Management of Moderate to Severe Ulcerative Colitis Guideline Summary

Publication Date: November 19, 2024
Last Updated: November 21, 2024

Key Considerations

  • Patients should have confirmation of active inflammation based on UC-related symptoms, biomarkers, and/or endoscopic evaluation before starting advanced therapies.
  • Patients should have both general and therapy-specific pretreatment workup before initiation of such treatments. These include screening for hepatitis B and tuberculosis exposure before any biologic or advanced small molecule treatments, thiopurine methyl transferase testing before initiation of thiopurines, and a baseline electrocardiogram before use of S1P receptor modulators. There are other treatment- and patient-specific tests that should be performed in accordance with the labels from regulatory agencies.
  • It is important to evaluate for factors influencing risk of treatment-related complications, including assessment of comorbidities, frailty, and functional status and concomitant medications, and assessment of thromboembolic and cardiovascular risk factors.
  • In order to decrease risk of serious infections with immunosuppressive therapies, vaccination against influenza, pneumococcal pneumonia, and herpes zoster (particularly before S1P receptor modulator or JAK inhibitor use) should be considered.
  • Initiation of advanced therapy should be followed by monitoring for symptomatic response within 3 mo of initiation, symptomatic and biochemical remission within 3–6 mo, and endoscopic improvement/ remission within 6–12 mo.
  • On-treatment monitoring for potential toxicity from immunosuppressive therapies, such as periodic monitoring of hemogram, chemistries, and transaminases, should be performed, according to drug label.

Summary of Recommendations

In adult outpatients with moderate-to-severe UC, the AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab and guselkumab over no treatment. (moderate to high certainty) ( High , Strong )
612
In adult outpatients with moderate-to-severe UC, the AGA suggests the use of adalimumab, filgotinib or mirikizumab over no treatment. ( Moderate , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC who are naïve to advanced therapies, the AGA suggests using a HIGHER efficacy medication (infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, guselkumab) OR an INTERMEDIATE efficacy medication (golimumab, ustekinumab, tofacitinib, filgotinib, mirikizumab), rather than a LOWER efficacy medication (adalimumab). ( Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, the AGA suggests AGAINST using thiopurine monotherapy for induction of remission. ( Very Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC in remission, the AGA suggests using thiopurine monotherapy, rather than no treatment, for maintenance of remission, typically induced by corticosteroids. ( Low , Conditional (weak) )
612

In adult outpatients with moderate-to-severe UC, the AGA suggests AGAINST using methotrexate monotherapy, for induction or maintenance of remission.

( Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, the AGA suggests the use of infliximab in combination with an immunomodulator over infliximab or an immunomodulator alone. ( Moderate , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, the AGA suggests the use of adalimumab or golimumab in combination with an immunomodulator over adalimumab, golimumab or immunomodulator monotherapy. ( Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, the AGA makes no recommendation in favor of, or against. the use of non-TNF antagonist biologics in combination with an immunomodulator over non-TNF antagonist biologic alone. ( Evidence Gap , No recommendation )
612
In patients with UC who are in corticosteroid-free clinical remission for at least 6 months on combination therapy of TNF antagonists and an immunomodulator, the AGA makes no recommendation in favor of withdrawing immunomodulators or continuing combination therapy. ( Evidence Gap , No recommendation )
612
In patients with UC who are in corticosteroid-free clinical remission for at least 6 months on combination therapy of TNF antagonists and an immunomodulator, the AGA suggests AGAINST withdrawal of TNF antagonists. ( Very Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, the AGA suggests early use of advanced therapies with or without immunomodulator therapy, rather than gradual step up after failure of 5-ASAs. ( Very Low , Conditional (weak) )
612
In adult outpatients with moderate-to-severe UC, who have failed 5-ASAs, and have escalated to therapy with immunomodulators or advanced therapies, the AGA suggests stopping 5-ASAs. ( Low , Conditional (weak) )
612

Recommendation Grading

Overview

Title

Pharmacological Management of Moderate to Severe Ulcerative Colitis

Authoring Organization

American Gastroenterological Association

Publication Month/Year

November 19, 2024

Last Updated Month/Year

November 21, 2024

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Document Objectives

This document presents the official recommendations of the American Gastroenterological Association (AGA) on the management of moderate to severe ulcerative colitis (UC). This guideline addresses the medical management of adult outpatients with moderate to severe UC, as well as the medical management of adult hospitalized patients with ASUC. The guideline focuses on immunomodulators, biologics, and small molecules for induction and maintenance of remission (for moderate to severe UC) and decreasing the risk of colectomy (for ASUC).

Target Patient Population

Adult outpatients with moderate to severe ulcerative colitis (UC) and adult hospitalized patients with acute severe ulcerative colitis (ASUC)

Inclusion Criteria

Male, Female, Adult

Health Care Settings

Ambulatory, Hospital, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Treatment, Management

Keywords

inflammatory bowel disease, ulcerative colitis, ulcer

Source Citation

Siddharth Singh, Edward V. Loftus, Berkeley N. Limketkai, John P. Haydek, Manasi Agrawal, Frank I. Scott, Ashwin N. Ananthakrishnan, AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis, Gastroenterology, Volume 167, Issue 7, 2024, Pages 1307-1343, ISSN 0016-5085, https://doi.org/10.1053/j.gastro.2024.10.001

Supplemental Methodology Resources

Technical Review