AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis

AGA Clinical Guidelines Committee

doi:10.1053/j.gastro.2022.12.007

AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis

AGA Clinical Guidelines Committee

Medicine - Gastro, Hepatology, Nutrition Division

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

Abstract

Background & Aims: Biomarkers are used frequently for noninvasive monitoring and treatment decision making in the management of patients with ulcerative colitis (UC). This American Gastroenterological Association (AGA) guideline is intended to support practitioners in decisions about the use of biomarkers for the management of UC. Methods: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis on the clinical performance of serum C-reactive protein (CRP), fecal calprotectin, and fecal lactoferrin as biomarkers of disease activity in patients with established UC in symptomatic remission or with active symptoms. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of biomarkers for monitoring and management of UC and provided implementation considerations for clinical practice. Results: The guideline panel made 7 conditional recommendations. In patients with UC in symptomatic remission, the panel suggests the use of a biomarker- and symptom-based monitoring strategy over a symptom-based monitoring strategy. For patients in symptomatic remission, the panel suggests using fecal calprotectin <150 μg/g, normal fecal lactoferrin, and/or normal CRP to rule out active inflammation and avoid routine endoscopic assessment of disease. In patients with UC with moderate to severe symptoms, the panel suggests using fecal calprotectin >150 μg/g, elevated fecal lactoferrin, or elevated CRP to inform treatment decisions and avoid routine endoscopic assessment of disease. However, in patients in symptomatic remission but elevated biomarkers, and in patients with moderate to severe symptoms with normal biomarkers, the panel suggests endoscopic assessment of disease to inform treatment decisions. In patients with UC with mild symptoms, the panel suggests endoscopic assessment of disease activity to inform treatment decisions. The panel identified the use of a biomarker-based monitoring strategy over an endoscopy-based monitoring strategy as a knowledge gap. The panel also proposed key implementation considerations for optimal use of biomarkers, and identified areas for future research. Conclusions: In patients with UC, noninvasive biomarkers, including fecal calprotectin, fecal lactoferrin, and serum CRP can inform disease monitoring and management.

Original language	English (US)
Pages (from-to)	344-372
Number of pages	29
Journal	Gastroenterology
Volume	164
Issue number	3
DOIs	https://doi.org/10.1053/j.gastro.2022.12.007
State	Published - Mar 2023

Bibliographical note

Funding Information:
Funding These guidelines were fully funded by the AGA Institute. Dr Singh is supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants K23DK117058 and R03DK129631. Dr Ananthakrishnan is supported by NIDDK grants R21DK127227 and R01 DK127171, in addition to grants from the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Dr Siddique is supported by NIDDK grant K08DK120902.

Funding Information:
Conflicts of interest These authors disclose the following: Siddharth Singh’s institution has received research grants from Pfizer and AbbVie, and he has received personal fees from Pfizer (for ad hoc grant review). Ashwin N. Ananthakrishnan receives consulting fees from Menten AI and Iterative Scopes. Benjamin L. Cohen receives consulting fees from AbbVie, Celgene-Bristol Myers Squibb, Lilly, Pfizer, Sublimity Therapeutics, Takeda, TARGET RWE; CME Companies: Cornerstones, Vindico; Speaking: AbbVie; Educational Grant: Pfizer. Jeremy Adler received research grants from Janssen Research & Development, LLC. The remaining authors disclose no conflicts. A full list of conflicts active at the time of guideline development can be accessed at AGA’s National Office in Bethesda, MD.

Publisher Copyright:
© 2023 AGA Institute

Keywords

Endoscopic Remission
Evidence Synthesis
Inflammatory Bowel Disease
Monitoring
Treat to Target

PubMed: MeSH publication types

Practice Guideline
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Journal Article

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10.1053/j.gastro.2022.12.007

