Budesonide is a corticosteroid that has low systemic bioavailability due to high first-pass metabolism in the liver. It is effective for inducing remission in mild ileal and ileocaecal Crohn’s disease.
Benefit & risk (Crohn's disease)
Response and remission
- After 8 weeks of treatment, budesonide is significantly more effective than placebo (RR 1.96, 95% CI 1.19 to 3.23) or mesalamine (RR 1.63; 95%CI 1.23 to 2.16) to induce remission.
- Although it is less effective than prednisolone (RR 0.86) its better safety profile makes it use preferable
Maintenance of remission
- Budesonide may delay relapse after medically induced remission, but is not effective at maintaining remission by 12 months.
Prevention of relapse post surgery
- There is no evidence to support a role in preventing post-operative relapse.
Major side effects
- Fewer side effects than prednisolone (RR 0.64, occur in 33% and of less severe nature cf. 55% taking prednisolone).
- National Formularly should be consulted to review adverse drug reactions and drug interactions.
Dose and administration
- 9mg PO od (e.g. 9mg PO od for two months then 3 mg PO od for one month)
- Consider adjunct vitamin D / Ca++.
Pregnancy and lactation
- It is not known whether budesonide is safe in pregnancy
- Toxic doses in animal studies are teratogenic therefore it should be avoided.