AGA Releases New Ulcerative Colitis Guidance

April 22, 2020
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

New guidelines suggest patients with moderate to severe ulcerative colitis should be treated with infliximab, tofacitinib, and ustekinumab.

Joseph D. Feuerstein, MD

A new set of recommendations for patients with ulcerative colitis (UC) includes a variety of treatment options suitable to treat the disease.

A team, led by Joseph D. Feuerstein, MD, Division of Gastroenterology and Center for Inflammatory Bowel Diseases at Beth Israel Deaconess Medical Center, recently released new ulcerative colitis guidelines on behalf of the American Gastroenterology Association (AGA) that address the adult outpatients with moderate to severe ulcerative colitis, as well as the medical management of adult hospitalized patients.

The guideline focuses on immunomodulators, biologics, and small molecules for induction and maintenance of remission for moderate to severe ulcerative colitis and decreasing the risk of colectomy patients with acute severe ulcerative colitis.

The authors strongly suggest adult outpatients with moderate to severe UC, the AGA recommends using infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, or ustekinumab over no treatment.

Also, adult outpatients with moderate to severe ulcerative colitis who are naïve to biologic agents should use infliximab or vedolizumab rather than adalimumab, for induction of remission and tofacitinib should only be used in the setting of a clinical or registry study.

For adult outpatients who were previously exposed to infliximab, especially with hose with primary nonresponse, the AGA suggests using ustekinumab or tofacitinib rather than vedolizumab or adalimumab for induction of remission.

In adult outpatients with active moderate to severe disease, the AGA suggests against using thiopurine monotherapy for induction of remission and methotrexate monotherapy for induction or maintenance of remission.

“The panel recommends treating adult outpatients with moderate to severe UC with infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, or ustekinumab over no treatment for the induction and maintenance of remission,” the authors wrote.

The authors focused on 16 randomized controlled trials comparing TNF-α antagonists, vedolizumab, tofacitinib, and ustekinumab to placebo.

All active interventions were superior to placebo for induction of remission, regardless of prior biologic exposure (infliximab: RR, 2.85; 95% CI, 2.11—3.86; adalimumab: RR, 1.62; 95% CI, 1.15–2.29; golimumab: RR, 2.49; 95% CI, 1.58–3.93; vedolizumab: RR, 2.22; 95% CI, 1.36–3.64; tofacitinib: RR, 3.22; 95% CI, 2.03–5.08; and ustekinumab: RR, 2.91; 95% CI, 1.72–4.94).

All active interventions were superior to placebo for maintenance of remission (infliximab: RR, 2.25; 95% CI, 1.67—3.05; adalimumab: RR, 2.28; 95% CI, 1.52–3.42; golimumab: RR, 1.88; 95% CI, 1.32–2.68; vedolizumab: RR, 2.31; 95% CI, 1.63–3.28; tofacitinib 5 mg twice daily: RR, 3.09; 95% CI, 1.99–4.79; and ustekinumab: RR, 1.83; 95% CI, 1.33–2.49).

Based on population-based cohort studies, most patients with ulcerative colitis have a mild to moderate course that is usually most active at diagnosis and then in varying periods of remission or mild activity. About 15% patients experience an aggressive course, with 20% of this patient population require hospitalization for severe disease activity.

There are severely different drug classes for long-term management of moderate to severe ulcerative colitis, including TNF-α antagonists, anti-integrin agent (vedolizumab), Janus kinase inhibitor (tofacitinib), interleukin 12/23 antagonist (ustekinumab), and immunomodulators (thiopurines, methotrexate).

The majority of these treatments are initiated for induction of remission and are continued as maintenance therapy if they are effective. This practice is considered the standard of care by the guidelines and it is assumed that if a drug—other than corticosteroids and cyclosporine—is started for and is effective for induction of remission or response will be continued for maintenance of remission.

Ulcerative colitis peaks in early adulthood and if left untreated can relapse and remit mucosal inflammation.

The new guidelines were developed by the AGA Institute’s Clinical Guidelines Committee and approved by the AGA Governing Board.

The study, “AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis,” was published online in Gastroenterology.