Budesonide Course for Colitis
For ulcerative colitis, budesonide MMX 9 mg once daily for 8 weeks is the recommended course to induce remission in patients with mild to moderate disease who have inadequate response to mesalazine. 1, 2
Treatment Regimen by Colitis Type
Ulcerative Colitis
- Dose: Budesonide MMX 9 mg once daily in the morning 2
- Duration: Up to 8 weeks for induction of remission 1, 2
- Administration: Swallow whole; do not chew, crush, or break 2
- Food: Can be taken with or without food 2
Efficacy data: Combined clinical and endoscopic remission rates of 17.7% versus 6.2% for placebo, with symptom resolution rates of 28.5% versus 16.5% for placebo 3, 4
Crohn's Disease (Ileocecal/Proximal Colon)
- Dose: Ileal-release budesonide 9 mg once daily 5, 6
- Duration: 8 weeks for induction 5, 6
- Tapering: After achieving remission, taper over 1-2 weeks rather than abrupt discontinuation 5, 6, 7
Important limitation: Ileal-release budesonide has benefit in proximal colonic Crohn's disease but no evidence of benefit for distal colonic inflammation 5, 7
Monitoring Timeline
Early Assessment (2 Weeks)
- Evaluate for lack of symptomatic response to determine if therapy modification is needed 1
- If inadequate response at 2 weeks in ulcerative colitis, consider escalating to advanced therapies (biologics or small molecules) 1
Mid-Treatment Assessment (4-8 Weeks)
Critical Contraindications and Cautions
Do NOT Use for Maintenance Therapy
Budesonide should NOT be used for maintenance therapy in ulcerative colitis or Crohn's disease as it is ineffective for maintaining remission and prolonged use is associated with significant adverse effects 1, 6, 7
Disease Severity Limitations
- Budesonide is appropriate only for mild to moderate disease (CDAI <300 in Crohn's disease) 6
- In severe Crohn's disease (CDAI >300), budesonide is inferior to prednisolone (RR 0.52,95% CI 0.28 to 0.95) and systemic corticosteroids should be used instead 5, 6
Disease Location Considerations
- Ulcerative colitis: Budesonide MMX is particularly effective for left-sided disease but less effective for extensive colitis 1
- Crohn's disease: Effective for ileocecal and proximal colonic disease; no benefit for distal colonic inflammation 5, 7
Drug Interactions and Special Populations
CYP3A4 Inhibitors
- Avoid grapefruit juice during treatment 2
- If concomitant ketoconazole or other CYP3A4 inhibitors are necessary, closely monitor for hypercorticism 2
- Consider discontinuing either budesonide or the CYP3A4 inhibitor 2
Patients with Liver Disease
- Monitor patients with moderate to severe liver disease for increased signs/symptoms of hypercorticism 2
- Consider discontinuing budesonide in these patients 2
Safety Monitoring
Adrenal Suppression
- Monitor for signs and symptoms of hypercorticism and adrenal axis suppression during treatment 2
- In stress situations (surgery, trauma), supplementation with systemic glucocorticosteroid is recommended 2
Immunosuppression Risk
- Budesonide suppresses the immune system and increases risk of infection with any pathogen 2
- Use caution in patients with active or latent infections 2
Bone Health (If Prolonged Use Required)
- Although not recommended for maintenance, if prolonged use occurs, consider osteoporosis prevention and screening as budesonide may predispose to bone loss 7
Common Pitfalls to Avoid
- Using budesonide for maintenance therapy - This is ineffective and exposes patients to unnecessary risks 1, 6
- Failing to taper after remission - Abrupt discontinuation may lead to symptom recurrence; taper over 1-2 weeks 6, 7
- Using in severe disease - Budesonide is inferior to systemic steroids in severe disease 5, 6
- Extending treatment beyond 8 weeks - If inadequate response, consider alternative therapies rather than prolonging budesonide 1
- Using for distal colonic Crohn's disease - No evidence of benefit in this location 5, 7