title: A pilot study of omalizumab in eosinophilic esophagitis.
abstract: Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE), once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE) levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy.
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Amerimmune, Fairfax, VA, United States of America.
authors: Denise
authors: D
authors: Loizou
authors: Pediatric Gastroenterology of Northern Virginia, Lorton, VA, United States of America.
authors: Benjamin
authors: B
authors: Enav
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Lysosomal Storage Disorders Section, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Edina
authors: E
authors: Komlodi-Pasztor
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Lysosomal Storage Disorders Section, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Pamela
authors: P
authors: Hider
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Julie
authors: J
authors: Kim-Chang
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Laura
authors: L
authors: Noonan
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Lysosomal Storage Disorders Section, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Tabitha
authors: T
authors: Taber
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Suhasini
authors: S
authors: Kaushal
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Lysosomal Storage Disorders Section, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Renuka
authors: R
authors: Limgala
authors: Amerimmune, Fairfax, VA, United States of America.
authors: Margaret
authors: M
authors: Brown
authors: Amerimmune, Fairfax, VA, United States of America.
authors: Raavi
authors: R
authors: Gupta
authors: Gastroenterology Associates of Northern Virginia, Fairfax, VA, United States of America.
authors: Nader
authors: N
authors: Balba
authors: Lysosomal Storage Disorders Section, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Ozlem
authors: O
authors: Goker-Alpan
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America.
authors: Amer
authors: A
authors: Khojah
authors: Section on Immunopathogenesis, Food Allergy and Eosinophilic Disorders Program, O&O ALPAN, LLC, Fairfax, VA, United States of America; Amerimmune, Fairfax, VA, United States of America.
authors: Oral
authors: O
authors: Alpan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D002648:Child; D057765:Eosinophilic Esophagitis / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D004804:Eosinophils / Q000378:metabolism / Q000473:pathology; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007958:Leukocyte Count; D008297:Male; D000069444:Omalizumab / Q000008:administration & dosage*
chemical_list: D018926:Anti-Allergic Agents; D000069444:Omalizumab; D007073:Immunoglobulin E