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title = "AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis",

abstract = "Background & Aims: Biomarkers are used frequently for noninvasive monitoring and treatment decision making in the management of patients with ulcerative colitis (UC). This American Gastroenterological Association (AGA) guideline is intended to support practitioners in decisions about the use of biomarkers for the management of UC. Methods: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis on the clinical performance of serum C-reactive protein (CRP), fecal calprotectin, and fecal lactoferrin as biomarkers of disease activity in patients with established UC in symptomatic remission or with active symptoms. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of biomarkers for monitoring and management of UC and provided implementation considerations for clinical practice. Results: The guideline panel made 7 conditional recommendations. In patients with UC in symptomatic remission, the panel suggests the use of a biomarker- and symptom-based monitoring strategy over a symptom-based monitoring strategy. For patients in symptomatic remission, the panel suggests using fecal calprotectin <150 μg/g, normal fecal lactoferrin, and/or normal CRP to rule out active inflammation and avoid routine endoscopic assessment of disease. In patients with UC with moderate to severe symptoms, the panel suggests using fecal calprotectin >150 μg/g, elevated fecal lactoferrin, or elevated CRP to inform treatment decisions and avoid routine endoscopic assessment of disease. However, in patients in symptomatic remission but elevated biomarkers, and in patients with moderate to severe symptoms with normal biomarkers, the panel suggests endoscopic assessment of disease to inform treatment decisions. In patients with UC with mild symptoms, the panel suggests endoscopic assessment of disease activity to inform treatment decisions. The panel identified the use of a biomarker-based monitoring strategy over an endoscopy-based monitoring strategy as a knowledge gap. The panel also proposed key implementation considerations for optimal use of biomarkers, and identified areas for future research. Conclusions: In patients with UC, noninvasive biomarkers, including fecal calprotectin, fecal lactoferrin, and serum CRP can inform disease monitoring and management.",

keywords = "Endoscopic Remission, Evidence Synthesis, Inflammatory Bowel Disease, Monitoring, Treat to Target",

author = "{AGA Clinical Guidelines Committee} and Siddharth Singh and Ananthakrishnan, {Ashwin N.} and Nguyen, {Nghia H.} and Cohen, {Benjamin L.} and Velayos, {Fernando S.} and Weiss, {Jennifer M.} and Shahnaz Sultan and Siddique, {Shazia M.} and Jeremy Adler and Chachu, {Karen A.}",

note = "Funding Information: Funding These guidelines were fully funded by the AGA Institute. Dr Singh is supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants K23DK117058 and R03DK129631. Dr Ananthakrishnan is supported by NIDDK grants R21DK127227 and R01 DK127171, in addition to grants from the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Dr Siddique is supported by NIDDK grant K08DK120902. Funding Information: Conflicts of interest These authors disclose the following: Siddharth Singh{\textquoteright}s institution has received research grants from Pfizer and AbbVie, and he has received personal fees from Pfizer (for ad hoc grant review). Ashwin N. Ananthakrishnan receives consulting fees from Menten AI and Iterative Scopes. Benjamin L. Cohen receives consulting fees from AbbVie, Celgene-Bristol Myers Squibb, Lilly, Pfizer, Sublimity Therapeutics, Takeda, TARGET RWE; CME Companies: Cornerstones, Vindico; Speaking: AbbVie; Educational Grant: Pfizer. Jeremy Adler received research grants from Janssen Research & Development, LLC. The remaining authors disclose no conflicts. A full list of conflicts active at the time of guideline development can be accessed at AGA{\textquoteright}s National Office in Bethesda, MD. Publisher Copyright: {\textcopyright} 2023 AGA Institute",

year = "2023",

month = mar,

doi = "10.1053/j.gastro.2022.12.007",

language = "English (US)",

volume = "164",

pages = "344--372",

journal = "Gastroenterology",

issn = "0016-5085",

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T1 - AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis

AU - AGA Clinical Guidelines Committee

AU - Singh, Siddharth

AU - Ananthakrishnan, Ashwin N.

AU - Nguyen, Nghia H.

AU - Cohen, Benjamin L.

AU - Velayos, Fernando S.

AU - Weiss, Jennifer M.

AU - Sultan, Shahnaz

AU - Siddique, Shazia M.

AU - Adler, Jeremy

AU - Chachu, Karen A.

N1 - Funding Information: Funding These guidelines were fully funded by the AGA Institute. Dr Singh is supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grants K23DK117058 and R03DK129631. Dr Ananthakrishnan is supported by NIDDK grants R21DK127227 and R01 DK127171, in addition to grants from the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Dr Siddique is supported by NIDDK grant K08DK120902. Funding Information: Conflicts of interest These authors disclose the following: Siddharth Singh’s institution has received research grants from Pfizer and AbbVie, and he has received personal fees from Pfizer (for ad hoc grant review). Ashwin N. Ananthakrishnan receives consulting fees from Menten AI and Iterative Scopes. Benjamin L. Cohen receives consulting fees from AbbVie, Celgene-Bristol Myers Squibb, Lilly, Pfizer, Sublimity Therapeutics, Takeda, TARGET RWE; CME Companies: Cornerstones, Vindico; Speaking: AbbVie; Educational Grant: Pfizer. Jeremy Adler received research grants from Janssen Research & Development, LLC. The remaining authors disclose no conflicts. A full list of conflicts active at the time of guideline development can be accessed at AGA’s National Office in Bethesda, MD. Publisher Copyright: © 2023 AGA Institute

