Background: It may be possible to achieve more effective management of Croh
n's Disease by introducing a flexible dosage regimen sensitive to patients'
Aim: Comparison of the efficacy and tolerability of a fixed vs. flexible bu
desonide controlled ileal release treatment regimen for the prevention and
management of relapse in Crohn's disease patients. Budesonide controlled il
eal release is an oral formulation which delivers drug directly to disease
sites in the ileum and ascending colon, by preventing more proximal release
Methods: A randomized, double-blind comparison of a fixed dose of budesonid
e controlled ileal release (6 mg o.m.) and a flexible dose of budesonide co
ntrolled ileal release (3, 6 or 9 mg o.m.) for 12 months, in 143 patients i
n remission from ileal or ileo-caecal Crohn's Disease.
Results: Very low rates of clinical relapse in Crohn's disease were achieve
d with budesonide controlled ileal release 6 mg o.m. There was no significa
nt difference between the treatment groups with respect to the survival est
imate of percentage of treatment failures (flexible group 15%, fixed group
19%; P = 0.61). The average consumed dose of budesonide was comparable in b
oth 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 significan
t 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 re
lapse 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.