Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis  Evan S. Dellon, David A. Katzka, Margaret H. Collins, Sandeep K. Gupta, Lan Lan, James Williams, Ikuo Hirano  Clinical Gastroenterology and Hepatology  Volume 17, Issue 4, Pages 666-673.e8 (March 2019) DOI: 10.1016/j.cgh.2018.05.051 Copyright © 2019 AGA Institute Terms and Conditions

Figure 1 Patient flow during the 24-week open-label extension (OLE). aReasons for study discontinuation: worsening dysphagia (n = 1); severe nausea (n = 1); and vertigo (n = 1). bSponsor decision included administrative reasons and study termination by the sponsor. cOne patient decreased dose to 1.5 mg once daily (QD) and 1 increased to 1.6 mg bis in die (BID). dOne patient decreased dose to 1.0 mg QD. BOS, budesonide oral suspension. Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions

Figure 2 (A) Histologic and (B) endoscopic outcomes during the open-label extension (OLE) in the placebo/budesonide oral suspension (BOS) and BOS/BOS groups. Histologic response (≤1, ≤6, or ≤15 eos/hpf) after 24 weeks of open-label BOS therapy or early termination, and total Endoscopic Reference Score (EREFS) at OLE baseline and week 24 or early termination. Response rates are cumulative (eg, patients with a histologic response of ≤1 eos/hpf were also included in the other response groups). Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 1 Histologic outcomes for patients who received budesonide oral suspension (BOS) or placebo during the 12-week double-blind phase of the trial and for patients who continued on in the 24-week open-label extension (OLE). Histologic response was defined as ≤6 eosinophils per high-power field (eos/hpf) at the end of each treatment period or early termination. Patients from the 12-week, double-blind phase represent the modified intention-to-treat population. The modified intention-to-treat population comprised all randomized patients who received at least 1 dose of double-blind study drug and had both an evaluable postbaseline biopsy during the treatment period (ie, peak eosinophil count from at least 2 regions of the esophagus) and a post-baseline Dysphagia Symptom Questionnaire score. Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 2 Individual patient data for peak eosinophil counts (eos/hpf) for patients in the placebo/budesonide oral suspension (BOS) and BOS/BOS groups at open-label extension (OLE) baseline and OLE week 24 or early termination. (A) Placebo/BOS (proximal esophagus), (B) placebo/BOS (distal esophagus), (C) BOS/BOS (proximal esophagus), (D) BOS/BOS (distal esophagus). Of the 37 patients in the placebo/BOS group, 33 had a biopsy or histologic assessment at OLE week 24 or early termination (29 of 33 and 31 of 33 patients had biopsies available from the proximal or distal regions of the esophagus, respectively). Of the 45 patients in the BOS/BOS group, 39 had a biopsy/histologic assessment at OLE week 24 or early termination (all 39 patients had biopsies available from both the proximal and distal regions for assessment). Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 3 Individual patient data for total Endoscopic Reference Score (EREFS) for patients in the (A) placebo/budesonide oral suspension (BOS) and (B) BOS/BOS groups at OLE baseline and OLE week 24 or early termination. Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions

Supplementary Figure 4 PGA outcomes during the 24-week open-label extension (OLE) for placebo/budesonide oral suspension (BOS) and BOS/BOS groups Physician Global Assessment (PGA) score for the 2 study groups at OLE baseline and each of the time points. P values compare OLE baseline versus week 24 of the OLE or early termination. OLE baseline (placebo/BOS, n = 37; BOS/BOS, n = 45), week 6 (placebo/BOS, n = 35; BOS/BOS, n = 42), week 12 (placebo/BOS, n = 31; BOS/BOS, n = 40), week 18 (placebo/BOS, n = 29; BOS/BOS, n = 37), and week 24 or early termination (placebo/BOS, n = 37; BOS/BOS, n = 44). Clinical Gastroenterology and Hepatology 2019 17, 666-673.e8DOI: (10.1016/j.cgh.2018.05.051) Copyright © 2019 AGA Institute Terms and Conditions