Efficacy of Pharmacological Agents for Ulcerative Proctitis: A Systematic Literature Review

J Crohns Colitis. 2022 Jul 14;16(6):922-930. doi: 10.1093/ecco-jcc/jjab218.


Bénédicte Caron 1William J Sandborn 2Remo Panaccione 3Stefan Schreiber 4Ailsa Hart 5Virginia Solitano 6Silvio Danese 7Laurent Peyrin-Biroulet 1


Author information

1Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France.

2Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.

3Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.

4Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany.

5Inflammatory Bowel Diseases Unit, St Mark's Hospital, Harrow, UK.

6Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

7Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy.


Background: Ulcerative proctitis is a common and often highly symptomatic form of inflammatory bowel disease. We performed a systematic review to assess the efficacy of different therapies in the management of patients with ulcerative proctitis.

Methods: We identified randomized controlled trials in adults with ulcerative proctitis treated with oral or topical therapies for induction of response or remission, or prevention of relapse.

Results: A total of 32 randomized controlled trials were included [27 induction/2839 participants, five maintenance/334 participants]. Follow-up varied from 3 to 8 weeks for induction, and from 6 to 24 months for maintenance of remission. 5-Aminosalicylic acid [5-ASA] suppository was the most frequently evaluated treatment [14/32, 43.7%], followed by steroid enema [7/32, 21.9%]. Topical 5-ASA demonstrated effectiveness for induction of clinical response or remission and prevention of relapse in several studies. Combined topical steroids and 5-ASA was more effective than topical 5-ASA or topical steroids alone to induce response [100% of patients for combination vs 70% for beclomethasone alone and 76% for 5-ASA alone]. One observational study suggested azathioprine may be effective in patients with ulcerative proctitis. Only two cohort studies evaluated the efficacy of tumour necrosis factor inhibitors in ulcerative proctitis. Small molecules, anti-integrins and anti-interleukin therapies have not been evaluated in isolated ulcerative proctitis.

Conclusion: The role of topical 5-ASA as a treatment for ulcerative proctitis has been confirmed in this systematic literature review, for induction and maintenance of remission. Future trials are needed to investigate the efficacy of more recent and upcoming drug classes in patients with ulcerative proctitis.



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