Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group

Abstract

Background: The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism.

Aims: To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon.

Patients and methods: One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks. The primary efficacy variable was clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of 150 or less.

Results: After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p = 0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p = 0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p = 0.0023).

Conclusions: Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn's disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.

Figure 1

: Mean (SE) proportion of patients in remission after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone.

Figure 2

: Mean (SE) CDAI score at randomisation and after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone.

Figure 3

: Mean (SE) morning plasma cortisol at randomisation and after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone.