Bethesda, MD—New guidelines for ulcerative colitis treatment advocate for more respect for patient preferences, especially when it comes to initiation of a biologic medication.

The American Gastroenterological Association guidelines, published in Gastroenterology, note that the chronic inflammatory bowel disease is associated with an increased risk of colorectal cancer and also can significantly diminish quality of life for patients with moderate-to-severe disease activity.

Guideline authors point out that an increasing number of drugs are available for long-term management of moderate-to-severe UC. Questions remain on optimal treatment strategies for patient care. The new guidelines seek to address that.

Recommendations are for management of adult outpatients with moderate-to-severe UC, as well as adult hospitalized patients with acute severe ulcerative colitis. Included in the guidelines are recommendations on immunomodulators, biologics, and small molecules to foster 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,” explained lead guideline author Joseph D. Feuerstein, MD, of the Division of Gastroenterology and Center for Inflammatory Bowel Diseases at Beth Israel Deaconess Medical Center in Boston.

“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.”

• In adult outpatients with moderate to severe UC, the AGA recommends infliximab, adalimumab, golimumab, vedolizumab, tofacitinib, or ustekinumab over no treatment. That is classified as a strong recommendation with moderate-quality evidence.

• In adult outpatients with moderate to severe UC who are new to biologics, the AGA suggests using infliximab or vedolizumab rather than adalimumab for induction of remission. As to that conditional recommendation with moderate-quality evidence, the authors write, “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.”

• In a conditional recommendation with low-quality evidence, the AGA advises that, in adult outpatients with moderate-to-severe UC who have been exposed to infliximab, particularly those who were not responsive, the AGA suggests using ustekinumab or tofacitinib, rather than vedolizumab or adalimumab, for induction of remission. “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.”

• Early use of biologics with or without immunomodulator therapy is recommended in adult outpatients with moderate-to-severe UC, rather than gradual step-up after failure of 5-aminosalicylates, but the advice is only a conditional recommendation with  low-quality evidence. The authors explain, “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.”

• In hospitalized adult patients with acute severe UC refractory to IV corticosteroids, the AGA suggests using infliximab or cyclosporine in a conditional recommendation with low-quality evidence.

The recommendation on early use of biologics is in line with the AGA’s ongoing battle against step-therapy treatment, where insurers require patients to try and fail medications before agreeing to cover the initial therapy prescribed by their healthcare provider. The association has argued that patients should be given a clear, equitable, and transparent appeals process when subjected to step-therapy protocols.

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