Efficacy and Safety of Oral Prednisolone and Budesonide MMX for Outpatient Induction Therapy in Active Ulcerative Colitis: A Multicenter Retrospective Cohort Study.

Background/

Objectives

Oral prednisolone (PSL) and budesonide multi-matrix (BUD-MMX) are used to induce remission in ulcerative colitis (UC); however, their therapeutic positioning remains unclear. Comparative data from real-world practices are limited. This study assessed the efficacy and safety of PSL and BUD-MMX in patients with active UC.

Methods

Consecutive outpatients with UC initiated on oral PSL or BUD-MMX at two tertiary referral centers were included. The primary outcome was clinical remission at week 8, defined as a partial Mayo score (PMS) ≤ 1 with a rectal bleeding subscore of 0. Secondary outcomes included clinical response and safety. Pre-specified subgroup analyses were performed according to baseline disease activity.

Results

Sixty PSL-treated and 40 BUD-MMX-treated patients were evaluated at week 8. Clinical remission was achieved in 65.0% and 55.0% of the PSL and BUD-MMX groups, respectively, whereas a clinical response was observed in 75.0% and 62.5%, respectively. No patient with a baseline PMS of 2-3 was initiated on PSL. Among patients with a baseline PMS of 4-5, the remission and response rates at week 8 were similar between the groups. In contrast, remission in patients with a baseline PMS ≥ 6 was numerically lower in the BUD-MMX group. Treatment escalation rates were comparable in the overall cohort, whereas adverse events were more frequent in the PSL group (23.3% vs. 2.4%).

Conclusions

Treatment selection between PSL and BUD-MMX appeared to reflect baseline disease activity, with a partial overlap in the moderate clinical range. BUD-MMX may be a reasonable initial option for selected patients.