Latest research on Budesonide

Budesonide is a glucocorticoid used in the management of asthma, the treatment of various skin disorders, and allergic rhinitis. [PubChem] The extended release oral tablet, marketed as Uceris, was FDA approved on January 14, 2013 for the management of ulcerative colitis. Budesonide is provided as a mixture of two epimers (22R and 22S). Interestingly, the 22R form is two times more active than the 22S epimer. The two forms do not interconvert.

Latest findings

Oral Budesonide, a locally active corticosteroid, has been shown in a number of randomised, placebo-controlled trials to induce remission in collagenous colitis. [source, 2016]
Budesonide at a dose of 9 mg/day for 6–8 weeks induces clinical response in 77–100% of patients,3–8 and a recent meta-analysis has confirmed that Budesonide therapy is associated with a threefold improvement in both short-term and long-term clinical responses compared with placebo. [source, 2016]
Budesonide therapy is recommended by the European Microscopic Colitis Group (EMCG) as the treatment of choice for active disease. [source, 2016]
However, after withdrawal of Budesonide 61–88% of patients experience clinical relapse,5 7 10 11 necessitating long-term intervention in patients with a chronic active course. [source, 2016]
Small studies (<50 patients) of up to 6 months’ duration investigating the efficacy of Budesonide at a dose of 6 mg/day in maintaining remission have previously shown a significant benefit versus placebo. [source, 2016]
However, the long-term disease course is not altered by maintenance therapy, as the risk of relapse after 24 weeks’ Budesonide therapy is similar to that observed after 6 weeks’ induction therapy,5 and more long-term data are therefore required. [source, 2016]
Moreover, the optimal Budesonide dose for maintenance therapy remains undefined and no controlled trial has assessed low-dose Budesonide in this setting. [source, 2016]
A prospective, randomised, placebo-controlled trial was initiated by the Swedish Organization for the Study of Inflammatory Bowel Disease (SOIBD) to investigate the efficacy and safety of low-dose oral Budesonide therapy for the long-term maintenance of clinical remission in patients with collagenous colitis. [source, 2016]
The primary objective of the study was to demonstrate the superiority of pH-modified release oral Budesonide (Budenofalk 3 mg capsules, Dr Falk Pharma GmbH, Freiburg, Germany) compared with placebo for maintaining patients with collagenous colitis in clinical remission over a 1-year period. [source, 2016]
The study comprised an initial open-label induction phase with Budesonide therapy for 8 weeks to achieve clinical remission of collagenous colitis. [source, 2016]