Oral beclomethasone dipropionate as an alternative to systemic steroids in mild to moderate ulcerative colitis not responding to aminosalicylates.
BACKGROUND
Aminosalicylates (5-ASA) are first-line treatment for mild-moderate ulcerative colitis (UC). Systemic corticosteroids (CS) are considered for patients in whom 5-ASA has been unsuccessful, but their use is limited by adverse effects. Beclomethasone dipropionate (BDP), a topically acting steroid with low systemic bioavailability, has a more favorable safety profile, but its role in clinical practice is not yet well established.


OBJECTIVE
The aim of the present study is to assess whether oral BDP can be an alternative treatment to systemic CS for patients with mild-moderate UC not responding to first-line therapy with 5-ASA.


METHODS
From 2003 to 2006, all consecutive patients with mild-moderate UC unresponsive to oral and topical 5-ASA (+/-topical CS) administered for at least 3 weeks received an 8-week course of oral BDP (10 mg/day for 4 weeks and 5 mg/day for an additional 4 weeks). Co-primary end-points were: (1) clinical remission within 8 weeks, without need of systemic CS; (2) steroid-free remission for 12 months.


RESULTS
Sixty-four patients were included. In this study, within 8 weeks, 48/64 patients (75%) entered remission without systemic CS, while 16/64 (25%) failed to enter remission. Within 12 months, 37/64 patients (58%) had prolonged steroid-free remission, while 11/64 (17%) relapsed. During 1 year, 75% of patients receiving oral BDP could avoid systemic CS.


CONCLUSIONS
Oral BDP can avoid the use of systemic CS in the vast majority of patients with mild-moderate UC not responding to 5-ASA and could be considered as a second-line treatment for these patients.
Papi
Claudio
C
Gastroenterology Unit, S. Filippo Neri Hospital, Rome, Italy. c.papi@sanfilipponeri.roma.it
Aratari
Annalisa
A
Moretti
Alessandra
A
Mangone
Manuela
M
Margagnoni
Giovanna
G
Koch
Maurizio
M
Capurso
Lucio
L
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage; D001507:Beclomethasone / Q000008:administration & dosage*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000175:diagnosis* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects / Q000473:pathology; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011336:Probability; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D055815:Young Adult
D001507:Beclomethasone; D001241:Aspirin