Colon to Rectum
J Crohns Colitis. 2022;16(11):1714–24
Novel budesonide suppository and standard budesonide rectal foam induce high rates of clinical remission and mucosal healing in active ulcerative proctitis: A randomized, controlled, non-inferiority trial
Background and aims: Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient’s preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild-to-moderate ulcerative proctitis.
Methods: This was a randomized, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4-mg suppository or budesonide 2-mg foam once daily for 8 weeks. The coprimary end points were changes from baseline to week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index (UC-DAI) subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion, the authors additionally analyzed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient’s preference, physician’s global assessment, and quality of life were also assessed and analyzed.
Results: Overall, 286 and 291 patients were included in the 4-mg suppository and 2-mg foam groups, respectively. Budesonide 4-mg suppository met the prespecified criterion for non-inferiority to the 2-mg foam in both coprimary end points of clinical remission and mucosal healing. Secondary end points consistently supported the non-inferiority of the suppository. Trends in favor of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam.
Conclusions: In patients with ulcerative proctitis, budesonide 4-mg suppository was non-inferior to budesonide 2-mg foam in efficacy, and both were safe and well tolerated.