Long-Term Treatment of Eosinophilic Esophagitis with Budesonide Oral Suspension.
We evaluated treatment withdrawal, long-term outcomes and safety of budesonide oral suspension (BOS) 2.0 mg b.i.d. in patients with eosinophilic esophagitis who completed a 12-week induction study.Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] score) to BOS 2.0 mg b.i.d. (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- and non-responders, and patients who received induction placebo, received BOS for 36 weeks. The primary endpoint was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [DSQ] over 2 weeks) by week 36. The key secondary endpoint was the proportion of induction partial- and non-responders who fully responded after 52 weeks’ total BOS therapy. Secondary endpoints included: proportion of induction full responders with histologic responses (≤1, ≤6, <15 eos/hpf) at week 12 of the extension study, and safety outcomes.The randomized withdrawal period enrolled 48 patients (BOS-BOS, n=25; BOS-PBO, n=23); 106 induction partial- and non-responders and 65 induction placebo patients received BOS. More BOS-PBO than BOS-BOS patients relapsed over 36 weeks (43.5% vs 24.0%; P=.131) and had histologic responses at week 12 of therapy (P
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Authors: 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, ORBIT2/SHP621-302 investigators