Extended-release Multimatrix Budesonide for Microscopic Colitis
The American Gastroenterological Association recommends first-line treatment for microscopic colitis (MC) with budesonide, largely based on 6 randomized controlled trials using the controlled ileal-release formulation of budesonide (CIR-B).1 A recently available extended-release multimatrix formulation of budesonide (MMX-B) (Uceris; Salix Pharmaceuticals, Raleigh, NC) allows drug delivery throughout the colon and may theoretically be more effective than CIR-B for MC. Our aim was to evaluate outcomes in patients with MC treated with MMX-B.
In this case series, all patients evaluated at Mayo Clinic (January 1997–November 2016) with symptoms compatible with active MC and treated with MMX-B were identified. Patients were divided into 2 groups based on their indication for MMX-B: first-line therapy (steroid-naive) and refractory MC (CIR-B nonresponders). Treatment response was defined as no response, partial response, and complete response (Table 1).2
MMX-B was used as first-line therapy in 8 patients and as refractory therapy in 4 patients (Table 1). All patients had negative infectious studies. For both groups, MMX-B decreased the number of daily stools (from 4 to 2 and 6.5 to 3.5 for first-line and refractory use, respectively). All patients responded to first-line MMX-B therapy, with 5 (62.5%) having a complete response and 3 (37.5%) having a partial response. Among refractory patients, 2 (50%) achieved a complete response and 2 (50%) had no response. No side effects were reported.
To our knowledge, this is the first study to describe MMX-B in the management of patients with active MC. The overall response rate was 83.3%, comparable with the 83% rate in previous randomized controlled trials using CIR-B.1 As first-line treatment, MMX-B led to complete or partial response in all patients. Interestingly, half our patients who failed treatment with CIR-B had complete remission with MMX-B.
The efficacy of MMX-B has previously been demonstrated for patients with mild-to-moderate active ulcerative colitis where MMX-B achieved significantly higher combined clinical and endoscopic remission rates compared with placebo (17.4% versus 4.5%, P = 0.005).3 Our study used Uceris (Salix Pharmaceuticals), the MMX-B formulation available in the United States. However, MMX-B is available as Cortiment (Ferring Pharmaceuticals, Saint-Prex, Switzerland) in Europe and worldwide.
In summary, MMX-B appears to be safe and effective as a first-line agent in MC and may have a role in treating MC refractory to traditional budesonide formulations. Although this case series highlights outcomes and side effects associated with MMX-B use in MC, larger case series and randomized controlled trials are necessary before its widespread clinical use.