What is the standard baseline dose of Entocort (budesonide) for an adult with mild Crohn’s disease limited to the terminal ileum?

Baseline Entocort Dose for Mild Terminal Ileal Crohn's Disease

For an adult with mild Crohn's disease limited to the terminal ileum, the standard baseline dose of Entocort (budesonide) is 9 mg once daily for 8 weeks. 1, 2, 3

Dosing Regimen

• The recommended dose is 9 mg once daily, which can be taken as a single morning dose rather than divided throughout the day 4
• Treatment duration should be 8 weeks to induce remission 1, 3
• After achieving remission, taper the dose over 1-2 weeks rather than abruptly discontinuing to prevent symptom recurrence 2, 3

Evidence Supporting This Dose

The 9 mg daily dose is strongly supported by multiple high-quality guidelines:

• The European Crohn's and Colitis Organisation (ECCO) strongly recommends budesonide 9 mg/day for mild-to-moderate Crohn's disease limited to the ileum and/or ascending colon, based on moderate-quality evidence 1
• The American Gastroenterological Association recommends budesonide 9 mg/day as first-line therapy for mild to moderate ileocecal Crohn's disease 2
• Clinical trials demonstrate that 9 mg daily achieves remission in approximately 51% of patients compared to only 20% with placebo 3, 5

Once Daily vs. Divided Dosing

• The full 9 mg dose can be given once daily in the morning without compromising efficacy 4
• A randomized trial comparing 9 mg once daily versus 3 mg three times daily showed non-inferior efficacy (71.3% vs 75.1% remission rates) with similar safety profiles 4
• Once-daily dosing may improve adherence and is therefore preferred in clinical practice 4

Disease Severity Considerations

This 9 mg dose is appropriate only for mild to moderate disease (CDAI <300):

• For severe disease (CDAI >300), systemic corticosteroids like prednisolone should be used instead of budesonide 3
• Budesonide is effective specifically for ileocecal and proximal colonic disease but has no proven benefit for distal colonic inflammation 3

Monitoring and Follow-Up

• Evaluate for symptomatic response between 4-8 weeks to determine if therapy modification is needed 2, 3
• If there is inadequate response by 2 weeks, consider escalating therapy rather than continuing budesonide 2

Critical Pitfall to Avoid

Do not use budesonide for maintenance therapy after achieving remission:

• Budesonide is ineffective for maintaining remission in Crohn's disease 2, 3
• Prolonged use beyond the 8-week induction period is associated with significant adverse effects including adrenal suppression and bone loss 2, 3
• After the 8-week course and 1-2 week taper, transition to appropriate maintenance therapy (such as immunomodulators or biologics) rather than continuing budesonide 3

Safety Profile

• Budesonide has significantly fewer glucocorticoid-related adverse effects compared to prednisolone due to its high first-pass hepatic metabolism and low systemic bioavailability (approximately 11%) 3, 6
• The incidence of adverse events with budesonide 9 mg/day is similar to placebo and significantly lower than conventional corticosteroids 1, 6