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Quality of Life in Eosinophilic Esophagitis
AB234 Abstracts
761
Successful Treatment of Eosinophilic Gastroenteritis with a Multiple-Food Elimination Diet
Yoshiyuki Yamada, MD, PhD1, Yuka Isoda1, Akira Nishi, MD1, Yuko Jinbo1, Satoru Watanabe1,2, Masahiko Kato, MD, PhD, FAAAAI1,3; 1 Gunma Children’s Medical Center, Shibukawa, Gunma, Japan, 2Gunma University Faculty of Medicine School of Health Science, Maebashi, Gunma, Japan, 3Department of Pediatrics, Tokai University School of Medicine, Isehara, Kanagawa, Japan. RATIONALE: Dietary restriction therapies for eosinophilic gastroenteritis (EGE) have been shown to be effective in some studies. We analyzed the effectiveness of a multiple-food elimination diet (MFED), an empiric diet preferentially devoid of the six most common food allergens—milk, soy, egg, wheat, peanuts/tree nuts, and shellfish/fish (6-FED)—and other the patient’s historically causative foods for the treatment of EGE. METHODS: Three patients with EGE who were diagnosed on the basis of gastrointestinal symptoms and eosinophil infiltration of the gastrointestinal _20 eosinophils/high-power field) and were treated with a MFED mucosa (> (for a total of four times) followed by reintroduction of those eliminated foods without systemic steroids at our hospital between 2010 and 2014 were included. Clinical data, including imaging and histological findings, and eosinophil, albumin, immunoglobulin G (IgG), and hemoglobin levels before and after the MFED were retrospectively reviewed and compared. RESULTS: Before the MFED, all patients had a low serum IgG level. A low albumin level and a low hemoglobin level were observed in one patient each. All patients showed an improvement of clinical symptoms and imaging or histological findings; a decrease in the eosinophil level; and an increase in the albumin, IgG, and hemoglobin levels after the MFED. The causative foods identified in the reintroduction phase were cow’s milk and wheat in two patients and soybean and hen’s eggs in one patient each. CONCLUSIONS: The MFED may be a promising alternative treatment to improve clinical findings and laboratory data in patients with EGE.
762
Long-Term Safety and Efficacy of Reslizumab in Children and Adolescents with Eosinophilic Esophagitis: A Review of 477 Doses in 12 Children over 7 Years
MONDAY
Jonathan E. Markowitz1,2, Laura Jobe2, Michelle Miller2, Carrie Frost3, Ransome Eke3; 1Greenville Children’s Hospital, Greenville, SC, 2University of South Carolina School of Medicine-Greenville, Greenville, SC, 3 Greenville Health System, Greenville, SC. RATIONALE: To evaluate the long term safety and efficacy of resilizumab (RSZ), a monoclonal humanized antibody to interleukin-5, in pediatric patients who have received the drug through participation in a randomized controlled trial (RCT), followed by an open-label extension (OLE), and ongoing treatment on a compassionate use (CU) basis. METHODS: Records of patients who received RSZ in our center were reviewed. Patients received RSZ 2 mg/kg (or placebo) every 4 weeks as part of the RCT from March 2008 to October 2009, OLE from July 2008 to January 2012, and CU from January 2012 until July 2015. Labwork, history, and examinations were conducted every 12 weeks. Biopsy results were compared from baseline (prior to RCT) and at the most recent evaluation. Adverse events (AE) were recorded. RESULTS: 12 patients entered the RCT at our center. 6 patients completed the OLE. 4 received RSZ through CU. Between the RCT, OLE, and CU periods, patients received 477 doses of RSZ (mean 40, range 2-89). No serious AE were attributed to RSZ in any phase of administration. No clinically significant laboratory abnormalities were identified. Symptoms improved on treatment: dysphagia (42% vs 9%); abdominal pain (58% vs 0%); heartburn (18% vs 0%); vomiting (67% vs 33%); reflux (58% vs
J ALLERGY CLIN IMMUNOL FEBRUARY 2016
0%). Mean esophageal eosinophil count improved on treatment (33 eos/hpf vs 3). CONCLUSIONS: RSZ appears to be safe in children with eosinophilic esophagitis over 7 years of experience. Symptoms and eosinophil count improved in our patients treated with RSZ.
