Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU Study.

Abstract

BACKGROUND:

Beclometasone dipropionate (BDP) is a relatively new topically acting oral steroid to treat mild to moderately active ulcerative colitis (UC). We estimate that 20,000 patients have received oral BDP in Spain in the last two years. Our aim was to evaluate the efficacy and safety of oral BDP in clinical practice.

METHODS:

Retrospective and multicenter study that included 434 patients with active UC treated with BDP. The partial Mayo Clinic score (pMS, 0-9) was used to measure disease activity. Remission was defined as post-treatment pMS of 0 or 1; response as a decrease in pMS of 3 points or 2 points and >30%, and failure as lack of remission or response.

RESULTS:

BDP dose was 5 mg/day in 88% of patients and mean treatment duration was 6.2 weeks. BDP achieved remission in 44.4%, response in 22.3% and failed in 33.2% of patients. Mean pMS decreased from 4.9 ± 1.3 to 2.4 ± 2.3 (p<0.0001). Remission rate was higher in mild and moderate than in severe UC (p<0.043) and tended to be higher in left-sided and extensive UC than in proctitis (p<0.06). Failure was less frequent in patients treated for >4 weeks (p<0.02). Mild adverse events were reported in 7.6% of patients.

CONCLUSION:

BDP induces response or remission in two thirds of active UC patients, with a good safety profile. Patients with mild to moderate, left-sided or extensive UC, receiving BDP for more than 4 weeks are most likely to benefit from this treatment.

• Authors: Tiago Nunes, Manuel Barreiro-de Acosta, Pilar Nos, Ignacio Marin-Jiménez, Fernando Bermejo, Daniel Ceballos, Eva Iglesias, Silvia Gomez-Senent, Yolanda Torres, Angel Ponferrada, José A Arevalo, Vicent Hernandez, Xavier Calvet, Daniel Ginard, David Monfort, Maria Chaparro, Noemi Manceñido, Mercedes Domínguez-Antonaya, César Villalón, José L Perez-Calle, Carmen Muñoz, Henar Nuñez, Daniel Carpio, Roberto Aramendiz, Luis Bujanda, Silvia Estrada-Oncins, Carlos Hermida, Jesus Barrio, M Begoña Casis, M Carmen Dueñas-Sadornil, Luis Fernández, M Mar Calvo-Cenizo, Belen Botella, Ruth de Francisco, Edgar Ayala, Miquel Sans, RECLICU Study Group of GETECCU
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 4 Issue 6 Pg. 629-36 (Dec 2010) ISSN: 1876-4479 [Electronic] England
• PMID: 21122572 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.

Chemical References

• Anti-Inflammatory Agents
• Beclomethasone

Topics

• Administration, Oral
• Adult
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Beclomethasone (administration & dosage, therapeutic use)
• Colitis, Ulcerative (drug therapy)
• Drug Administration Schedule
• Female
• Humans
• Male
• Remission Induction
• Retrospective Studies
• Severity of Illness Index
• Treatment Outcome