The effects of azathioprine and budesonide on mucosal healing and histologic remission of Crohn's disease are insufficiently studied.
Dr Gerassimos Mantzaris and colleagues from Greece evaluated the comparative effects of azathioprine and budesonide on endoscopic and histologic activity.
The researchers evaluated patients with steroid-dependent Crohn's ileocolitis or proximal colitis who had achieved clinical remission on conventional steroids.
The team randomized 38 patients to azathioprine (2.0-2.5 mg/kg a day) or 39 budesonide (6-9 mg a day) for 1 year.
The study protocol included clinical examination, laboratory tests, and calculation of the Crohn's Disease Activity Index.
|Complete healing was achieved in 83% of azathioprine-treated patients |
|Inflammatory Bowel Diseases |
In addition, the team obtained data from completion of the Inflammatory Bowel Disease Questionnaire, at baseline and then every 2 months for 1 year.
Ileocolonoscopy with regional biopsies was performed at baseline, and then at the end of the study to assess mucosal healing and the histologic activity of Crohn's disease.
At the end of the study, 32 and 25 patients in the azathioprine and budesonide groups, respectively, were in clinical remission.
The Crohn's Disease Endoscopic Index of Severity score fell significantly only in the azathioprine group.
Complete or near complete healing was achieved in 83% of azathioprine-treated patients compared with only 24% of budesonide-treated patients.
Histologic activity as assessed by an average histology score fell significantly only in the azathioprine group.
The research team noted that histological activity was significantly lower than in the budesonide group at the end of the study.
The researchers reported that 8 patients in the azathioprine group were withdrawn for adverse events or relapse of disease vs 14 patients in the budesonide group.
Dr Mantzaris’ team concluded, “In patients with steroid-dependent inflammatory Crohn's ileocolitis or proximal colitis who achieve clinical remission with conventional steroids.”
“A 1-year treatment with azathioprine was superior to budesonide in achieving and maintaining mucosal healing and histologic remission.”