Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled Trial

Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk...

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Detalles Bibliográficos
Autores: Ginard, Daniel, Barreiro-de Acosta, Manuel, Nos, Pilar, Moraleja, Irene, Muñoz Nuñez, Fernando, Aldeguer, Xavier, Echarri, Ana, Villoria, Albert, Riestra, Sabino, Boscá-Watts, Marta Maia, González-Lama, Yago, Royo Escosa, Vanesa, Ferreiro-Iglesias, Rocío, Iborra, Marisa, Elorza, Ainara, Fernandez-Pordomingo, Alejandra, Sans, Miquel
Tipo de recurso: artículo
Fecha de publicación:2024
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/21187
Acceso en línea:https://hdl.handle.net/20.500.13003/21187
Access Level:acceso abierto
Palabra clave:Adult
Anti-Inflammatory Agents / therapeutic use
Beclomethasone* / administration & dosage
Beclomethasone* / therapeutic use
Colitis, Ulcerative* / drug therapy
Colitis, Ulcerative* / metabolism
Double-Blind Method
Feces* / chemistry
Female
Humans
Leukocyte L1 Antigen Complex* / analysis
Leukocyte L1 Antigen Complex* / metabolism
Male
Middle Aged
Recurrence
Remission Induction
Treatment Outcome
Young Adult
Adulto
Método Doble Ciego
Femenino
Humanos
Masculino
Persona de Mediana Edad
Recurrencia
Inducción de Remisión
Resultado del Tratamiento
Adulto Joven
Descripción
Sumario:Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse. This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission treated with 5-aminosalicylic acid and with FC levels ≥250 μg/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC ≥100 μg/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9. Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 μg/g (p value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p value = 0.049). Both treatment groups showed a favorable safety profile, with the most common adverse events being gastrointestinal disorders. In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated.

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