Oral budesonide is as effective as oral prednisolone in activeCrohn's disease

Background—The use of corticosteroids in activeCrohn's disease often becomes limited by side effects. Budesonide is apotent corticosteroid with low systemic bioavailability due to anextensive first pass liver metabolism.
Aims—To compare the efficacy and safety of twodosage regimens of budesonide and prednisolone in patients with activeCrohn's disease affecting the ileum and/or the ascending colon.
Patients and methods—One hundred and seventy eightpatients 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'sDisease Activity Index (CDAI) of 150 or less.
Results—After eight weeks of treatment, remissionoccurred in 60% of patients receiving budesonide once daily orprednisolone and in 42% of those receiving budesonide twice daily(p=0.062). The presence of glucocorticoid associated side effects wassimilar in all groups; however, moon face was more common in theprednisolone group (p=0.0005). The highest frequency of impairedadrenal function, as measured by a short ACTH test, was found in theprednisolone group (p=0.0023).
Conclusions—Budesonide CIR, administered at 9 mgonce daily or 4.5 mg twice daily, is comparable to prednisolone ininducing remission in active Crohn's disease. The single doseadministration is as promptly effective as prednisolone and representsa simpler and safer therapeutic approach, with a considerable reduction in side effects.

Keywords:adrenal function; CDAI; glucocorticoid; glucocorticoid associated side effects