Budesonide exhibits anti-diarrheal activity independent of its anti-inflammatory effects.1 The number of bowel movements per day has a great influence on the general well-being and quality of life of patients (also in Crohn’s Disease (CD)). In post-hoc analyses of a Phase III study in CD,2 the early anti-diarrheal effect of Budesonide (ENTOCORTTM)(ENT) was evaluated.Methods
Number of liquid or very soft stools (NSt) and abdominal pain rating (AP) are subscores of the Crohn’s Disease Activity Index (CDAI) score. In a Japanese multi-centre, double-blind, randomised pivotal study in patients with active CD safety and efficacy of ENT (9 mg/d; n=53) and Mesalazine (MZ) (3 g/d; n=53) were assessed, investigating CDAI score and Inflammatory Bowel Disease Questionnaire (IBDQ) at screening and 2, 4 and 8 weeks after treatment start (among other endpoints). Change of NSt, AP and IBDQ at week 2 to pre-dose were compared between the treatments in retrospective analyses of the dataset applying ANCOVA using baseline as covariate.Results
The number of liquid and very soft stools in ENT treated patients significantly decreased within 2 weeks treatment compared to MZ (−7.1±12.3 (ENT) vs. −2.5±6.8 (MZ), mean ±SD, p=0.02) whereas there was no significant effect on abdominal pain, respectively (−1.8±4.3 vs. −1.2±3.7, p=0.25). In parallel, total IBDQ (17.3±19.7 (ENT) vs. 7.4±17.2 (MZ), p=0.01) and subscore in emotional function (5.6±8.4 vs. 2.0±7.2, p=0.02) significantly improved more in the ENT treated patients compared to MZ.Conclusions
Budesonide (ENTOCORTTM) reduced the frequency of liquid and very soft stools significantly better than Mesalazine within 2 weeks of treatment. This reduction of diarrheal symptom resulted in a quicker improvement of Quality of Life in CD patients treated with Budesonide (ENTOCORTTM) as compared with Mesalazine.