PY - 2023/3

Y1 - 2023/3

N2 - Background & Aims: Biomarkers are used frequently for noninvasive monitoring and treatment decision making in the management of patients with ulcerative colitis (UC). This American Gastroenterological Association (AGA) guideline is intended to support practitioners in decisions about the use of biomarkers for the management of UC. Methods: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis on the clinical performance of serum C-reactive protein (CRP), fecal calprotectin, and fecal lactoferrin as biomarkers of disease activity in patients with established UC in symptomatic remission or with active symptoms. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of biomarkers for monitoring and management of UC and provided implementation considerations for clinical practice. Results: The guideline panel made 7 conditional recommendations. In patients with UC in symptomatic remission, the panel suggests the use of a biomarker- and symptom-based monitoring strategy over a symptom-based monitoring strategy. For patients in symptomatic remission, the panel suggests using fecal calprotectin <150 μg/g, normal fecal lactoferrin, and/or normal CRP to rule out active inflammation and avoid routine endoscopic assessment of disease. In patients with UC with moderate to severe symptoms, the panel suggests using fecal calprotectin >150 μg/g, elevated fecal lactoferrin, or elevated CRP to inform treatment decisions and avoid routine endoscopic assessment of disease. However, in patients in symptomatic remission but elevated biomarkers, and in patients with moderate to severe symptoms with normal biomarkers, the panel suggests endoscopic assessment of disease to inform treatment decisions. In patients with UC with mild symptoms, the panel suggests endoscopic assessment of disease activity to inform treatment decisions. The panel identified the use of a biomarker-based monitoring strategy over an endoscopy-based monitoring strategy as a knowledge gap. The panel also proposed key implementation considerations for optimal use of biomarkers, and identified areas for future research. Conclusions: In patients with UC, noninvasive biomarkers, including fecal calprotectin, fecal lactoferrin, and serum CRP can inform disease monitoring and management.

AB - Background & Aims: Biomarkers are used frequently for noninvasive monitoring and treatment decision making in the management of patients with ulcerative colitis (UC). This American Gastroenterological Association (AGA) guideline is intended to support practitioners in decisions about the use of biomarkers for the management of UC. Methods: A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis on the clinical performance of serum C-reactive protein (CRP), fecal calprotectin, and fecal lactoferrin as biomarkers of disease activity in patients with established UC in symptomatic remission or with active symptoms. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of biomarkers for monitoring and management of UC and provided implementation considerations for clinical practice. Results: The guideline panel made 7 conditional recommendations. In patients with UC in symptomatic remission, the panel suggests the use of a biomarker- and symptom-based monitoring strategy over a symptom-based monitoring strategy. For patients in symptomatic remission, the panel suggests using fecal calprotectin <150 μg/g, normal fecal lactoferrin, and/or normal CRP to rule out active inflammation and avoid routine endoscopic assessment of disease. In patients with UC with moderate to severe symptoms, the panel suggests using fecal calprotectin >150 μg/g, elevated fecal lactoferrin, or elevated CRP to inform treatment decisions and avoid routine endoscopic assessment of disease. However, in patients in symptomatic remission but elevated biomarkers, and in patients with moderate to severe symptoms with normal biomarkers, the panel suggests endoscopic assessment of disease to inform treatment decisions. In patients with UC with mild symptoms, the panel suggests endoscopic assessment of disease activity to inform treatment decisions. The panel identified the use of a biomarker-based monitoring strategy over an endoscopy-based monitoring strategy as a knowledge gap. The panel also proposed key implementation considerations for optimal use of biomarkers, and identified areas for future research. Conclusions: In patients with UC, noninvasive biomarkers, including fecal calprotectin, fecal lactoferrin, and serum CRP can inform disease monitoring and management.

KW - Endoscopic Remission

KW - Evidence Synthesis

KW - Inflammatory Bowel Disease

KW - Monitoring

KW - Treat to Target

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AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

Access

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