Olena Levchenko, Roland Greinwald, Ralph Mueller, Ralf Mohrbacher, Michael Vieth, Yury Uspenskiy, Neshta Viacheslav, Nataliia Kharchenko, Malgorzata Baluta, Orest Abrahamovych, Emese Mihaly, Ivan P Kolesnik, Pavel Andreev, Olga Alexeeva, Wolfgang Kruis, Andriy Dorofeyev, Sayar Abdulkhakov, Olena Datsenko, Yuriy Mostovoy, Juris Pokrotnieks, Oleg A Sablin, Svetlana V Maksyashina, Glebs Delmans, Marcin Sobon, Ludmila Khimion, Vladimir Simanenkov, Konrad Lesniakowski, Britta Siegmund
Journal: Journal of Crohn's & colitis 2022;16(11):1714-1724
PMID: 35709376
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 randomised, 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 co-primary endpoints 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, we additionally analysed 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 analysed.
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 co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour 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.
© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
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