Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2009 |
Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea,
epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal
symptoms along with obstructive esophageal symptoms in both pediatric and adult population.
The pathology of this disease is postulated to be allergy mediated and the incidence of this
disease is seen to parallel an increase in the incidence of allergies and asthma.
Most of the current therapies for EoE are directed at decreasing esophageal allergic
inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids
and elimination diets or elemental diets have shown variable efficacy is improving symptoms.
However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no
definitive treatment that completely resolves symptoms and histological findings. Omalizumab
is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled
and oral corticosteroids and improve asthma related symptoms in patients with allergic
asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study
the mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms
clinically, and histological changes (and improvements) in response to treatment with Xolair
(omalizumab) in patients suffering from EoE will be determined. The primary objective of
this open label, study is to determine mucosal markers that will predict responders to
Omalizumab (Xolair).
This is an open label mechanistic study to learn about the effect of Omalizumab on the
clinical symptoms and immunohistological findings in established cases of EoE. The dosage
for Omalizumab will be based on patient's body weight and baseline IgE level. Omalizumab
will be administered subcutaneously every 2 or 4 weeks for total duration of 12 weeks. At
enrollment, subjects will have EGD with biopsies performed to confirm diagnosis of EoE and
further histologic analysis and special staining. Blood will be drawn for baseline testing
and monthly for safety labs. At the end of the 12 week period, repeat endoscopy will be
performed and biopsies taken to stain again for various mucosal markers like IgE, IL-13,
IL-5 and Tryptase. The patients will be followed for response to therapy with regards to
resolution of symptoms and improvement in histology findings on biopsy.
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