A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 12 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | November 2005 |
| End Date: | January 2010 |
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by
dysphagia, food impaction or other obstructive esophageal symptoms in children and young
adults.
The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and
family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic
rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising
incidence of EE may be related to the worldwide allergy and asthma epidemic.
Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and
topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have
all been shown to be effective. However, none of these treatments are directed at the
specific pathophysiologic mechanism of EE and some have significant side effects.
The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies
directed at asthma may also be effective for EE. Specifically those targeted at the allergic
immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed
anti-IgE antibody that has been shown to decrease the use of inhaled and oral
corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related
symptoms in patients with allergic asthma. The objective of the study is to determine the
efficacy of omalizumab in the treatment of eosinophilic esophagitis
dysphagia, food impaction or other obstructive esophageal symptoms in children and young
adults.
The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and
family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic
rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising
incidence of EE may be related to the worldwide allergy and asthma epidemic.
Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and
topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have
all been shown to be effective. However, none of these treatments are directed at the
specific pathophysiologic mechanism of EE and some have significant side effects.
The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies
directed at asthma may also be effective for EE. Specifically those targeted at the allergic
immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed
anti-IgE antibody that has been shown to decrease the use of inhaled and oral
corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related
symptoms in patients with allergic asthma. The objective of the study is to determine the
efficacy of omalizumab in the treatment of eosinophilic esophagitis
This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment
of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE
level. Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks.
At study entry subjects will have EGD with biopsies performed to ensure the diagnosis and
obtain tissue for histologic analysis. No dilation will be performed at this time. Baseline
validated questionnaires for dysphagia, GERD, and atopy will also be administered. Blood
will be drawn for baseline serum testing. Repeat questionnaires and rating of overall
symptom improvement will be administered at 4 week intervals for the rest of the study
period. At the end of the 16 week period, repeat endoscopy will be performed and biopsies
taken. Esophageal dilation may be performed if clinically indicated at this time. Blood will
also be drawn for repeat serum testing.
of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE
level. Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks.
At study entry subjects will have EGD with biopsies performed to ensure the diagnosis and
obtain tissue for histologic analysis. No dilation will be performed at this time. Baseline
validated questionnaires for dysphagia, GERD, and atopy will also be administered. Blood
will be drawn for baseline serum testing. Repeat questionnaires and rating of overall
symptom improvement will be administered at 4 week intervals for the rest of the study
period. At the end of the 16 week period, repeat endoscopy will be performed and biopsies
taken. Esophageal dilation may be performed if clinically indicated at this time. Blood will
also be drawn for repeat serum testing.
Inclusion Criteria:
- Male or female subjects aged 12-60 years of age with EE as defined above
- Serum IgE level 30-700 IU/mL
- Subjects with acceptable medical history, physical exam and laboratory test results
- No history of bleeding diathesis, significant cardiopulmonary disease, or other
contraindication to upper endoscopy
Exclusion Criteria:
- Need for esophageal dilation at enrollment due to food impaction or inability to pass
endoscope
- Inability of subject to provide informed consent (if ages 18-60), or inability of
children (ages 12-17) to provide assent
- History of esophagogastric surgery
- Presence of other esophageal pathology that could account for patients' symptoms
including eosinophil infiltration due to gastroesophageal reflux disease (GERD)
- Incarceration
- Pregnancy
- Women of childbearing potential not using the contraception method(s)
- Patients with elevated serum IgE levels for reasons other than atopy
- Patients taking cromolyn sodium or nedocromil sodium within 1 month of visit 1
- Patients taking oral or topical corticosteroids within one month of visit 1
- Patients taking leukotriene receptor inhibitors within one month of visit 1
- Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study
- Patients with a history of noncompliance to medical regimens or who were considered
potentially unreliable
- Use of any other investigational agent in the last 30 days
- Patients with a known hypersensitivity to any ingredient of rhuMAb-E25, study rescue
medication
- Patients with Barrett's esophagus will be excluded if found endoscopically or
pathologically at biopsy
- Currently treated with omalizumab or treated with omalizumab within the past 6
months.
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