Table 4.

Summary of recommendations of the AGA Clinical Guidelines Committee for the Management of Moderate-to-Severe Ulcerative Colitis

Recommendations	Strength of recommendation	Quality of evidence
1. In adult outpatients with moderate-severe ulcerative colitis, the AGA recommends using infliximab, adalimumab, golimumab, vedolizumab, tofacitinib or ustekinumab over no treatment. (Medications are ordered based on year of approval by the US FDA)	Strong	Moderate
2a. In adult outpatients with moderate-severe ulcerative colitis who are naïve to biologic agents, the AGA suggests using infliximab or vedolizumab rather than adalimumab, for induction of remission. Comment: Patients, particularly those with less severe disease, who place higher value on the convenience of self-administered subcutaneous injection, and a lower value on the relative efficacy of medications, may reasonably chose adalimumab as an alternative.	Conditional	Moderate
2b. In adult outpatients with moderate-severe ulcerative colitis who are naïve to biologic agents, the AGA recommends that tofacitinib be only be used in biologic-naive patients in the setting of a clinical or registry study. (No recommendation, knowledge gap) Comment: Updated FDA recommendations (07/26/2019) on indications for use of tofacitinib in ulcerative colitis recommends its use only after failure of, or intolerance to TNFα antagonists.	No recommendation	Knowledge Gap
2c. In adult outpatients with moderate-severe ulcerative colitis who have previously been exposed to infliximab, particularly those with primary non-response, the AGA suggests using ustekinumab or tofacitinib, rather than vedolizumab or adalimumab for induction of remission.	Conditional	Low
3a. In adult outpatients with active moderate-severe ulcerative colitis, the AGA suggests against using thiopurine monotherapy for induction of remission.	Conditional	Very low
3b. In adult outpatients with moderate-severe ulcerative colitis in remission, the AGA suggests using thiopurine monotherapy, rather than no treatment, for maintenance of remission.	Conditional	Low
3c. In adult outpatients with moderate-severe ulcerative colitis, the AGA suggests against using methotrexate monotherapy, for induction or maintenance of remission.	Conditional	Low
4a. In adult outpatients with active moderate-severe ulcerative colitis, the AGA suggests using biologic monotherapy (TNF-α antagonists, vedolizumab or ustekinumab) or tofacitinib rather than thiopurine monotherapy for induction of remission.	Conditional	Low
4b. In adult outpatients with moderate-severe ulcerative colitis in remission, the AGA makes no recommendation in favor of, or against, using biologic monotherapy or tofacitinib, rather than thiopurine monotherapy for maintenance of remission.	No recommendation	Knowledge gap
5a. In adult outpatients with moderate-severe ulcerative colitis, the AGA suggests combining TNFα antagonists, vedolizumab or ustekinumab with thiopurines or methotrexate, rather than biologic monotherapy. Comment: Patients, particularly those with less severe disease, who place higher value on the safety of biologic monotherapy, and lower value on the efficacy of combination therapy, may reasonably chose biologic monotherapy.	Conditional	Low
5b. In adult outpatients with moderate-severe ulcerative colitis, the AGA suggests combining TNF-α antagonists, vedolizumab or ustekinumab with thiopurines or methotrexate rather than thiopurine monotherapy.	Conditional	Low
6. In adult outpatients with moderate-severe ulcerative colitis, the AGA suggests early use of biologic agents with or without immunomodulator therapy, rather than gradual step up after failure of 5-aminosalicylates. Comment: Patients, particularly those with less severe disease, who place higher value on the safety of 5-ASA therapy, and lower value on the efficacy of biologic agents or tofacitinib, may reasonably chose gradual step therapy with 5-ASA therapy.	Conditional	Very low
7. In adult outpatients with moderate-severe ulcerative colitis who have achieved remission with biologic agents and/or immunomodulators or tofacitinib, the AGA suggests against continuing 5-aminosalicylates for induction and maintenance of remission.	Conditional	Very low
8. In hospitalized adult patients with acute severe ulcerative colitis, the AGA suggests using intravenous methylprednisolone dose equivalent of 40 to 60mg/d rather than higher dose intravenous corticosteroids.	Conditional	Very low
9. In hospitalized adult patients with acute severe ulcerative colitis without infections, the AGA suggests against adjunctive antibiotics.	Conditional	Very low
10. In hospitalized adult patients with acute severe ulcerative colitis refractory to intravenous corticosteroids, the AGA suggests using infliximab or cyclosporine.	Conditional	Low
11. In hospitalized adult patients with acute severe ulcerative colitis being treated with infliximab, the AGA makes no recommendation on routine use of intensive vs. standard infliximab dosing.	No recommendation	Knowledge gap

Abbreviations 5-ASA 5-aminosalicylates, AGA American Gastroenterological Association, FDA Food and Drug Administration, TNF tumor necrosis factor, UC ulcerative colitis, US United States