{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T03:16:20Z","timestamp":1792725380148,"version":"4.5.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2022,6,16]],"date-time":"2022-06-16T00:00:00Z","timestamp":1655337600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100020406","name":"Dr. Falk Pharma GmbH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100020406","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,11,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background and Aims<\/jats:title>\n                  <jats:p>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\u2019s 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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\u2019s preference, physician\u2019s global assessment, and quality of life were also assessed and analysed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjac081","type":"journal-article","created":{"date-parts":[[2022,6,16]],"date-time":"2022-06-16T19:19:25Z","timestamp":1655407165000},"page":"1714-1724","source":"Crossref","is-referenced-by-count":16,"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"],"prefix":"10.1093","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9465-0124","authenticated-orcid":false,"given":"Wolfgang","family":"Kruis","sequence":"first","affiliation":[{"name":"Emeritus Head of Gastroenterology, Ev. Krankenhaus Kalk, University of Cologne , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0055-958X","authenticated-orcid":false,"given":"Britta","family":"Siegmund","sequence":"additional","affiliation":[{"name":"Department for Gastroenterology, Infectious diseases and Rheumatology, Campus Benjamin Franklin, Charit\u00e9 - Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin , Berlin , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konrad","family":"Lesniakowski","sequence":"additional","affiliation":[{"name":"Department VII of Gastroenterology, Hepatologie and Clinical Nutrition, Wojew\u00f3dzki Szpital Specjalistyczny im. J. Gromkowskiego , Wroclaw , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Simanenkov","sequence":"additional","affiliation":[{"name":"State Budgetary Healthcare Institution \u2018City Hospital #26\u2019 , Saint-Petersburg , Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludmila","family":"Khimion","sequence":"additional","affiliation":[{"name":"Municipal Institution of Kyiv Regional Rada \u2018Kyiv Regional Clinical Hospital\u2019 , Kyiv , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcin","family":"Sobon","sequence":"additional","affiliation":[{"name":"Centrum Medyczne Pratia Bydgoszcz , Bydgoszcz , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glebs","family":"Delmans","sequence":"additional","affiliation":[{"name":"Endoscopy Department, Daugavpils Regional Hospital , Daugavpils , Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana V","family":"Maksyashina","sequence":"additional","affiliation":[{"name":"State Public Health Institution \u2018Novgorod regional clinical hospital\u2019 , Velikiy Novgorod , Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleg A","family":"Sablin","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juris","family":"Pokrotnieks","sequence":"additional","affiliation":[{"name":"Pauls Stradins Clinical University Hospital, Gastroenterology, Hepatology and Nutrition Centre , Riga , Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuriy","family":"Mostovoy","sequence":"additional","affiliation":[{"name":"Private small-scale enterprise \u201cPulse\u201d, Therapeutical Department , Vinnitsya , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olena","family":"Datsenko","sequence":"additional","affiliation":[{"name":"Municipal Institution of Healthcare \u2018Prof. Shalimova Kharkiv City Clinical Hospital # 2\u2019 , Kharkiv , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sayar","family":"Abdulkhakov","sequence":"additional","affiliation":[{"name":"Federal State Budget Educational Institution of High Education \u2018Kazan State Medical University \u2019, Kazan , Russian Federation"},{"name":"Federal State Autonomous Educational Institution of High Education \u2018Kazan [Volga region] Federal University\u2019 , Kazan , Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andriy","family":"Dorofeyev","sequence":"additional","affiliation":[{"name":"Ukrainian-German Gastroenterology Center \u2018BYK-Kyiv\u2019 , Kyiv , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olena","family":"Levchenko","sequence":"additional","affiliation":[{"name":"Municipal Institution \u2018Odesa Regional Clinical Hospital\u2019, Polyclinic department , Odesa , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Alexeeva","sequence":"additional","affiliation":[{"name":"State Public Health Institution \u2018Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko\u2019 , Nizhny Novgorod , Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavel","family":"Andreev","sequence":"additional","affiliation":[{"name":"Non-state Public Health Institution \u2018Railway clinical hospital on station Samara\u2019 of JSC \u2018Russian railways\u2019 , Samara , Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan P","family":"Kolesnik","sequence":"additional","affiliation":[{"name":"Municipal Institution \u2018Zaporizhzhya City Clinical Hospital of Urgent Care\u2019, Surgery department #3 , Zaporizhya , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emese","family":"Mihaly","sequence":"additional","affiliation":[{"name":"Semmelweis Egyetem \u00c1OK, II. 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