathologists underwent a single teaching session focused on quantifying eosinophil counts and characterizing other EoE findings including eosinophil microabscesses, degranulation, spongiosis, and lamina propria fibrosis. Then, following our previously validated protocol, each evaluated 5 hpfs per slide for all of the specimens in the training set. The maximum eosinophil count (eos/hpf) was calculated from the eosinophil density (eos/mm2) assuming a hpf size of 0.24mm2. The same slide set had previously been independently evaluated by three expert pathologists. The mean of the maximum eosinophil counts from the experts was treated as the gold standard count for this study, and was correlated with the trainee counts. Agreement was also calculated for the diagnostic threshold of 15 eos/hpf. Results: The correlation coefficient for each of the three trainee pathologists was R=0.87, R=0.89, and R=0.92 respectively when compared with the gold standard count (p,0.001 for all). The trainee pathologists were also highly correlated with each other (pathologist 1 vs 2, R=0.83; pathologist 1 vs 3, R=0.84; pathologist 2 vs 3, R=0.86; p ,0.001 for all). Agreement was excellent for determining if a count was above or below the diagnostic threshold (K=0.83, K=0.89, K=0.88, respectively; p ,0.001 for all). Agreement was in the good range for eosinophil microabscesses (K=0.54, K=0.64, K=0.46, respectively; p ,0.01 for all) and eosinophil degranulation (K=0.45, K=0.67, K=0.63, respectively; p ,0.01 for all). For spongiosis, agreement was good to excellent (K=0.82, K=0.72, K=0.44, respectively; p,0.01 for all). Less than half of samples had lamina propria present, so agreements could not be calculated for lamina propria fibrosis. Conclusions: Using a training session, a standardized digitized slide set, and validated counting protocol, the agreement between pathology trainees and expert pathologists for determining eosinophil counts was excellent. Agreement was good to excellent for eosinophil microabscesses, degranulation, and spongiosis. Pathology residents can be important collaborators in EoE research.
AGA Abstracts
S-488
of dysphagia and esophageal eosinophilia ( ≥15eos/hpf); concurrent treatment was allowed as clinically indicated. The number of solid-food-avoidance days, number of dysphagia days, actions taken to get relief, and compliance with the instrument were recorded. A dysphagia score was calculated and compared to the number of dysphagia days per week as well as to the frequency component of the Straumann Dysphagia Instrument (SDI) previously used in a clinical trial of budesonide. Results: A total of 10 adolescents and 10 adults were included in the first phase for development of the Dysphagia Symptom Questionnaire (DSQ). This was a daily electronic diary completed on a handheld device asking 3 questions: 1) did the subject eat solid food; 2) if so, did food go down slowly or get stuck; 3) and if so, did the subject do anything to get relief. In the second phase, 35 subjects finished the field trial (18 adults, 17 adolescents, mean age 24, 54% male, 95% white, 51% currently on topical corticosteroids). Compliance was good, with subjects completing 83% of total eligible days. Nine subjects (26%) reported at least one day of solid food avoidance; there were 32 total solid food avoidance days (3% of eligible study days). The median number of dysphagia days/wk was 1 for adolescents and 3.5 for adults; the number was 1.5 for those on topical steroids and 3.5 for those not on topical steroids. The calculated DSQ score strongly correlated with the number of dysphagia days (R=0.96; p ,0.001) and the SDI (R=0.77; p ,0.001) (Figures). Conclusions: The DSQ, a 3-question electronic patient reported outcome, was successfully developed and field tested. The DSQ had content validity, the score accurately measured dysphagia frequency and intensity, and was able to distinguish those treated and not treated with topical corticosteroids. The DSQ is suitable for use in clinical trials of EoE patients with dysphagia. This research was designed and conducted with support and input from Meritage Pharma.
