Article Text

Download PDFPDF
Drug development for ulcerative proctitis: current concepts
  1. Bénédicte Caron1,
  2. William J Sandborn2,
  3. Stefan Schreiber3,
  4. Remo Panaccione4,
  5. Silvio Danese5,
  6. Laurent Peyrin-Biroulet1
  1. 1 Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France
  2. 2 Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
  3. 3 Department of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany
  4. 4 Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
  5. 5 Department of Biomedical Sciences, Humanitas Clinical Research Center-IRCCS and Humanitas University, Milan, Italy
  1. Correspondence to Dr Laurent Peyrin-Biroulet, Department of Gastroenterology, University of Lorraine, Nancy, France; peyrinbiroulet{at}

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterised by intestinal inflammation limited to the rectum and colonic mucosa.1 At presentation, approximately 30% of patients have inflammation involving the rectum only, termed ulcerative proctitis (UP).2 3 Proximal extension of UP may occur in up to 28% of patients after 5 years follow-up with progression to extensive colitis in 49% of cases.4–8 A population-based study of paediatric-onset UC demonstrated that 25% of patients with paediatric UC had UP at diagnosis and 49% of them presented a colonic extension at maximal follow-up.9

UP is specifically defined by the disease not extending not beyond the rectum (ie, proximal extent of inflammation is distal to the rectosigmoid junction).10 However, there is no universal standard for defining UP. The Montreal classification divides the distribution of UC only into UP (E1: limited to the rectum), left-sided colitis (E2: up to the splenic flexure) and extensive colitis (E3: beyond splenic flexure).11 12 American Gastroenterological Association (AGA) Institute Guidelines defined proctitis as an in inflammation limited to the rectum or <15–20 cm from anus.13

Clinical symptoms vary based of disease extent.14 UP is responsible for distressing symptoms including increased rectal bleeding, tenesmus, urgency, faecal leakage, faecal incontinence and reduced quality of life.4 6 The presence of diarrhoea is variable, and in fact up to 20–30% of patients are have delayed transit and are constipated.14 15 The presence of constipation in patients with UC is associated with women, active disease and distal colon involvement.15 Such data are lacking in patients with UP. Medical management of these patients may be challenging, in part because only limited data are available on the treatment of UP.5 16 The therapeutic approach in patients with UC and specifically UP mainly …

View Full Text


  • Contributors LP-B conceived the study. BC wrote the article and created tables and figure. WJS, SS, RP, SD, and LP-B critically reviewed the content of the paper. The manuscript was approved by all authors.

  • Funding William Sandborn is supported in part by the NIDDK-funded San Diego Digestive Diseases Research Center (P30 DK120515).

  • Competing interests WJS reports: research grants from Abbvie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, Glaxo Smith Kline, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, Theravance Biopharma; consulting fees from Abbvie, Abivax, Admirx, Alfasigma, Alimentiv (previously Robarts Clinical Trials, owned by Alimentiv Health Trust), Alivio Therapeutics, Allakos, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Bausch Health (Salix), Beigene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Cellularity, Cosmo Pharmaceuticals, Escalier Biosciences, Equillium, Forbion, Genentech/Roche, Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyverna Therapeutics, Landos Biopharma, Lilly, Oppilan Pharma, Otsuka, Pandion Therapeutics, Pfizer, Progenity, Prometheus Biosciences, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, UCB, Vendata Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, Zealand Pharma; and stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma, Prometheus Biosciences, Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Biosciences. Spouse: Iveric Bio—consultant, stock options; Progenity—stock; Oppilan Pharma—consultant, stock options; Prometheus Biosciences—employee, stock, stock options; Ventyx Biosciences—stock, stock options; Vimalan Biosciences—stock, stock options. SS reports speaker, advisory and consulting roles for AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Eisai Medical Research, Eli Lilly, Ferring, Genentech, Gilead, Janssen, Merck, Pfizer, Shire Pharmaceuticals, Sandoz, Takeda, Tillotts, RP reports Consultant for: AbbVie, AGI Therapeutics, Alba Therapeutics, Amgen, Astellas, Athersys, Atlantic Healthcare, BioBalance, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eisai Medical Research, Elan, EnGene, Eli Lilly, Enteromedics, Ferring, Flexion Therapeutics, Genentech, Genzyme, Gilead, Given Imaging, GlaxoSmithKline, Human Genome Sciences, Ironwood, Janssen, Merck & Co., Merck Research Laboratories, MerckSerono, Nisshin Kyorin, Novo Nordisk, NPS Pharmaceuticals, Optimer, Orexigen, PDL Biopharma, Pfizer, Procter and Gamble, Santarus, Shire Pharmaceuticals, Sigmoid Pharma, Sirtris (a GSK company), Sandoz, S.L.A. Pharma (UK), Targacept, Teva, Therakos, Tillotts, TxCell SA, Speaker’s fees for Abbvie, Amgen, Celgene, Ferring, Janssen, Merck, Novartis, Pfizer, Prometheus, Sandoz, Shire, Takeda Advisory board attendance for Abbvie, Abbott, Allergan, Amgen,Biogen Idec, Eisai, Ferring, Genentech, Janssen, Merck, Shire, Elan, GlaxoSmithKline, Hospira, Pfizer, Bristol-Myers Squibb, Takeda, Cubist, Celgene, Salix, Roche. Research/educational support from Abbvie, Ferring, Janssen, Shire Takeda. SD has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. LP-B has served as a speaker, consultant and advisory board member for Merck, Abbvie, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Hospira/Pfizer, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, HAC Pharma, Index Pharmaceuticals, Amgen, Sandoz, Forward Pharma GmbH, Celgene, Biogen, Lycera, Samsung Bioepis, Theravance.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.