Comparison 1. Budesonide MMX® 9 mg versus placebo.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission (combined clinical and endoscopic remission)	3	900	Risk Ratio (M‐H, Fixed, 95% CI)	2.25 [1.50, 3.39]
2 Remission (combined clinical and endoscopic remission): subgroup by mesalamine use	3	900	Risk Ratio (M‐H, Fixed, 95% CI)	2.25 [1.50, 3.39]
2.1 Concurrent mesalamine	1	458	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.99, 3.08]
2.2 No mesalamine	2	442	Risk Ratio (M‐H, Fixed, 95% CI)	2.89 [1.59, 5.25]
3 Remission (combined clinical and endoscopic remission) subgroup by disease location	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.1 Combined proctosigmoiditis and left‐sided disease	2	289	Risk Ratio (M‐H, Fixed, 95% CI)	2.98 [1.56, 5.67]
3.2 Extensive disease	2	145	Risk Ratio (M‐H, Fixed, 95% CI)	2.41 [0.61, 9.56]
4 Clinical Improvement (without remission) at 4 weeks	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
5 Clinical remission or reduction in CAI of at least 50% at 4 weeks	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
6 No change or worsening of disease at 4 weeks	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
7 Endoscopic Improvement at 4 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
8 Histologic Improvement at 4 weeks	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected
9 Morning Cortisol Suppression at 4 weeks	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
10 Clinical improvement	2	442	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.99, 1.70]
11 Symptom resolution	2	442	Risk Ratio (M‐H, Fixed, 95% CI)	1.86 [1.25, 2.77]
12 Endoscopic improvement	2	442	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [1.01, 1.66]
13 Histologic remission	3	900	Risk Ratio (M‐H, Fixed, 95% CI)	1.51 [1.11, 2.06]
14 Histologic remission: sensitivity analysis	2	442	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.75, 2.75]
15 Endoscopic remission	2	695	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [1.13, 2.16]
16 Endoscopic remission: sensitivity analysis	1	237	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [0.91, 2.40]
17 Endoscopic remission according to disease location	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
17.1 Proctosigmoiditis	1	75	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [0.75, 3.65]
17.2 Left‐sided disease	1	66	Risk Ratio (M‐H, Fixed, 95% CI)	1.53 [0.76, 3.09]
17.3 Extensive disease	1	105	Risk Ratio (M‐H, Fixed, 95% CI)	1.97 [0.65, 6.00]
18 Adverse events	3	971	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.95, 1.26]
19 Serious adverse events	2	513	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.33, 2.40]
20 Treatment‐related serious adverse events	2	513	Risk Ratio (M‐H, Fixed, 95% CI)	3.04 [0.32, 28.99]
21 Potential glucocorticoid effects	2	513	Risk Ratio (M‐H, Fixed, 95% CI)	0.90 [0.53, 1.53]
22 Withdrawal due to adverse events	3	971	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.68, 1.43]