image: New guideline supports early use of high-efficacy therapies over step-up treatment to improve patient outcomes.
Credit: AGA
Bethesda, MD (Nov. 17, 2025) — The American Gastroenterological Association (AGA) has released a comprehensively updated clinical guideline on the pharmacological management of moderate-to-severe Crohn’s disease. The new guideline uses cutting-edge network meta-analyses to recommend prescribing medications based on patients’ prior treatments for moderate-to-severe Crohn’s disease.
The guideline organizes treatments by efficacy to simplify decision-making for gastroenterologists and over 3 million people worldwide living with Crohn’s disease. This living guideline reflects the rapid pace of innovation in medical therapies for Crohn’s disease and provides clinicians with timely, evidence-based guidance to improve patient outcomes. The guideline incorporates new medications and the latest data to support comprehensive, patient-centered care.
“The science in Crohn’s disease is moving quickly, and our goal was to translate that evidence into clear, meaningful recommendations for front-line clinicians,” said guideline author Siddharth Singh, MD, MS. “It’s patient-centered but also provider-centric. We want to help physicians and advanced practice providers make timely, actionable decisions for their patients.”
Key updates
In the guideline, AGA recommends infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, or upadacitinib, and suggests certolizumab pegol or vedolizumab for moderate-to-severe Crohn’s disease.
Importantly, AGA also emphasizes the early use of these advanced therapies compared to step-up approaches using corticosteroids or immunomodulators before these medications.
For patients who have not previously received advanced therapies, preferred options include higher efficacy agents such as infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab, mirikizumab, or guselkumab.
For patients who have previously been treated with advanced therapies, preferred options include higher- or intermediate-efficacy agents such as adalimumab, risankizumab, guselkumab, upadacitinib, ustekinumab, or mirikizumab, over lower-efficacy agents.
Additionally, AGA suggests against using thiopurine monotherapy to induce remission but supports its use over no treatment for maintaining corticosteroid-induced remission.
“These recommendations are about helping patients and providers make informed choices,” Dr. Singh said. “Our goal is to empower shared decision-making and ensure these evidence-based options are accessible and covered by insurance.”
Guideline panel chair and author Frank I. Scott, MD, MSCE, underscored the significance of expanding access to advanced therapies.
“Patients should recognize that there are now multiple treatment options available to them, regardless of where they are in their treatment journey,” Dr. Scott said. “These guidelines highlight those options — and they call for payors to align their formularies with evidence-based medicine.”
The guideline also challenges insurance-driven step therapy, recommending early initiation of high-efficacy medications to prevent disease progression.
“We didn’t write this guideline to follow insurance rules,” Dr. Singh noted. “Insurance coverage should follow the evidence.”
Knowledge gaps and future directions
The guideline panel identified key areas requiring further research, including the use of combination therapy with non-TNF advanced agents and whether targeting endoscopic remission (versus clinical remission) yields additional benefit.
As a living guideline, the authors will conduct semiannual reviews of this body of evidence, and recommendations will be updated when indicated.
Understanding Crohn’s disease
Crohn’s disease causes inflammation (pain and swelling) in the gastrointestinal (GI) tract, also called the digestive system. Inflammation from Crohn’s disease can make it hard to take in nutrients during digestion. Crohn’s disease can have times of remission (when there is no pain or swelling) and relapse (when pain and swelling returns).
While there is no cure for Crohn’s disease, there are treatments that can help.
The most common part of the body affected is the lower part of the small intestine, called the ileum, and the first part of the colon. However, Crohn’s disease can show up in any part of the GI tract, from the mouth to the anus.
Learn more at the AGA GI Patient Center.
See all AGA resources on Crohn’s disease in our provider toolkit.
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AGA Media Contact: Annie Mehl, Communications and Media Relations Manager, media@gastro.org, 301-327-0013
About the AGA Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, AGA represents 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. www.gastro.org
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About Gastroenterology
Gastroenterology is the most prominent journal in the field of gastrointestinal disease. As the official journal of the AGA Institute, Gastroenterology delivers up-to-date and authoritative coverage of both basic and clinical gastroenterology. Regular features include articles by leading authorities and reports on the latest treatments for diseases. Original research is organized by clinical and basic-translational content, as well as by alimentary tract, liver, pancreas, and biliary content. www.gastrojournal.org/
Journal
Gastroenterology
Method of Research
News article
Article Title
AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn’s Disease
Article Publication Date
20-Nov-2025