ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment

Ulcerative colitis [UC] is a chronic inflammatory bowel disease [IBD] characterised by colonic inflammation extending to a variable extent from the rectum. Care of the patient with UC requires appropriate input from across the multiprofessional team. These guidelines summarise the recommended medical treatment for adults with UC. Other ECCO guidelines consider the approach to UC diagnosis and monitoring,1–3 nursing care,4 management of disease complications,5–7 risk of infection,8 and technical aspects of surgery.9 This document was prepared as part of a process that also led to the publication of a related guideline with recommendations on the surgical care of the patients with UC and on the medical aspects of the management of the patient hospitalised with severe UC. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Surgical Treatment. Patients living with UC can have a variable disease course.10 In this document, we discuss therapeutic approaches stratified by disease severity [mildly-to-moderately active and moderately-to-severely active disease]. Attempts to define disease severity are widely used in setting clinical trial inclusion criteria and can be measured according to several different definitions.11 Trial populations will inevitably vary, and we reflect the continuum of disease severity by having the moderate disease category span both broad categories. It is also important to remember that these definitions capture severity at a given point in time and may not reflect the cumulative long-term burden of disease experienced by a patient.12 It is also important to consider disease extent when planning treatment in UC, as this may affect the optimal route of drug administration. This is typically defined according to disease involving the rectum only [proctitis], disease distal to the splenic flexure [left-sided UC], or disease extending proximal to the splenic flexure [extensive UC].13 These definitions of disease extent are recognised as somewhat arbitrary; in clinical practice, topically administered therapies are often used for UC whose extent is limited to the rectum and a portion of the sigmoid colon [proctosigmoiditis], with the term ‘distal colitis’ used to describe this disease distribution. It should be remembered that disease distribution can change10,14 and that proximal disease extension can be a negative prognostic marker.15 This document was compiled following the ‘Grading of Recommendations Assessment, Development, and Evaluation’ [GRADE] methodology.16 A panel of 33 experts was selected by the Guidelines Committee of ECCO from a competitive pool of applicants and worked with a team of methodologists and librarians. All panellists received training in the GRADE methodology. Additionally, six patients with UC, representing the European Federation of Crohn’s and Colitis Associations [EFCCA], were invited to participate in all face-to-face meetings as full voting members. Two domains for the medical treatment of UC were identified and used as the basis for the following two working groups based upon disease severity: mildly-to-moderately active disease and moderately-to-severely active disease. We recognise that these divisions are somewhat arbitrary, partially overlapping, and inconsistently defined; therefore, we ensured close collaboration between the working groups to ensure that key topics were covered appropriately with the aim of providing guidance applicable across the continuum of UC severity encountered in clinical practice. Working group participants first formulated a series of specific questions using the Population, Intervention, Comparator, Outcomes [PICO] system, which were deemed to be clinically important for the medical treatment of UC. These questions were debated in a series of telephone conferences before final agreement at a meeting of the full guideline group in Vienna in November 2019. Voting on the inclusion of PICO questions was conducted, and only those achieving agreement of >80% by the panel were included in the next phase of the process. At this meeting, the panellists also ranked each outcome’s importance on a scale of 1 to 9 based on the GRADE definitions.16 Scores of 7‒9 indicated an outcome that is critical to patients for decision making; scores of 4‒6 indicated an important outcome, but not critical; and scores of 1‒3 indicated an outcome of limited importance. The panellists’ agreement on outcomes’ importance was assessed using the Disagreement Index, as described in the RAND/UCLA appropriateness method.17 The team of librarians performed a comprehensive literature search on PubMed/Medline, Embase, and the Cochrane Central databases, using specific search strings for each PICO question [available as Supplementary data at ECCO-JCC online]. Two working group members [one assigned to the PICO question and another from the same group as second reviewer] independently screened titles and abstracts to exclude any irrelevant reports. Subsequently, the working group members assigned to each PICO question assessed the full text of the selected publications for relevance to the specific PICO. Note that were only selected the PICO as data on at of the of for the of the In this that of a drug of were not included for not at outcome defined as of critical importance. of the the guidelines in this document from in patients with UC. 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