Kruis, Wolfgang, Siegmund, Britta ORCID: 0000-0002-0055-958X, 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, Neshta, Viacheslav, Uspenskiy, Yury, Vieth, Michael, Mohrbacher, Ralf, Mueller, Ralph and Greinwald, Roland (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. J. Crohns Colitis, 16 (11). S. 1714 - 1725. OXFORD: OXFORD UNIV PRESS. ISSN 1876-4479

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kruis, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siegmund, BrittaUNSPECIFIEDorcid.org/0000-0002-0055-958XUNSPECIFIED
Lesniakowski, KonradUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simanenkov, VladimirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Khimion, LudmilaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sobon, MarcinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delmans, GlebsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maksyashina, Svetlana, VUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sablin, Oleg A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pokrotnieks, JurisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mostovoy, YuriyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Datsenko, OlenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Abdulkhakov, SayarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dorofeyev, AndriyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Levchenko, OlenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alexeeva, OlgaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Andreev, PavelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolesnik, Ivan P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mihaly, EmeseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Abrahamovych, OrestUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baluta, MalgorzataUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kharchenko, NataliiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neshta, ViacheslavUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uspenskiy, YuryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vieth, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mohrbacher, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, RalphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Greinwald, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-696418
DOI: 10.1093/ecco-jcc/jjac081
Journal or Publication Title: J. Crohns Colitis
Volume: 16
Number: 11
Page Range: S. 1714 - 1725
Date: 2022
Publisher: OXFORD UNIV PRESS
Place of Publication: OXFORD
ISSN: 1876-4479
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
EVIDENCE-BASED CONSENSUS; SHORT HEALTH SCALE; 5-AMINOSALICYLIC ACID; SUBJECTIVE HEALTH; COLITIS; ENEMA; DIAGNOSIS; MANAGEMENT; GUIDELINES; EFFICACYMultiple languages
Gastroenterology & HepatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69641

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