What is the recommended treatment for mild to moderate active colitis using oral budesonide?

Oral Budesonide for Colitis Treatment

For mild to moderate ulcerative colitis, budesonide MMX 9 mg once daily for up to 8 weeks is recommended as an alternative first-line therapy, particularly for left-sided disease when 5-ASA therapy is inadequate. 1, 2

Treatment Recommendations Based on Disease Type and Location

Ulcerative Colitis

• First-line therapy for mild to moderate UC should be a combination of topical mesalazine 1 g/day with oral mesalazine ≥2.4 g/day 3, 4
• If inadequate response to mesalazine therapy after 10-14 days, budesonide MMX 9 mg daily can be used as an alternative to conventional steroids 5, 1
• Budesonide MMX is particularly effective for left-sided disease but less effective for extensive colitis 5
• The recommended dosage is 9 mg taken orally once daily in the morning with or without food for up to 8 weeks 2
• Tablets should be swallowed whole and not chewed, crushed, or broken 2

Crohn's Disease

• For mild to moderate ileocecal Crohn's disease, oral budesonide 9 mg/day is recommended as first-line therapy 5
• Non-MMX budesonide does not appear to be effective in the treatment of UC 5

Efficacy and Evidence

• Budesonide MMX 9 mg/day has shown 8-week combined clinical and endoscopic remission rates of 20.3% vs 3.2% for placebo 5
• Endoscopic healing rates were 27.6% vs 17.1% for budesonide MMX and placebo, respectively 5
• In the CORE I trial, budesonide MMX showed similar efficacy to oral mesalamine 2.4 g/day 6
• Subgroup analysis demonstrated that the benefit of budesonide MMX is confined primarily to left-sided disease 5, 7
• A randomized trial showed budesonide MMX 9 mg/day induced clinical, endoscopic, and histological remission more frequently than placebo in patients inadequately controlled with oral 5-ASA 5

Monitoring Response

• Patients should be evaluated for symptomatic response to budesonide between 4 and 8 weeks to determine the need to modify therapy 5, 1
• If a patient shows inadequate response, alternative therapies should be considered rather than extending treatment beyond 8 weeks 1

Important Considerations and Cautions

• Budesonide should not be used for maintenance therapy as it is ineffective for this indication and prolonged use is associated with significant adverse effects 5, 1
• Patients with moderate to severe liver disease should be monitored for increased signs of hypercorticism 2
• Avoid grapefruit juice and other CYP3A4 inhibitors when taking budesonide 2
• Unlike conventional steroids, budesonide has minimal systemic effects due to extensive first-pass hepatic metabolism 8, 7
• Common adverse events include headache, nausea, abdominal pain, and flatulence, but these occur at rates similar to placebo 7
• Morning cortisol values generally remain within normal range with budesonide MMX, unlike with conventional steroids 7, 9

Treatment Algorithm

1. Start with combination of topical and oral mesalazine for mild to moderate UC 3, 4
2. If inadequate response after 10-14 days or symptoms worsen, consider budesonide MMX 9 mg daily (particularly for left-sided disease) 5, 1
3. Continue budesonide MMX for up to 8 weeks 2
4. If no response to budesonide MMX, escalate to conventional systemic steroids 5, 4
5. Do not use budesonide for maintenance therapy after remission is achieved 5, 1