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Beclomethasone Dipropionate Noninferior to Prednisone for Active Ulcerative Colitis
Safety and efficacy data from a recent study demonstrated noninferiority of oral prolonged release beclomethasone dipropionate compared with systemic prednisone for the treatment of active mild-to-moderate ulcerative colitis.
To compare safety and efficacy of prolonged release beclomethasone dipropionate (BDP; Clipper tablets, Chiesi Pharmaceuticals) vs. systemic prednisone in patients with active UC not responsive to 5-aminosalicyilic acids, researchers performed a double-blind, randomized, controlled, parallel group study (BETA study) at 39 European centers from September 2007 to December 2008.
They randomly assigned 282 patients to receive 5 mg BDP once daily for 4 weeks followed by 5 mg BDP every other day for 4 weeks alternated with matched placebo; or 40 mg prednisone once daily for 2 weeks then tapered to 30 mg, 20 mg and then 10 mg once daily for 2 weeks each. The primary efficacy endpoint was noninferiority of BDP vs. prednisone based on Disease Activity Index (DAI), and the primary safety endpoint was the proportion of patients with steroid-related adverse events and cortisol levels less than 150 nmol/l, both of which were assessed after 4 weeks.
After 4 weeks of treatment, DAI response rates were 64.6% of the BDP group compared with 66.2% of the predisone group; the primary efficacy endpoint was therefore achieved (difference between groups: – 1.56; 95% CI, – 13-9.88). In the BDP group 38.7% had steroid-related adverse events and cortisol levels less than 150 nmol/l at week 4 compared with 46.9% of the prednisone group (P = .17).
“No safety signals in both groups were detected concerning vital signs and hematochemical parameters,” the researchers wrote. “In conclusion, this first study comparing oral controlled-release BDP vs. systemic [prednisone] in active UC confirms the efficacy of both the treatment strategies for the induction of clinical and endoscopic improvement, with a positive safety profile if [prednisone] is early tapered.” – by Adam Leitenberger
Disclosure: Van Assche reports he received a speakers’ fee paid to the University of Leuven by Chiesi Pharmaceuticals. Please see the study for a full list of all other authors’ relevant financial disclosures.