763
Quality of Life in Eosinophilic Esophagitis
Shreya N. Patel, MD1, John Oppenheimer, MD, FAAAAI1, Tamara Feldman, MD2, Annette Langseder, RN2, Peter Wilmot, MD2, Oren Koslowe, MD2, Joel Rosh, MD2, Maria Perez, MD2, Barbara Verga, MD2, Alycia Leiby, MD2, Neha Pandey, MD2; 1Rutgers-New Jersey Medical School, Newark, NJ, 2Atlantic Health, Goryeb Children’s Hospital, Morristown, NJ. RATIONALE: Eosinophilic esophagitis (EoE) is a chronic immunemediated, esophageal disease. Although change in histology as well as symptom scores following implementation of different treatment modalities have been explored previously, major patient-oriented outcome measures such as quality of life (QoL) have not been well examined in EoE. QoL issues in patients with EoE are distinct and potentially as devastating as those faced by the general food allergy community. We hypothesize that Qol is significantly impeded in patients with EoE. METHODS: The Goryeb Children’s Hospital Department of Gastroenterology recruited one patient to date between the age of 5-18 for a prospective quality of life study. The PedsQLTM as well as the EoEspecific Pediatric QoL Inventory was administered to the child and parent. Active enrollment of patients is currently ongoing. We plan to have at least 20 subjects by the annual meeting. Data will be compared with Qol measurements from healthy controls as obtained from the 2005 study by Youssef, et al. RESULTS: Physical and social functioning was not significantly affected with patient reported overall score of 0 (never have problems with) in each category. While emotional functioning mildly diminished, the most significantly affected category was school functioning with the patient stating that it is often hard to pay attention in school and he often forgets things. CONCLUSIONS: Health related quality of life is an important outcome in clinical trials, clinical improvement strategies and population-based health assessment. We hope to further explore it within the world of EoE at the completion of this study.
761
Successful Treatment of Eosinophilic Gastroenteritis with a Multiple-Food Elimination Diet
Yoshiyuki Yamada, MD, PhD1, Yuka Isoda1, Akira Nishi, MD1, Yuko Jinbo1, Satoru Watanabe1,2, Masahiko Kato, MD, PhD, FAAAAI1,3; 1 Gunma Children’s Medical Center, Shibukawa, Gunma, Japan, 2Gunma University Faculty of Medicine School of Health Science, Maebashi, Gunma, Japan, 3Department of Pediatrics, Tokai University School of Medicine, Isehara, Kanagawa, Japan. RATIONALE: Dietary restriction therapies for eosinophilic gastroenteritis (EGE) have been shown to be effective in some studies. We analyzed the effectiveness of a multiple-food elimination diet (MFED), an empiric diet preferentially devoid of the six most common food allergens—milk, soy, egg, wheat, peanuts/tree nuts, and shellfish/fish (6-FED)—and other the patient’s historically causative foods for the treatment of EGE. METHODS: Three patients with EGE who were diagnosed on the basis of gastrointestinal symptoms and eosinophil infiltration of the gastrointestinal _20 eosinophils/high-power field) and were treated with a MFED mucosa (> (for a total of four times) followed by reintroduction of those eliminated foods without systemic steroids at our hospital between 2010 and 2014 were included. Clinical data, including imaging and histological findings, and eosinophil, albumin, immunoglobulin G (IgG), and hemoglobin levels before and after the MFED were retrospectively reviewed and compared. RESULTS: Before the MFED, all patients had a low serum IgG level. A low albumin level and a low hemoglobin level were observed in one patient each. All patients showed an improvement of clinical symptoms and imaging or histological findings; a decrease in the eosinophil level; and an increase in the albumin, IgG, and hemoglobin levels after the MFED. The causative foods identified in the reintroduction phase were cow’s milk and wheat in two patients and soybean and hen’s eggs in one patient each. CONCLUSIONS: The MFED may be a promising alternative treatment to improve clinical findings and laboratory data in patients with EGE.
