Astra Files For Entocort Capsules In UK

Astra Pharmaceuticals has submitted a license application in the UK for use of its controlled-release Entocort (budesonide) capsules for the treatment of Crohn's disease. Providing support for the submission, Paul Rutgeerts, professor of gastroenterology at Leuven University Hospital, Belgium, presented data at an Astra meeting in Amsterdam last month from a European multicenter trial of budesonide versus prednisolone in 176 patients with active Crohn's disease.

The 88 patients in each arm of the study were well matched, reported Dr Rutgeerts. A total of 31 patients withdrew from the trial (16 in the budesonide group and 15 in the prednisolone group) mostly as a result of therapeutic failure. After two weeks, 39 patients (45%) in the budesonide arm and 48 patients (56%) in the prednisolone-treated group were in clinical remission. The respective figures were 40% and 67% at four weeks, 52% and 65% at eight weeks and 53% and 66% at 10 weeks.

Scores on the Crohn's disease activity index decreased in both groups after two weeks' therapy. The mean decrease at this time in the budesonide patients was 101 points, compared to 130 points for the prednisolone group. Patients in the prednisolone group had the greater decrease in the number of liquid or soft stools and a greater increase in body weight and general wellbeing at most time points. However, (and this is the main advantage of budesonide over prednisolone), 29 budesonide patients and 48 prednisolone patients had one or more side effects associated with therapy. In addition, the mean plasma cortisol concentrations were significantly greater in the prednisolone group after two, four and eight weeks.