Su1842 Dietary Elimination Therapy Is an Effective Option for Adults With Eosinophilic Esophagitis W. Asher Wolf, Maya R. Jerath, Sarah McConville, Nicholas J. Shaheen, Evan S. Dellon Background: Eosinophilic esophagitis (EoE) is an immune-mediated disorder which can be triggered by food allergens. While food elimination is a well-established treatment for children with EoE, data supporting this approach in adults are less extensive. Aim: To determine the clinical and histologic response rates of adults with EoE who were treated with dietary elimination therapy. Methods: This was a retrospective study of the University of North Carolina EoE Clinicopathologic database from 2006-2012. For inclusion, subjects had to be at least 18 years of age, have EoE as per consensus guidelines (symptoms of esophageal dysfunction and ≥15 eosinophils in at least one high-power microscopy field (hpf area= 0.24 mm2) while on high dose acid suppression), and have undergone dietary elimination therapy. Patients started simultaneously on a swallowed steroid and dietary therapy were excluded. Data were extracted from chart review. Outcomes were symptom response (patientreported subjective improvement), endoscopic improvement (endoscopist-reported), and histologic remission (,15 eos/hpf) or response ( .50% decrease in eos/hpf). Response to dietary therapy was also compared to the response to swallowed steroids in patients who received each therapy but at separate times. Results: A total of 26 adults underwent dietary therapy (mean age 35 years, range 19-50; 46% male; 92% white; baseline maximum eosinophil count 75 eos/hpf, range 15-300). Of these, 6 had a six-food elimination diet (SFED) and 20 had a targeted elimination diet (Table). The overall symptom response rate was 62%, 67% with SFED and 60% with targeted (p=ns). 22 subjects underwent follow-up endoscopy, and the endoscopic appearance was improved in 59% overall, 80% with SFED and 53% for targeted (p=ns). After dietary therapy, the mean eosinophil count decreased to 40 eos/hpf (p=0.03). Eight subjects (36%) had a histologic remission and 13 (59%) had .50% drop in eosinophil counts; histologic improvement did not vary by diet type. There were no differences in histologic remission by age, gender, race, atopic status, or baseline eosinophil counts. A total of 8 subjects had foods reintroduced, and the most common triggers were dairy (50%), wheat (38%), nuts (38%), and seafood (38%). Overall, rates of response to dietary elimination were similar to rates for topical steroid therapy (n = 20 treated; 50% symptom response; 65% endoscopic improvement; 53% histologic remission; p=ns for all). Conclusions: Dietary elimination was a successful treatment modality for adults with EoE. Response rates were similar for dietary and steroid therapy in this patient population. Because the choice to pursue dietary therapy will depend on factors such as patient preference and cost, further research should emphasize which factors can predict effective dietary therapy. Characteristics of patients treated with dietary and steroid therapy
Su1841 A Training Curriculum for Pathologists Yields Highly Reproducible Esophageal Eosinophil Counts Olga Speck, Kimberly Woodward, Shannon Covey, John T. Woosley, Nicholas J. Shaheen, Evan S. Dellon Background: Eosinophilic esophagitis (EoE) is characterized by infiltration of the esophageal epithelium with eosinophils. The majority of studies on EoE are from referral centers with expert pathology review, but it is unknown whether pathology trainees can reliably determine esophageal eosinophil counts. Aim: To assess the inter-observer reliability of esophageal eosinophil counts by pathology residents after a training session and with use of a standardized case set. Methods: This was a retrospective study of the University of North Carolina EoE Clinicopathologic database. A set of 40 digitized histology H&E slides from patients with varying degrees of esophageal eosinophils (from 0 to 400 eos/hpf) was utilized as the training case set. Each of three resident pathologists underwent a single teaching session focused on quantifying eosinophil counts and characterizing other EoE findings including eosinophil microabscesses, degranulation, spongiosis, and lamina propria fibrosis. Then, following our previously validated protocol, each evaluated 5 hpfs per slide for all of the specimens in the training set. The maximum eosinophil count (eos/hpf) was calculated from the eosinophil density (eos/mm2) assuming a hpf size of 0.24mm2. The same slide set had previously been independently evaluated by three expert pathologists. The mean of the maximum eosinophil counts from the experts was treated as the gold standard count for this study, and was correlated with the trainee counts. Agreement was also calculated for the diagnostic threshold of 15 eos/hpf. Results: The correlation coefficient for each of the three trainee pathologists was R=0.87, R=0.89, and R=0.92 respectively when compared with the gold standard count (p,0.001 for all). The trainee pathologists were also highly correlated with each other (pathologist 1 vs 2, R=0.83; pathologist 1 vs 3, R=0.84; pathologist 2 vs 3, R=0.86; p ,0.001 for all). Agreement was excellent for determining if a count was above or below the diagnostic threshold (K=0.83, K=0.89, K=0.88, respectively; p ,0.001 for all). Agreement was in the good range for eosinophil microabscesses (K=0.54, K=0.64, K=0.46, respectively; p ,0.01 for all) and eosinophil degranulation (K=0.45, K=0.67, K=0.63, respectively; p ,0.01 for all). For spongiosis, agreement was good to excellent (K=0.82, K=0.72, K=0.44, respectively; p,0.01 for all). Less than half of samples had lamina propria present, so agreements could not be calculated for lamina propria fibrosis. Conclusions: Using a training session, a standardized digitized slide set, and validated counting protocol, the agreement between pathology trainees and expert pathologists for determining eosinophil counts was excellent. Agreement was good to excellent for eosinophil microabscesses, degranulation, and spongiosis. Pathology residents can be important collaborators in EoE research.
AGA Abstracts
S-488