Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis

In adult outpatients with moderate-to-severe ulcerative colitis (UC), the AGA recommends the use of infliximab, golimumab, vedolizumab, tofacitinib*, upadacitinib*, ustekinumab, ozanimod, etrasimod, risankizumab and guselkumab over no treatment.

*In the United States, the FDA label recommends use of Janus Kinase (JAK) inhibitors in patients with prior failure or intolerance to Tumor Necrosis Factor (TNF) antagonist therapy.

In adult outpatients with moderate-to-severe UC, the AGA suggests the use of adalimumab, filgotinib* or mirikizumab over no treatment.

*In the United States, the FDA label recommends use of JAK inhibitors in patients with prior failure or intolerance to TNF antagonist therapy.

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).

*In the United States, the FDA label recommends use of JAK inhibitors in patients with prior failure or intolerance to TNF antagonist therapy.

In adult outpatients with moderate-to-severe UC who have previously been exposed to 1 or more advanced therapies, particularly TNF antagonists, the AGA suggests using a HIGHER efficacy medication (tofacitinib, upadacitinib, ustekinumab) OR an INTERMEDIATE efficacy medication (filgotinib, mirikizumab, risankizumab, guselkumab), rather than a LOWER efficacy medication (adalimumab, vedolizumab, ozanimod, etrasimod).

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

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.

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

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.

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.

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 biologic alone.

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.

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.

In adult outpatients with moderate-to-severe UC, who have failed 5-aminosalicylic acids (5-ASAs), and have escalated to therapy with immunomodulators or advanced therapies, the AGA suggests stopping 5-ASAs.

In adult outpatients with moderate-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.