Budesonide MMX versus prednisolone in mesalamine-refractory mild to moderate ulcerative colitis: a randomized controlled clinical trial

Abstract Background Recently licensed to treat mild or moderate ulcerative colitis (UC), Budesonide MMX is a corticosteroid of the second generation designed to distribute pharmacologically active drugs throughout the colon. Our objective was to compare oral budesonide MMX vs. oral prednisolone in terms of safety and efficacy for treating mild-to-moderate UC cases that are mesalamine-refractory. Methods From April 2022 until April 2024, a randomized controlled study included 50 patients with mesalamine-refractory mild-to-moderate UC, who were randomized to receive either oral budesonide MMX 9 mg ( n = 25) or oral prednisolone 40 mg ( n = 25) for 8 weeks, in addition to mesalamine 3 gm/day. At baseline, week 4, and week 8, clinical, laboratory, and colonoscopic evaluations were carried out. Results Budesonide MMX was superior to prednisolone in inducing clinical remission (88% vs. 60%; p = 0.02), endoscopic remission (56% of the budesonide MMX group achieved Mayo score 0 versus 8% in the prednisolone group, p = 0.004), and histopathological improvement (88% in the budesonide MMX group versus 60% in the prednisolone group, p = 0.02). At week 8, significant improvements in CRP, ESR, and fecal calprotectin were observed in the budesonide MMX group ( p < 0.001, 0.003, and 0.02, respectively). Side effects were more common in the prednisolone group (48%) than the budesonide MMX group (28%), but no statistical differences were observed. Conclusion Compared to prednisolone, budesonide MMX was more effective in inducing clinical and endoscopic remission, histopathological improvement, reducing disease severity, and improving laboratory markers. Both drugs had comparable safety profiles.