AGA updates living guideline on pharmacological management of moderate to severe UC
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Key takeaways:
- The AGA used the GRADE framework to create 14 recommendations for the pharmacological management of moderate to severe UC.
- The living guideline will be updated as new evidence becomes available.
In light of a “significant expansion in the therapeutic armamentarium” for moderate to severe ulcerative colitis, the AGA has released an updated living clinical practice guideline of patient-centered pharmacological interventions.
“In the nearly two decades since the approval of the first biologic therapy (ie, infliximab) for UC in 2005, there have been 11 additional advanced therapies approved for treatment of moderate to severe UC in the United States,” Siddharth Singh, MD, MS, assistant professor of medicine in the division of gastroenterology at the University of California, San Diego, and colleagues wrote in Gastroenterology. “Importantly, seven of these medications, including two novel therapeutic classes, were approved since the publication of the most recent AGA guideline for treatment of moderate to severe UC in 2020.”
The researchers continued, “Thus, the AGA prioritized updating the prior guidelines to provide recommendations for the pharmacological management of moderate to severe UC.”
Singh and colleagues created 12 population-intervention-comparator-outcomes questions, conducted an evidence synthesis and developed 14 recommendations, based on the Grading of Recommendations, Assessment, Development and Evaluation framework. They also considered each intervention’s benefit vs. harm profile; patient values and preferences; feasibility, acceptability and resource requirements; and impact on health equity. The experts used “recommend” and “suggest” to indicate strong and conditional recommendations, respectively.
Highlights of the living guideline, which will be updated as new evidence becomes available, include:
- The AGA recommends use of infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab and guselkumab over no treatment and suggests use of adalimumab, filgotinib or mirikizumab over no treatment for outpatients with moderate to severe UC.
- The AGA suggests use of higher or intermediate efficacy medications over those with lower efficacy for outpatients naive to advanced therapies or with previous exposure to at least one advanced therapies.
- The AGA suggests against the use of thiopurine monotherapy or methotrexate monotherapy for induction or maintenance of remission.
- The AGA suggests use of infliximab in combination with an immunomodulator vs. infliximab or an immunomodulator alone. Similarly, the AGA suggests use of adalimumab or golimumab in combination with an immunomodulator over either treatment or an immunomodulator alone.
- The AGA suggests against tumor necrosis factor antagonist withdrawal among patients who achieved corticosteroid-free remission for 6 months or more with TNF antagonists in combination with an immunomodulator.
- The AGA suggests that patients who have failed 5-aminosalicylic acids (5-ASAs) and escalated to immunomodulators or advanced therapies should stop 5-ASAs.
- The AGA suggests early use of advanced therapies, with or without immunomodulators, over gradual step up following 5-ASA failure.
“Recognizing the rapid evolution of drug development and transforming treatment strategies, the AGA will update relevant recommendations from these guidelines by periodic review of evidence every 6 months,” Singh and colleagues wrote. “The evidence reviewed will include availability of phase 3 or phase 4 efficacy data for new treatments, treatment strategies or existing treatments as well as significant new safety concerns informing treatment positioning.”
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