In December 2024, the American Gastroenterological Association (AGA) published an updated clinical guideline for the pharmacological management of moderate-to-severe ulcerative colitis (UC) in gastroenterology. The new ‘living’ guideline marks a major shift away from the traditional step-up approach, recommending early use of advanced therapies such as biologics and small molecules after 5-aminosalicylic acid failure. The guideline reflects a growing consensus that prompt initiation of more effective treatments improves remission rates, reduces corticosteroid exposure, and minimises long-term complications.
Among the ten therapies receiving strong recommendations are established agents such as Janssen’s Remicade (infliximab) and Takeda’s Entyvio (vedolizumab), as well as newly approved options such as AbbVie’s Rinvoq and Skyrizi, Pfizer’s Velsipity, and Janssen’s Tremfya. For biologic-naive patients, high-efficacy options such as these are now preferred. In patients with prior tumour necrosis factor exposure, therapies with alternative mechanisms such as Janus kinase inhibitors (Rinvoq, Pfizer’s Xeljanz), and Janssen’s anti-interleukin-12/23, Stelara (ustekinumab), are recommended over other agents. Meanwhile, AbbVie’s Humira (adalimumab), once a frontline UC treatment, is now considered lower efficacy and carries only a conditional recommendation.
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These updates will likely reshape both clinical behaviour and market dynamics. AbbVie is especially well-positioned, with Rinvoq and Skyrizi gaining traction just as Humira’s role diminishes. Pfizer’s Velsipity benefits from its strong endorsement as a first-line option while Janssen’s Tremfya joins the therapeutic mix alongside legacy infliximab. Takeda’s Entyvio remains prominent due to its favourable efficacy and safety profile. Biosimilars of infliximab, adalimumab, and ustekinumab are endorsed as interchangeable, and subcutaneous formulations of infliximab and vedolizumab are now supported for maintenance therapy.
The guideline may also pressure payers to reassess step therapy policies that have historically delayed access to newer, more effective drugs. With AGA emphasising comparative efficacy, coverage decisions will increasingly need to align with clinical evidence rather than cost alone. As the first living UC guideline, this framework will be updated semiannually, reinforcing an agile and evidence-driven approach to inflammatory bowel disease care. For manufacturers, payers, and providers alike, the message is clear: treatment algorithms will increasingly reward innovation, speed, and performance in the real world.
