Author:

Keywords:

Science & Technology, Life Sciences & Biomedicine, Gastroenterology & Hepatology, UNDERESTIMATES CORTISOL SUPPRESSION, EVIDENCE-BASED CONSENSUS, BECLOMETASONE DIPROPIONATE, 5-AMINOSALICYLIC ACID, CURRENT MANAGEMENT, CROHNS-DISEASE, BUDESONIDE, METABOLISM, THERAPY, Administration, Oral, Adolescent, Adult, Aged, Anti-Inflammatory Agents, Beclomethasone, Colitis, Ulcerative, Double-Blind Method, Drug Administration Schedule, Female, Humans, Hydrocortisone, Intention to Treat Analysis, Male, Middle Aged, Prednisone, Severity of Illness Index, Tablets, Enteric-Coated, Young Adult, BETA study participating centers, 1103 Clinical Sciences, 3202 Clinical sciences

Abstract:

OBJECTIVES: Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC). METHODS: Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4. RESULTS: DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: -1.56; 95% confidence interval (CI) -13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups. CONCLUSIONS: BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.