This protocol covers adult outpatients with moderate-to-severe ulcerative colitis who have already received one or more advanced therapies — particularly TNF antagonists — and require a structured, evidence-based approach to selecting the next medication.
Moderate-to-severe ulcerative colitis in an adult outpatient; prior exposure to one or more advanced therapies, particularly TNF antagonists. Medication selection in this population must account for that prior treatment history.
Symptomatic response within 3 months of initiation; symptomatic and biochemical remission within 3–6 months (clinical remission defined as Mayo Clinic score <3, with no individual subscore >1); endoscopic improvement or remission within 6–12 months.
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).
While there is no direct RCT evidence, observational studies demonstrate that infliximab and golimumab are effective in inducing remission in patients with prior exposure to advanced therapies.
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.
Scores of 6–12 correspond to moderate-to-severe disease activity, whereas clinical remission is most consistently defined as Mayo Clinic score <3, with no individual subscore >1.
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