METHODS OF TREATING EOSINOPHILIC ESOPHAGITIS
The present disclosure provides methods of treating inflammation of the upper gastrointestinal tract, especially the esophagus, by administering an oral corticosteroid. In some cases, the methods include treating eosinophilic esophagitis (EoE) by administering an oral corticosteroid in an induction phase and a maintenance phase to improve peak eosinophilic counts and symptoms. In embodiments, the methods include treating EoE by administering the oral corticosteroid at nighttime and/or while the patient is lying down.
1 . A method of topically treating eosinophilic esophagitis (EoE) in a patient in need thereof, comprising administering an effective amount of budesonide in an induction phase and a maintenance phase, wherein:
an induction dose of about 1 mg to about 2 mg of budesonide is administered in the induction phase; and
a maintenance dose of about 0.5 mg to about 1 mg of budesonide is administered in the maintenance phase.
2 . The method of claim 1 , wherein the induction dose is about 1 mg or about 2 mg of budesonide.
3 . The method of claim 1 , wherein the maintenance dose is about 0.5 mg or about 1 mg of budesonide.
4 . The method of claim 1 , wherein the total daily dose of budesonide administered in the induction phase is about 2 mg.
5 . The method of claim 1 , wherein the total daily dose of budesonide administered in the maintenance phase is about 1 mg.
6 . The method of claim 1 , wherein the induction dose is greater than the maintenance dose.
7 . The method of claim 1 , wherein the induction dose is administered twice a day (b.i.d).
8 . The method of claim 1 , wherein the maintenance dose is administered twice a day (b.i.d).
9 . The method of claim 1 , wherein the induction phase lasts between about 1 and about 12 weeks.
10 . The method of claim 1 , wherein the induction phase results in improvement in peak eosinophilic counts in at least one esophageal biopsy and/or no worsening of symptoms.
11 . The method of claim 1 , wherein after the induction phase the patient experiences esophageal inflammation.
12 . The method of claim 1 , wherein the induction phase results in reduction of esophageal inflammation measured by one or more of a reduction in eosinophil count, an increase in dysphagia-free days, a reduction in episodes of dysphagia, improvement in EREFS score, EndoFLIP documentation of improved esophageal compliance, evaluation of biomarkers, a decrease in episodes of food impaction, an improvement in EEsAI scores (patient, physician, endoscopy, pathology scores), EoE-QOL-A, Visual Dysphagia Questionnaire (VDQ), Avoidance Modification and Slow Eating (AMS) scores, or histology.
13 . The method of claim 1 , wherein the corticosteroid is formulated as a solid composition.
14 . The method of claim 13 , wherein the solid composition is an effervescent tablet.
15 . A method of topically treating eosinophilic esophagitis (EoE) in a patient in need thereof, the method comprising:
administering at least one induction dose of budesonide in an amount of about 1 mg to about 2 mg during an induction phase; and based upon patient response, subsequently administering at least one maintenance dose of budesonide in an amount of about 0.5 mg to about 1 mg during maintenance phase.
16 . The method of claim 15 , wherein after the induction phase, the patient suffers from esophageal inflammation, and then administers at least one maintenance dose of budesonide.
17 . The method of claim 15 , wherein the induction dose is about 1 mg or about 2 mg of budesonide.
18 . The method of claim 15 , wherein the maintenance dose is about 0.5 mg or about 1 mg.
19 . The method of claim 15 , wherein the total daily dose of budesonide administered in the induction phase is about 2 mg.
20 . The method of claim 15 , wherein the total daily dose of budesonide administered in the maintenance phase is about 1 mg.
21 . The method of claim 15 , wherein the induction dose is greater than the maintenance dose.
22 . The method of claim 15 , wherein the induction dose is administered twice a day (b.i.d.).
23 . The method of claim 15 , wherein the maintenance dose is administered twice a day (b.i.d.).
24 . The method of claim 15 , wherein the induction phase lasts between about 1 and about 12 weeks.
25 . The method of claim 15 , wherein the maintenance dose is administered after recurrence of active symptoms of EoE.
26 . The method of claim 15 , wherein after the induction phase, the patient exhibits active symptoms of EoE.
27 . The method of claim 15 , wherein after the induction phase the patient experiences esophageal inflammation.
28 . The method of claim 15 , wherein the budesonide is administered in an effervescent tablet.