Systematic review: second-generation vs. conventional corticosteroids for induction of remission in ulcerative colitis

Abstract

Background: Oral corticosteroids are the mainstay treatment for induction of ulcerative colitis remission in patients failing or intolerant to aminosalicylate therapy, but the poor tolerability profile of these drugs limits their usefulness. Second-generation, gut-selective corticosteroids may offer a safe alternative to systemic agents. Aim: To review the efficacy and safety of systemic and second-generation oral corticosteroids for the induction of remission in ulcerative colitis. Methods: The PubMed database was searched for randomised, controlled, and open-label trials of orally administered corticosteroids published between January 1950 and September 2015. Additional trials were identified from review of citation lists. Trials that compared oral corticosteroids with non-oral agents or in combination with agents other than aminosalicylates were excluded. Results: Of the 240 studies identified, 21 were eligible for inclusion. Few trials directly compared oral systemic and second-generation corticosteroids (n = 4). Some second-generation corticosteroids had questionable efficacy vs. placebo or mesalazine (mesalamine), but beclomethasone dipropionate and budesonide MMX demonstrated a comparative benefit. Only beclomethasone dipropionate was similar to conventional corticosteroids for induction of remission and other clinical endpoints. Direct comparative trials for budesonide MMX were unavailable. Second-generation corticosteroids had an overall favourable safety profile, with minimal adverse effects on cardiovascular and metabolic parameters and a low incidence of adverse events. Conclusions: Beclomethasone dipropionate and budesonide MMX provide greater induction of remission in ulcerative colitis than placebo or mesalazine but additional active-comparator trials are needed to firmly establish the efficacy profile vs. systemic corticosteroids. Second-generation corticosteroids have a more favourable safety and tolerability profile than systemic corticosteroids.