762
Long-Term Safety and Efficacy of Reslizumab in Children and Adolescents with Eosinophilic Esophagitis: A Review of 477 Doses in 12 Children over 7 Years
MONDAY
Jonathan E. Markowitz1,2, Laura Jobe2, Michelle Miller2, Carrie Frost3, Ransome Eke3; 1Greenville Children’s Hospital, Greenville, SC, 2University of South Carolina School of Medicine-Greenville, Greenville, SC, 3 Greenville Health System, Greenville, SC. RATIONALE: To evaluate the long term safety and efficacy of resilizumab (RSZ), a monoclonal humanized antibody to interleukin-5, in pediatric patients who have received the drug through participation in a randomized controlled trial (RCT), followed by an open-label extension (OLE), and ongoing treatment on a compassionate use (CU) basis. METHODS: Records of patients who received RSZ in our center were reviewed. Patients received RSZ 2 mg/kg (or placebo) every 4 weeks as part of the RCT from March 2008 to October 2009, OLE from July 2008 to January 2012, and CU from January 2012 until July 2015. Labwork, history, and examinations were conducted every 12 weeks. Biopsy results were compared from baseline (prior to RCT) and at the most recent evaluation. Adverse events (AE) were recorded. RESULTS: 12 patients entered the RCT at our center. 6 patients completed the OLE. 4 received RSZ through CU. Between the RCT, OLE, and CU periods, patients received 477 doses of RSZ (mean 40, range 2-89). No serious AE were attributed to RSZ in any phase of administration. No clinically significant laboratory abnormalities were identified. Symptoms improved on treatment: dysphagia (42% vs 9%); abdominal pain (58% vs 0%); heartburn (18% vs 0%); vomiting (67% vs 33%); reflux (58% vs
J ALLERGY CLIN IMMUNOL FEBRUARY 2016
0%). Mean esophageal eosinophil count improved on treatment (33 eos/hpf vs 3). CONCLUSIONS: RSZ appears to be safe in children with eosinophilic esophagitis over 7 years of experience. Symptoms and eosinophil count improved in our patients treated with RSZ.
763
Quality of Life in Eosinophilic Esophagitis
Shreya N. Patel, MD1, John Oppenheimer, MD, FAAAAI1, Tamara Feldman, MD2, Annette Langseder, RN2, Peter Wilmot, MD2, Oren Koslowe, MD2, Joel Rosh, MD2, Maria Perez, MD2, Barbara Verga, MD2, Alycia Leiby, MD2, Neha Pandey, MD2; 1Rutgers-New Jersey Medical School, Newark, NJ, 2Atlantic Health, Goryeb Children’s Hospital, Morristown, NJ. RATIONALE: Eosinophilic esophagitis (EoE) is a chronic immunemediated, esophageal disease. Although change in histology as well as symptom scores following implementation of different treatment modalities have been explored previously, major patient-oriented outcome measures such as quality of life (QoL) have not been well examined in EoE. QoL issues in patients with EoE are distinct and potentially as devastating as those faced by the general food allergy community. We hypothesize that Qol is significantly impeded in patients with EoE. METHODS: The Goryeb Children’s Hospital Department of Gastroenterology recruited one patient to date between the age of 5-18 for a prospective quality of life study. The PedsQLTM as well as the EoEspecific Pediatric QoL Inventory was administered to the child and parent. Active enrollment of patients is currently ongoing. We plan to have at least 20 subjects by the annual meeting. Data will be compared with Qol measurements from healthy controls as obtained from the 2005 study by Youssef, et al. RESULTS: Physical and social functioning was not significantly affected with patient reported overall score of 0 (never have problems with) in each category. While emotional functioning mildly diminished, the most significantly affected category was school functioning with the patient stating that it is often hard to pay attention in school and he often forgets things. CONCLUSIONS: Health related quality of life is an important outcome in clinical trials, clinical improvement strategies and population-based health assessment. We hope to further explore it within the world of EoE at the completion of this study.