Please use this identifier to cite or link to this item:
10.1093/ecco-jcc/jjac081
Title: | Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis : a Randomised, Controlled, Non-inferiority Trial |
Authors: | Kruis, Wolfgang Siegmund, Britta Lesniakowski, Konrad Simanenkov, Vladimir Khimion, Ludmila Sobon, Marcin Delmans, Glebs Maksyashina, Svetlana V. Sablin, Oleg A. Pokrotnieks, Juris Mostovoy, Yuriy Datsenko, Olena Abdulkhakov, Sayar Dorofeyev, Andriy Levchenko, Olena Alexeeva, Olga Andreev, Pavel Kolesnik, Ivan P. Mihaly, Emese Abrahamovych, Orest Baluta, Malgorzata Kharchenko, Nataliia Viacheslav, Neshta Uspenskiy, Yury Vieth, Michael Mohrbacher, Ralf Mueller, Ralph Greinwald, Roland |
Keywords: | budesonide;Clinical trials;rectal foam;rectal suppository;ulcerative proctitis;3.2 Clinical medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database;Gastroenterology |
Issue Date: | 23-Nov-2022 |
Citation: | Kruis , W , Siegmund , B , Lesniakowski , K , Simanenkov , V , Khimion , L , Sobon , M , Delmans , G , Maksyashina , S V , Sablin , O A , Pokrotnieks , J , Mostovoy , Y , Datsenko , O , Abdulkhakov , S , Dorofeyev , A , Levchenko , O , Alexeeva , O , Andreev , P , Kolesnik , I P , Mihaly , E , Abrahamovych , O , Baluta , M , Kharchenko , N , Viacheslav , N , Uspenskiy , Y , Vieth , M , Mohrbacher , R , Mueller , R & Greinwald , R 2022 , ' Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis : a Randomised, Controlled, Non-inferiority Trial ' , Journal of Crohn's & Colitis , vol. 16 , no. 11 , pp. 1714-1724 . https://doi.org/10.1093/ecco-jcc/jjac081 |
Abstract: | 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. |
Description: | Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. |
DOI: | 10.1093/ecco-jcc/jjac081 |
ISSN: | 1873-9946 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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