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).
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.
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.
BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups.
1Department of Gastroenterology, UZ Gasthuisberg, Leuven, Belgium
2Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy
3Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy
4Hospital Galdakao, Barrio Labeaga, Vizcaya, Spain
5Policlinica Algomed, Centru Medical e Gastroenterologie, Medicina Interna si Nefrologie, Timisoara, Romania
6St Petersburg State Medical Academy n.a. I.I. Mechnikov, St Petersburg, Russia
7Endoskopia B. Chrobrego 6/8 81-756, Sopot, Poland
8Department of Gastroenterology, University Hospital Careggi, Florence, Italy
9Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium
Correspondence: Gert Van Assche, MD, PhD, Department of Gastroenterology, UZ Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. E-mail: Gert.Vanassche@uz.kuleuven.ac.be
Received 09 October 2014; accepted 17 March 2015
Guarantor of the article: Gert Van Assche, MD, PhD.
Specific author contributions: Each author listed in this manuscript contributed to this research project. Gert Van Assche and Antonio Balzano were the coordinating investigators of the study. Gert Van Assche, Francesco Manguso, Vito Annese, Marco Zibellini, and Guido Varoli prepared the manuscript and had full access to all of the data and take responsibility for the integrity of the data and accuracy of the data analysis. José Luis Cabriada Nuño, Adrian Goldis, Evgeniy Tkachenko, Dariusz Kleczkowski, and François D'Heygere were the principal investigators of the best recruiting study centers. Marco Zibellini and Gert Van Assche are representatives of Chiesi Farmaceutici S.p.A. (sponsor), Parma, Italy, and helped in the planning and organization of the study.
Financial support: Chiesi Farmaceutici S.p.A. was the sponsor of the study and financed the conduction of it. CROMSOURCE S.r.l., via Scuderlando 10, 37135 Verona (Italy), and PhideaMarvin, via Cristoforo Colombo, 1, 20094 Corsico, Milan, Italy, were the contract research organizations in charge of the periodic monitoring of the investigational sites as well as CROS NT S.r.l., via Germania 2, 37135, was in charge of the statistical analysis and data management.
Potential competing interests: Gert Van Assche received a speakers’ fee paid to the University of Leuven by Chiesi Farmaceutici S.p.A. All authors received clinical research funds from Chiesi Farmaceutici S.p.A. as site investigators for this study. Marco Zibellini and Guido Varoli are full employees of Chiesi Farmaceutici S.p.A., sponsor of the study.