1. Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension
- Author
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Evan S. Dellon, Margaret H. Collins, David A. Katzka, Vincent A. Mukkada, Gary W. Falk, Robin Morey, Bridgett Goodwin, Jessica D. Eisner, Lan Lan, Nirav K. Desai, James Williams, Ikuo Hirano, Curtis Baum, Pradeep Bekal, David Chaletsky, Mirna Chehade, Larry Clark, Evan Dellon, Reed Dimmitt, David Dulitz, Gary Falk, Ronald Fogel, Keith Friedenberg, Scott Gabbard, Andrew Gentry, Benjamin Gold, Michael Goldstein, Sandeep Gupta, Karen Hsu-Blatman, Vikram Jayanty, David Katzka, Vidhya Kunnathur, John Lee, John Leung, Jonathan Markowitz, Calies Menard-Katcher, Benjamin Mitlyng, Sam E. Moussa, Vincent Mukkada, Molly O’Gorman, Juan Olazagasti, Timothy Ritter, Wael Sayej, Shauna Schroeder, Yamen Smadi, Daniel Soteres, Theodore Stathos, Michael F. Vaezi, Tom Whitlock, John Wo, Ziad Younes, and Salam Zakko
- Subjects
Budesonide ,medicine.medical_specialty ,Long term treatment ,Anti-Inflammatory Agents ,Administration, Oral ,Placebo ,Gastroenterology ,Double-Blind Method ,Suspensions ,Maintenance therapy ,Internal medicine ,Eosinophilia ,medicine ,Clinical endpoint ,Humans ,Therapy duration ,Eosinophilic esophagitis ,Hepatology ,business.industry ,Eosinophilic Esophagitis ,medicine.disease ,Dysphagia ,Enteritis ,humanities ,Treatment Outcome ,Gastritis ,medicine.symptom ,Deglutition Disorders ,business ,medicine.drug - Abstract
BACKGROUND & AIMS We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study. METHODS Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6
- Published
- 2022