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Randomized Controlled Trial
. 2022 Nov 23;16(11):1714-1724.
doi: 10.1093/ecco-jcc/jjac081.

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

Wolfgang Kruis  1 , Britta Siegmund  2 , Konrad Lesniakowski  3 , Vladimir Simanenkov  4 , Ludmila Khimion  5 , Marcin Sobon  6 , Glebs Delmans  7 , Svetlana V Maksyashina  8 , Oleg A Sablin  9 , Juris Pokrotnieks  10 , Yuriy Mostovoy  11 , Olena Datsenko  12 , Sayar Abdulkhakov  13   14 , Andriy Dorofeyev  15 , Olena Levchenko  16 , Olga Alexeeva  17 , Pavel Andreev  18 , Ivan P Kolesnik  19 , Emese Mihaly  20 , Orest Abrahamovych  21 , Malgorzata Baluta  22 , Nataliia Kharchenko  23 , Neshta Viacheslav  24 , Yury Uspenskiy  25 , Michael Vieth  26 , Ralf Mohrbacher  27 , Ralph Mueller  27 , Roland Greinwald  27
Affiliations
Randomized Controlled Trial

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

Wolfgang Kruis et al. J Crohns Colitis. .

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.

Keywords: Clinical trials; budesonide; rectal foam; rectal suppository; ulcerative proctitis.

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Figures

Figure 1.
Figure 1.
CONSORT disposition diagram. *Safety Set. **For details please see Table 1. ***One patient left the study due to an uncertain pregnancy test but was defined as delayed exclusion, even though ‘uncertain pregnancy test’ was not specified in the study protocol as one of the criteria for delayed exclusion.
Figure 2.
Figure 2.
Primary Analysis of remission rates for clinical remission and mucosal healing by the end of treatment or discontinuation [PPS and FAS]. Clinical remission was defined as having a UC-DAI stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mucosal healing was defined as having a mucosal appearance subscore of 0 or 1; p-value: Farrington–Manning test [one-sided] with non-inferiority margin = 10%. PPS, per-protocol set; FAS, full analysis set; UC-DAI, Ulcerative Colitis-Disease Activity Index.
Figure 3.
Figure 3.
Patients’ overall acceptance of budesonide rectal suppository [4 mg] and foam [2 mg], full analysis set [FAS].
See this image and copyright information in PMC

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