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Published online February 18, 2020.
Who should continue the budesonide 2-mg foam treatment for up to week 6 in patients with mild-to-moderate distal ulcerative colitis?
Predictive factors for achievement of mucosal healing by budesonide 2-mg foam in ulcerative colitis: a pooled analysis of data from two clinical trials
Toshifumi Hibi, Makoto Naganuma, Eisei Oda, et al. Intest Res. 2020;18(1):56-68.

Topical therapy is recommended for the mild-to-moderate distal lesions of ulcerative colitis. Foam preparations have advantages of less leakage due to high retention than a liquid enemas and wider distribution than a suppository. The use of budesonide 2-mg foam (BF) twice-daily showed superiority for attaining mucosal healing (MH) after 6 weeks compared to placebo, however, inconvenient administration than that of oral medication may lead to low compliance of the patients. The present study analyzed the prognostic factors for mucosal healing at 6 weeks of BF treatment by a post hoc analysis of the pooled data from 2 clinical trials and intended to help determine the adequacy of treatment continuation.





  1. In this study, 119 patients in the BF twice-daily group (B group) and 117 in the placebo group (P group) were included in the full analysis set up to week 6. The MH at week 6 in groups B and P were 39.5% and 4.3%, respectively (P<0.0001). The proportions of a rectal bleeding (RB) subscore of 0 after 5 days of treatment (p<0.05) and a stool frequency (SF) subscore of 0 after 2 days of treatment (p<0.05) were significantly higher in group B than in group P, respectively.
  2. Multivariate analysis revealed that lower baseline SF subscore (p=0.0050) and history of topical 5-ASA use (p=0.0008) were independently associated with MH at week 6 in group B, respectively.
  3. Patients with a low¬er RB subscore during BF treatment had a significantly higher rate of MH at week 6 (week 2, p=0.0033; week 4, p=0.0018; week 6, 0.0002). This suggests the need to decide whether to continue BF treatment in patients with a higher RB subscore at week 2 and/or 4.

Read more about the efficacy and the prognostic factors of remission of budesonide foam for mild-to-moderate distal ulcerative colitis.


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