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


CONCLUSIONS
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.
Hospital Clínic i Provincial/IDIBAPS, Barcelona, Spain.
Tiago
T
Nunes
Manuel
M
Barreiro-de Acosta
Pilar
P
Nos
Ignacio
I
Marin-Jiménez
Fernando
F
Bermejo
Daniel
D
Ceballos
Eva
E
Iglesias
Silvia
S
Gomez-Senent
Yolanda
Y
Torres
Angel
A
Ponferrada
José A
JA
Arevalo
Vicent
V
Hernandez
Xavier
X
Calvet
Daniel
D
Ginard
David
D
Monfort
Maria
M
Chaparro
Noemi
N
Manceñido
Mercedes
M
Domínguez-Antonaya
César
C
Villalón
José L
JL
Perez-Calle
Carmen
C
Muñoz
Henar
H
Nuñez
Daniel
D
Carpio
Roberto
R
Aramendiz
Luis
L
Bujanda
Silvia
S
Estrada-Oncins
Carlos
C
Hermida
Jesus
J
Barrio
M Begoña
MB
Casis
M Carmen
MC
Dueñas-Sadornil
Luis
L
Fernández
M Mar
MM
Calvo-Cenizo
Belen
B
Botella
Ruth
R
de Francisco
Edgar
E
Ayala
Miquel
M
Sans
D000284:Administration, Oral; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D001507:Beclomethasone