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

• Published in: Journal of Crohn's and colitis Vol. 4; no. 6; pp. 629 - 636
• Main Authors: Nunes, Tiago, Barreiro-de Acosta, Manuel, Nos, Pilar, Marin-Jiménez, Ignacio, Bermejo, Fernando, Ceballos, Daniel, Iglesias, Eva, Gomez-Senent, Silvia, Torres, Yolanda, Ponferrada, Angel, Arevalo, José A, Hernandez, Vicent, Calvet, Xavier, Ginard, Daniel, Monfort, David, Chaparro, Maria, Manceñido, Noemi, Domínguez-Antonaya, Mercedes, Villalón, César, Perez-Calle, José L, Muñoz, Carmen, Nuñez, Henar, Carpio, Daniel, Aramendiz, Roberto, Bujanda, Luis, Estrada-Oncins, Silvia, Hermida, Carlos, Barrio, Jesus, Casis, M Begoña, Dueñas-Sadornil, M Carmen, Fernández, Luis, Calvo-Cenizo, M Mar, Botella, Belen, de Francisco, Ruth, Ayala, Edgar, Sans, Miquel
• Format: Journal Article
• Language: English
• Published: England 01-12-2010
• Subjects: Administration, Oral; Adult; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - therapeutic use; Beclomethasone - administration & dosage; Beclomethasone - therapeutic use; Colitis, Ulcerative - drug therapy; Drug Administration Schedule; Female; Humans; Male; Remission Induction; Retrospective Studies; Severity of Illness Index; Treatment Outcome
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1016/j.crohns.2010.07.003

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.
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.
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.
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.