COPENHAGEN — Treatment of mild to moderate, distal ulcerative colitis with topical beclomethasone was about as effective and safe as use of topical mesalazine in a pilot study with 99 patients.
The results suggest that if a patient does not tolerate or respond to topical mesalazine, administered as an enema or as foam, topical beclomethasone may be an option, Livia Biancone, M.D., said at the 13th United European Gastroenterology Week.
But the results are not definitive because the study was small and was done on an open-label basis. Before beclomethasone becomes an alternative to mesalazine, the findings must be confirmed in a larger randomized controlled trial, said Dr. Biancone, a professor of medicine at the University of Rome.
The study was done at 15 centers in Italy. The patients were treated with one of the two study drugs in either an enema or foam formulation once daily, at night, for 8 weeks, meaning they were split into four different treatment groups of 24–26 patients each.
Patients received a daily dose of either 3 mg beclomethasone or 2 mg mesalazine. Beclomethasone is a steroid with high local activity when used topically, but with low systemic activity.
After 4 weeks of treatment, almost 80% of the patients had a partial or complete remission. After 8 weeks, 84% of patients treated with beclomethasone had responded, as had 90% of those treated with mesalazine. About half the patients in each group had a complete remission at 8 weeks.
Disease activity index scores also fell in both groups, from an average score of about 6 at baseline to an average of about 2 after 8 weeks of treatment.
The rates of adverse events associated with the two drugs were also similar. Adverse events occurred in 33% of the beclomethasone patients and in 21% of those on mesalazine. Three patients on each drug withdrew because of an adverse event. No patient treated with beclomethasone showed changes in cortisol levels during or after treatment.