Budesonide (Uceris) has been formulated with the MMX delivery technology and now has been FDA approved for mild to moderate ulcerative colitis in adults. The potential advantage of budesonide compared with conventional corticosteroids is for targeting anti-inflammatory activity to the colon with less systemic side effects. The potential downside includes the high cost. According to one website (see below), the average wholesale cost is just below $1500 per month. In addition, only a minority of individuals responded to budesonide in published studies:
Induction of Remission in Studies 1 and 2 (reference below)
|
Treatment Group |
Study 1 n/N (%) |
Study 2 n/N (%) |
|
UCERIS 9 mg |
22/123 (17.9) |
19/109 (17.4) |
|
UCERIS 6 mg |
16/121 (13.2) |
9/109 (8.3) |
|
Reference Arm* |
15/124 (12.1) |
13/103 (12.6) |
|
Placebo |
9/121 (7.4) |
4/89 (4.5) |
|
Treatment Difference between UCERIS 9 mg and Placebo (95% CI)† |
10.4% (2.2%, 18.7%) |
12.9% (4.6%, 21.3%) |
- Table from Confidential Page 1 of 16 Reference ID: 3244996 – Accessdata FDA …
- FDA Approves Uceris for Ulcerative Colitis
- Treatment for Ulcerative Colitis Flare Up | UCERIS (budesonide …
- Information for Vermont Prescribers of Prescription Drugs: UCERIS …
Data for budesonide for pediatric patients with ulcerative colitis is not available.
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