Evidence-based document guides treatment decisions in patients with moderate to severe UC

AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Bethesda, Maryland (Jan. 21, 2020) — Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) associated with an increased risk of colorectal cancer, can be life-altering for patients with moderate to severe disease activity.

An increasing number of drugs are available for long-term management of moderate to severe UC, leading to questions about treatment strategies for optimal patient care. A new clinical guideline from the American Gastroenterological Association, published in Gastroenterology, the official journal of the AGA Institute, provides recommendations for the management of adult outpatients with moderate to severe UC as well as adult hospitalized patients with acute severe ulcerative colitis (ASUC). The guideline focuses on immunomodulators, biologics, and small molecules to bring on and maintain remission for patients with moderate to severe UC and to decrease the risk of colectomy.

“While there is no cure for ulcerative colitis, currently available therapies can help patients into remission, which means the patient feels well and does not show signs of inflammation. With so many drugs available, the question for many gastroenterologists is what is the right drug for my patient? This guideline takes a comprehensive and evidence-based look at available therapies to provide the most trusted guidance to-date on treatment options to ultimately improve the care of patients with moderate-to-severe UC,” said lead guideline author Joseph D. Feuerstein, MD, Division of Gastroenterology and Center for Inflammatory Bowel Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Here are 5 of the most important guideline recommendations. For all 15 recommendations, review the full guideline.

1. In adult outpatients with moderate to severe UC, AGA recommends using infliximab, adalimumab, golimumab, vedolizumab, tofacitinib or ustekinumab over no treatment. (Strong recommendation: moderate quality evidence)
2. In adult outpatients with moderate to severe UC who are new to biologics, AGA suggests using infliximab or vedolizumab rather than adalimumab for induction of remission. (Conditional recommendation: moderate quality evidence)

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.

1. In adult outpatients with moderate to severe UC who have been exposed to infliximab, particularly those who were not responsive, AGA suggests using ustekinumab or tofacitinib, rather than vedolizumab or adalimumab, for induction of remission. (Conditional recommendation: low quality evidence)

Comment: Patients, particularly those with less severe disease who place higher value on the potential safety of medications, and a lower value on the relative efficacy of medications, may reasonably chose vedolizumab as an alternative.

1. In adult outpatients with moderate to severe UC, AGA suggests early use of biologics with or without immunomodulator therapy, rather than gradual step up after failure of 5-aminosalicylates. (Conditional recommendation: very low quality evidence)

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, may reasonably choose gradual step therapy with 5-ASA therapy.

This recommendation supports AGA’s ongoing fight against step therapy treatment where insurers require patients to try and fail medications before agreeing to cover the initial therapy prescribed by their health care provider. AGA believes that patients should be given a clear, equitable and transparent appeals process when subjected to step therapy protocols. Learn more and take action on this issue.

1. In hospitalized adult patients with acute severe UC refractory to intravenous corticosteroids, AGA suggests using infliximab or cyclosporine. (Conditional recommendation: low quality evidence)

For all 15 recommendations, review the full guideline.

WHAT IS ULCERATIVE COLITIS?

Ulcerative colitis is an inflammatory bowel disease (IBD) that affects the large intestine. In a person with UC, the lining of the colon becomes inflamed and swollen. Untreated UC can lead to problems or other chronic conditions, such as bleeding in the stool, diarrhea, severe dehydration and anemia due to blood loss. UC is associated with an elevated risk of colorectal cancer. Learn more about ulcerative colitis in the AGA GI Patient Center.

Contact for media: Rachel Shubert, [email protected], 301-272-1603

About the AGA Institute

The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. http://www.gastro.org.