Oral budesonide is as effective as oral prednisolone in active Crohn’s disease

• Published in: Gut Vol. 41; no. 2; pp. 209 - 214
• Main Authors: Campieri, M, Ferguson, A, Doe, W, Persson, T, Nilsson, L-G
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and British Society of Gastroenterology 01.08.1997; BMJ; BMJ Publishing Group LTD
• Subjects: adrenal function; Biological and medical sciences; Bowel disease; CDAI; Crohns disease; Digestive system; Drug dosages; glucocorticoid; glucocorticoid associated side effects; Inflammatory Bowel Disease; Medical sciences; Metabolism; Metabolites; Ostomy; Pharmacology. Drug treatments; Prescription drugs; Sweden; Antineoplastic agent; Human; Budesonide; Corticosteroid; Multicenter study; Antiinflammatory agent; Oral administration; Inflammatory disease; Crohn disease; Chemotherapy; Treatment; Efficiency; Adrenal hormone; Digestive diseases; Intestinal disease; Clinical trial; Immunosuppressive agent; Safety; Comparative study; Prednisolone
• ISSN: 0017-5749; 1468-3288; 1458-3288
• DOI: 10.1136/gut.41.2.209

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.