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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.
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.
Afiliación
  • Kruis W; Emeritus Head of Gastroenterology, Ev. Krankenhaus Kalk, University of Cologne, Germany.
  • Siegmund B; Department for Gastroenterology, Infectious diseases and Rheumatology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
  • Lesniakowski K; Department VII of Gastroenterology, Hepatologie and Clinical Nutrition, Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Wroclaw, Poland.
  • Simanenkov V; State Budgetary Healthcare Institution 'City Hospital #26', Saint-Petersburg, Russian Federation.
  • Khimion L; Municipal Institution of Kyiv Regional Rada 'Kyiv Regional Clinical Hospital', Kyiv, Ukraine.
  • Sobon M; Centrum Medyczne Pratia Bydgoszcz, Bydgoszcz, Poland.
  • Delmans G; Endoscopy Department, Daugavpils Regional Hospital, Daugavpils, Latvia.
  • Maksyashina SV; State Public Health Institution 'Novgorod regional clinical hospital', Velikiy Novgorod, Russian Federation.
  • Sablin OA; Federal State Budget Public Health Institution All-Russian centre of Emergency and Radiation medicine n. a., A.M.Nikiforov of Ministry of Emergency Situations of Russia, Saint-Petersburg, Russian Federation.
  • Pokrotnieks J; Pauls Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Centre, Riga, Latvia.
  • Mostovoy Y; Private small-scale enterprise "Pulse", Therapeutical Department, Vinnitsya, Ukraine.
  • Datsenko O; Municipal Institution of Healthcare 'Prof. Shalimova Kharkiv City Clinical Hospital # 2', Kharkiv, Ukraine.
  • Abdulkhakov S; Federal State Budget Educational Institution of High Education 'Kazan State Medical University', Kazan, Russian Federation.
  • Dorofeyev A; Federal State Autonomous Educational Institution of High Education 'Kazan [Volga region] Federal University', Kazan, Russian Federation.
  • Levchenko O; Ukrainian-German Gastroenterology Center 'BYK-Kyiv', Kyiv, Ukraine.
  • Alexeeva O; Municipal Institution 'Odesa Regional Clinical Hospital', Polyclinic department, Odesa, Ukraine.
  • Andreev P; State Public Health Institution 'Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko', Nizhny Novgorod, Russian Federation.
  • Kolesnik IP; Non-state Public Health Institution 'Railway clinical hospital on station Samara' of JSC 'Russian railways', Samara, Russian Federation.
  • Mihaly E; Municipal Institution 'Zaporizhzhya City Clinical Hospital of Urgent Care', Surgery department #3, Zaporizhya, Ukraine.
  • Abrahamovych O; Semmelweis Egyetem ÁOK, II. Belgyógyászati Klinika, Budapest, Hungary.
  • Baluta M; Lviv Regional Clinical Hospital, Gastroenterology department; Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.
  • Kharchenko N; Centrum Medyczne Pratia Gdynia, Gdynia, Poland.
  • Viacheslav N; Kyiv City Clinical Hospital #8, Department of Gastroenterology. P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine.
  • Uspenskiy Y; Municipal Institution 'City Hospital #1', Surgery department, Zaporizhya, Ukraine.
  • Vieth M; Saint-Petersburg State Public Health Institution 'City Hospital of Saint Venerable Martyr Elizabeth', Saint-Petersburg, Russian Federation.
  • Mohrbacher R; Friedrich-Alexander-University Erlangen-Nuremberg, Klinikum Bayreuth, Institute of Pathology, Bayreuth, Germany.
  • Mueller R; Dr. Falk Pharma GmbH, Clinical Research and Development, Freiburg, Germany.
  • Greinwald R; Dr. Falk Pharma GmbH, Clinical Research and Development, Freiburg, Germany.
J Crohns Colitis ; 16(11): 1714-1724, 2022 Nov 23.
Article en En | MEDLINE | ID: mdl-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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proctitis / Colitis Ulcerosa Tipo de estudio: Clinical_trials / Etiology_studies Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Alemania

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proctitis / Colitis Ulcerosa Tipo de estudio: Clinical_trials / Etiology_studies Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Alemania