Volume 115, Issue 3, Pages 525-532 (September 1998) Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: A dose-ranging study  Stephen B. Hanauer, Malcolm Robinson, Ronald Pruitt, Audrey J. Lazenby, Tore Persson, Lars–Goran Nilsson, Karen Walton–Bowen, Lloyd P. Haskell, Jeffrey G. Levine  Gastroenterology  Volume 115, Issue 3, Pages 525-532 (September 1998) DOI: 10.1016/S0016-5085(98)70131-3 Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 1 Sigmoidoscopic inflammation grade. The adjusted mean changes from baseline show the improvement in inflammation grade for each treatment arm at each evaluated time point. Budesonide enema at 2.0 mg significantly improved sigmoidoscopic inflammation after 4 weeks (**P ≤ 0.010 vs. placebo) and 6 weeks (***P ≤ 0.001 vs. placebo). Budesonide enema at 8.0 mg significantly improved sigmoidoscopic inflammation after 2, 4, and 6 weeks (***P ≤ 0.001 vs. placebo). Gastroenterology 1998 115, 525-532DOI: (10.1016/S0016-5085(98)70131-3) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 2 Total histopathology score at week 6. Mean change from baseline showing the improvement in total histopathology score (the sum of the active and chronic inflammation and crypt distortion components). Budesonide enema at 2.0 and 8.0 mg significantly improved total histopathology scores after 6 weeks of treatment (*P ≤ 0.050 vs. placebo and ***P ≤ 0.001 vs. placebo, respectively). Gastroenterology 1998 115, 525-532DOI: (10.1016/S0016-5085(98)70131-3) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 3 Percent of patients in remission (primary definition). After 6 weeks of treatment, both budesonide enema at 2.0 mg and 8.0 mg induced remission in a higher percentage of patients compared with placebo (*P ≤ 0.050 and ***P ≤ 0.001, respectively). For week 6, 95% confidence intervals are shown in parentheses. Remission was defined as including all of the following during the 2 days before physician visit: three or less bowel movements per day; no blood in stool; no symptoms of urgency, abdominal pain, or painful evacuations; and sigmoidoscopic inflammation grade of 0. Gastroenterology 1998 115, 525-532DOI: (10.1016/S0016-5085(98)70131-3) Copyright © 1998 American Gastroenterological Association Terms and Conditions

Fig. 4 Total investigator assessment of ulcerative colitis symptom score. Mean change from baseline showing improvement in the sum of the ulcerative colitis symptom score (sum of diarrhea, abdominal pain, intermittent tenesmus, and rectal bleeding). Budesonide enema at 0.5 mg significantly improved ulcerative colitis symptom scores at week 2 and week 6 (*P ≤ 0.050) compared with placebo. Budesonide enema at 2.0 mg and 8.0 mg significantly improved colitis symptom scores at week 2 (**P ≤ 0.010 and ***P ≤ 0.001, respectively) and week 4 and week 6 (***P ≤ 0.001) compared with placebo. Gastroenterology 1998 115, 525-532DOI: (10.1016/S0016-5085(98)70131-3) Copyright © 1998 American Gastroenterological Association Terms and Conditions