For patients with mild to moderate ulcerative proctosigmoiditis or proctitis, the guideline conditionally recommends rectal mesalamine over oral mesalamine. Compared with placebo, rectal mesalamine suppositories were significantly more likely to induce remission in randomized trials of patients with mild to moderate ulcerative proctitis. If these patients cannot tolerate or are refractory to mesalamine suppositories, low-quality evidence supports rectal steroid therapy over no treatment, the guideline states. For patients with mild to moderate ulcerative proctosigmoiditis, moderate-quality evidence supports mesalamine enemas over rectal corticosteroids. If these patients want to avoid the difficulties of enemas, the guideline considers rectal corticosteroid foam a reasonable alternative.
Likewise, they cite low-quality evidence for adding oral prednisone or budesonide MMX to 5-ASA if patients are refractory to optimized 5-ASA therapy. No trials have directly compared rates of remission with budesonide MMX versus systemic corticosteroids. In just one placebo-controlled trial, adding budesonide MMX to 5-ASA slightly improved the chances of remission (risk ratio, 0.95; 95% confidence interval, 0.89-1.00). Furthermore, studies of other second-generation corticosteroids found they were better tolerated but no more likely to induce remission than oral prednisone or prednisolone.
Some patients with mild to moderate colitis respond inadequately to these recommended therapies and need systemic corticosteroids, immunomodulators, or biologic therapies to induce and maintain remission, the guideline authors noted. They make no recommendation on immunomodulators or biologics. Studies of probiotics, curcumin, and fecal microbiota transplantation are “urgently needed,” but for now, their use “risks delaying proven effective therapy, with the potential for worsening symptoms or complications,” they wrote. For patients without Clostridium difficile infections, they recommend against fecal microbiota transplantation except in the setting of a clinical trial.
The experts also noted the need for a tool to stratify patients with mild to moderate ulcerative colitis based on their risk of future progression and colectomy.
Finally, they call for studies on who will benefit most from high-dose mesalamine or topical mesalamine and on the relative safety and efficacy of budesonide and systemic corticosteroids in the event of an inadequate response to 5-ASAs.
All members were required to complete the disclosure statement. These statements are maintained at the American Gastroenterological Association headquarters in Bethesda, Maryland, and pertinent disclosures of conflict of interest are published with this report.
SOURCE: Crocket SD et al. Gastro 2019;156(2). doi: org/10.1053/j.gastro.2018.12.009.