Maintenance of Crohn’s disease over 12 months: fixed versus flexible dosing regimen using budesonide controlled ileal release capsules

Abstract

Background: It may be possible to achieve more effective management of Crohn’s Disease by introducing a flexible dosage regimen sensitive to patients’ needs. Aim: Comparison of the efficacy and tolerability of a fixed vs. flexible budesonide controlled ileal release treatment regimen for the prevention and management of relapse in Crohn’s disease patients. Budesonide controlled ileal release is an oral formulation which delivers drug directly to disease sites in the ileum and ascending colon, by preventing more proximal release and absorption. Methods: A randomized, double‐blind comparison of a fixed dose of budesonide controlled ileal release (6 mg o.m.) and a flexible dose of budesonide controlled ileal release (3, 6 or 9 mg o.m.) for 12 months, in 143 patients in remission from ileal or ileo–caecal Crohn’s Disease. Results: Very low rates of clinical relapse in Crohn’s disease were achieved with budesonide controlled ileal release 6 mg o.m. There was no significant difference between the treatment groups with respect to the survival estimate of percentage of treatment failures (flexible group 15%, fixed group 19%; P=0.61). The average consumed dose of budesonide was comparable in both groups (5.8 mg flexible, 6.0 mg fixed). Similar proportions of patients reported adverse events (flexible 100%, fixed 97%). There were 33 serious adverse events (flexible 19, fixed 14) and 13 withdrawals due to significant adverse events (flexible 9, fixed 4). Conclusion: Maintenance treatment with budesonide controlled ileal release 6 mg o.m. is well‐tolerated and is associated with low rates of clinical relapse in stable Crohn’s disease over 12 months. Flexible dosing remains an option for individual patients, but this study has shown no advantage over a standard fixed dosing regimen.

European evidence based consensus on the diagnosis and management of Crohn's disease: current management

“…As these are meta-analyses, an additional trial has compared administration of a fixed dose of budesonide (6 mg daily) with a flexible dose (3-9 mg) for 12 months in 143 patients with inactive ileocaecal CD. 129 No significant difference was found. The average amount of budesonide received by the patients was comparable in the two groups.…”

Budesonide for Maintenance of Remission in Patients with Crohn's Disease in Medically Induced Remission: A Predetermined Pooled Analysis of Four Randomized, Double-Blind, Placebo-Controlled Trials

“…Oral budesonide capsules 6 mg/day are more effective than placebo or mesalamine 3 g/day for maintenance of remission in patients with steroid-dependent CD (24,25); and oral pH-modified release budesonide 6-18 mg/day is effective for the short-term maintenance of remission in patients with prednisolone-induced remission (26). Maintenance therapy with a variable dose of oral budesonide capsules at a dose of 0-9 mg/day to maintain symptomatic remission results in similar control of disease activity as oral budesonide capsules at a fixed dose of 6 mg/day (27) or prednisolone 0-40 mg/day adjusted to disease activity (28). Maintenance therapy with oral budesonide capsules 6-9 mg/day resulted in a similar clinical remission rate at 1 yr as azathioprine 2.2 mg/kg/day, but azathioprine resulted in greater endoscopic remission (29).…”

Budesonide: Teaching an Old Dog New Tricks for Inflammatory Bowel Disease Treatment

“…At the end of the study a decrease in steroid-related side effects together with recovery of adrenal function (which was impaired at baseline) were found in both the placebo and budesonide groups [42]. In a further study of 143 patients with CD in remission, a very low rate of relapse was found with administration of 6 mg/day budesonide maintenance treatment [43].…”