{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T14:38:48Z","timestamp":1783348728394,"version":"3.54.6"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T00:00:00Z","timestamp":1573689600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JGH Open"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec><jats:title>Background and Aims<\/jats:title><jats:p>Rectal ulcerative colitis (UC) and Crohn's disease (CD) often do not respond to conventional therapies. Oral and suppository tacrolimus are effective but often poorly tolerated or are complex to formulate. Tacrolimus is topically active, water soluble, and has minimal systemic toxicity when administered rectally; we therefore tested a simple tap water\u2010based enema formulation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Tacrolimus powder from 1 mg capsules and tap water in a 60\u2009mL syringe were delivered rectally. The primary end\u2010point was endoscopic response (UC: MAYO score reduction by one point; CD: improvement in ulcer number and severity). Secondary end\u2010points included endoscopic remission, clinical response, stool frequency, and rectal bleeding.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventeen patients [12 UC, five CD, nine female, median age 31\u2009years] with refractory rectal disease were treated. The majority of patients had failed immunosuppressive therapy [88% thiopurine; 71% biologic therapy]. Initial enemas included 1\u20134 mg tacrolimus daily and 1\u20133 mg tacrolimus maintenance three times a week for a median of 20\u2009weeks (range 3\u2013204). Concomitant thiopurine or biologic therapy continued. 94% tolerated therapy. Of 12 UC patients, eight (67%) achieved endoscopic remission, one further patient achieved endoscopic response, and median partial MAYO scores decreased (pre:4 vs. post:2; <jats:italic>P<\/jats:italic> =\u20090.010). Of five CD patients, three (60%) achieved endoscopic response, two (40%) endoscopic remission, and three (60%) clinical response. Stool frequency, rectal bleeding, and C\u2010reactive protein levels improved. Strictures became endoscopically passable in all four affected patients. No major adverse events were reported, and four patients had disease flare.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Tacrolimus enemas are easy to prepare, well tolerated, effective, and safe. They should be included in the treatment armamentarium for inflammatory bowel disease\u2010related refractory proctitis.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jgh3.12280","type":"journal-article","created":{"date-parts":[[2019,11,15]],"date-time":"2019-11-15T06:24:55Z","timestamp":1573799095000},"page":"561-564","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Simple water\u2010based tacrolimus enemas for refractory proctitis"],"prefix":"10.1002","volume":"4","author":[{"given":"Sasha R.","family":"Fehily","sequence":"first","affiliation":[{"name":"Department of Gastroenterology St Vincent's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9909-0250","authenticated-orcid":false,"given":"Felicity C.","family":"Martin","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology St Vincent's Hospital  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3319-7199","authenticated-orcid":false,"given":"Michael A.","family":"Kamm","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology St Vincent's Hospital  Melbourne Victoria Australia"},{"name":"University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,14]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.4.4.299"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.6.2.99"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04619.x"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2000.02180.x"},{"key":"e_1_2_5_6_1","first-page":"1867","article-title":"A double\u2010blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis","volume":"92","author":"Safdi M","year":"1997","journal-title":"Am. 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