American Gastroenterological Association releases new Crohn’s disease clinical practice guidelines

The American Gastroenterological Association (AGA) has released a new clinical guideline for treating moderate to severe Crohn’s disease in the adult outpatient setting, according to a news release published today. The 16 recommendations are listed in order of effectiveness to simplify the decision-making process. The guidelines were published in Gastroenterology.

A panel of 10 experts developed the guidelines using data from updated trials. Evidence was translated into recommendations during panel discussions over several meetings.

“Since the last version of the guidelines published in 2021, four new medications have been approved for the treatment of CD, nearly doubling the number of treatment options since the last guideline,” Siddharth Singh, M.D., Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Arizona, and guideline co-author, said in an email interview with Managed Healthcare Executive.

The guideline classifies patients with moderate-to-severe Crohn’s disease as having:

• moderate-to-severe abdominal pain
• mild symptoms with high levels of inflammation
• corticosteroid dependence
• upper gastrointestinal tract involvement

Crohn’s disease, a type of chronic inflammatory bowel disease, affects more than 1 million Americans, according to the guideline. The disease is characterized by abdominal cramps, weight loss, fever and diarrhea. Disease severity can vary over time because it can occur at different points along the digestive tract. Complications include fistulas, which are ulcers on the wall of the intestine that connect to other parts of the digestive tract; abscesses; and strictures, which are the narrowing of the intestine caused by scarring.

Treatment for Crohn’s disease includes medication, lifestyle modifications and surgery. Medication is used to reduce the inflammation, allowing the digestive tract to heal and diet changes, such as the elimination of dairy and spicy foods, can also ease inflammation. However, approximately 70% of Crohn’s disease patients eventually require surgery to remove parts of the infected bowel, drain abscesses or remove fistulas.

“Most available medications for treating Crohn’s disease are approved for moderate-to-severe Crohn’s disease,” Singh said. “Mild Crohn’s disease is hard to define, difficult to prognosticate and doesn't likely warrant aggressive immunosuppressive therapy. There have been very few trials in patients with mild Crohn’s disease. Hence, we opted to focus on moderate-to-severe Crohn’s disease, where there is a much higher risk of developing complications.”

The recommendations are organized by disease severity, with importance placed on trying advanced therapies first, rather than trying step-up approaches that rely on corticosteroids, which can cause dependence, or immunomodulators, which can take months to work.

For all patients, the panel strongly recommends any of the following over no treatment: infliximab, adalimumab, ustekinumab, risankizumab, guselkumab and upadacitinib.

The panel only suggests the use of certolizumab pegol and vedolizumab over no treatment.

Specifically, for patients new to advanced therapies, the guideline recommends infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab or guselkumab. For patients who have been treated previously with advanced therapies, the guidelines recommend adalimumab, risankizumab, guselkumab, upadacitinib, ustekinumab or mirikizumab, which are higher- or intermediate-efficacy medications.

“These are living guidelines, meaning the evidence informing different questions within the guideline will be reviewed every 6 months,” Singh said. “If there is meaningful new information based on updated evidence, then we will issue updated recommendations. The field is moving very fast, with several advances in drug development, positioning of agents, and different treatment strategies, so it is important to stay updated.”