Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis
2024 Clinical Practice Guideline from the American Gastroenterological Association.
Treatment
Advanced Therapies
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 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.
Strong recommendation
Moderate quality evidence
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 the United States, the FDA label recommends use of JAK inhibitors in patients with prior failure or intolerance to TNF antagonist therapy.
Conditional recommendation
Moderate quality evidence
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 the United States, the FDA label recommends use of JAK inhibitors in patients with prior failure or intolerance to TNF antagonist therapy.
Conditional recommendation
Low quality evidence
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).
Conditional recommendation
Low quality evidence
Immunomodulators
In adult outpatients with moderate-to-severe UC, the AGA suggests AGAINST using thiopurine monotherapy for induction of remission.
Conditional recommendation
Very low quality evidence
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.
Conditional recommendation
Low quality evidence
In adult outpatients with moderate-to-severe UC, the AGA suggests AGAINST using methotrexate monotherapy, for induction or maintenance of remission.
Conditional recommendation
Low quality evidence
Combination Therapy
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.
Conditional recommendation
Moderate quality evidence
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.
Conditional recommendation
Low quality evidence
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.
No recommendation
Evidence gap
De-escalation 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 makes no recommendation in favor of withdrawing immunomodulators or continuing combination therapy.
No recommendation
Evidence gap
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.
Conditional recommendation
Very low quality evidence
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.
Conditional recommendation
Low quality evidence
Step Therapy
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.
Conditional recommendation
Very low quality evidence
What do the icons mean?
How strong is the AGA's recommendation?
Strong recommendation
Most individuals in this situation would want the recommended course of action, and only a small proportion would not.Conditional recommendation
The majority of individuals in this situation would want the suggested course of action, but many would not.No recommendation
The confidence in the effect estimate is so low that any effect estimate is speculative at this time.High quality evidence
We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality evidence
We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.Low quality evidence
Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect.Very low quality evidence
We have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.Evidence gap
Available evidence is insufficient to determine true effect.Literature
Original/Primary Reference
