Use, effectiveness and tolerability of budesonide‐MMX in ulcerative colitis: A real‐life experience

Abstract

Background Budesonide-MMX has an established role in the management of relapsing mild-to-moderate ulcerative colitis. Data regarding effectiveness and tolerability in real-life clinical practice are limited. Aim The aim of this study was to assess the use of budesonide-MMX in ulcerative colitis, as well as short-term effectiveness and tolerability in real-life practice. Methods We conducted a retrospective study of adult patients with mild-to-moderate ulcerative colitis treated with budesonide-MMX at four tertiary inflammatory bowel disease centres in Italy from June 2016 to February 2018. Demographic and clinical features of patients, the use of budesonide-MMX, disease course and concomitant therapy were recorded. The primary outcome assessed was clinical remission at 2 months. Results A total of 82 patients with active mild-to-moderate ulcerative colitis were included in the study with a mean age of 45.9 years and a median partial Mayo Score of 4 (interquartile range 3–5). A total of 41 patients were male. Overall, 36 had extensive colitis, 38 left-sided colitis and eight proctitis. Treatments at the time of inclusion included 10 patients receiving biologic therapy, seven azathioprine and 54 mesalazine or salazopyrin. The main reasons for the addition of budesonide-MMX were clinical relapse (47.5%) or inadequate response to current therapy (39.0%). In total, 50% of patients achieved clinical remission, whereas 9.8% had clinical improvement. No response was noted in 40.2% of subjects. Using multivariate binary logistic regression, a moderate degree of activity was the main independent predictor of non-response. Eight significant adverse effects were reported in six patients with three discontinuing treatment. Conclusion In real-life clinical practice, budesonide-MMX is commonly used in combination with other therapies, both for acute disease flares and for partial response to therapy.

Moving from efficacy to effectiveness: budesonide multimatrix in ulcerative colitis

“…These percentages are similar to those reported by Danese et al 14 . (52% and 8%, respectively) on the population receiving budesonide‐MMX, in monotherapy or co‐administered with 5‐ASA, yet the indexes used for measuring disease activity differed (ulcerative colitis disease activity index 14 and Mayo score) 15 . In agreement with previous trials, the drug was well tolerated.…”

“…The other publication, by Maconi and colleagues, 15 is a retrospective multicentre study of 82 adult patients with mild‐to‐moderate UC. That study evaluated the use of budesonide‐MMX mostly as add‐on therapy (91.5% of the patients, 66% of which were concomitantly treated with mesalazine).…”

Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis

“…A network meta-analysis of 15 randomized controlled trials corroborated these data showing that budesonide MMX 9 mg and mesalamine >2.4 g/day were equivalent for inducing clinical and endoscopic remission (OR = 0.97, 95% CI: 0.59–1.60) [ 68 ]. Additionally, two observational cohort studies provided evidence in a real-world setting [ 69 , 70 ]. In a retrospective multicentre study including 82 patients with mild-to-moderate UC, 50% of patients treated with budesonide MMX achieved clinical remission and a further 9.8% had a clinical improvement [ 69 ].…”

“…Additionally, two observational cohort studies provided evidence in a real-world setting [ 69 , 70 ]. In a retrospective multicentre study including 82 patients with mild-to-moderate UC, 50% of patients treated with budesonide MMX achieved clinical remission and a further 9.8% had a clinical improvement [ 69 ]. Interestingly, most patients (54/82 = 66%) received budesonide MMX as an add-on drug suggesting that combination therapy might be a valid therapeutic approach [ 69 ].…”

“…In a retrospective multicentre study including 82 patients with mild-to-moderate UC, 50% of patients treated with budesonide MMX achieved clinical remission and a further 9.8% had a clinical improvement [ 69 ]. Interestingly, most patients (54/82 = 66%) received budesonide MMX as an add-on drug suggesting that combination therapy might be a valid therapeutic approach [ 69 ]. In a multicentre prospective study by Danese et al, clinical outcomes were improved among patients receiving combination therapy (cohort 1 and 2) compared to that among those receiving budesonide MMX monotherapy (cohort 3) [ 70 ].…”