Role of Biomarkers for the Management of Crohn’s Disease
Patients with CD in symptomatic remission
Recommendation 1
In patients with CD in symptomatic remission, the AGA suggests a monitoring strategy that combines biomarkers and symptoms, rather than relying on symptoms alone.
( Low , Conditional (weak) )Comment: Patients who place a higher value on avoiding the burden of biomarker testing, over a potentially higher risk of flare and disease progression caused by missing subclinical inflammation, may reasonably choose interval symptom-based monitoring.
Implementation considerations:
Interval biomarker monitoring may be performed every 6–12 mo in patients in symptomatic remission.
Biomarker-based monitoring may be particularly useful in patients w biomarkers have historically correlated with endoscopic disease activity
Recommendation 2
In patients with CD in symptomatic remission with recent confirmation of endoscopic remission (without any change in clinical status, on stable therapy), the AGA suggests using fecal calprotectin <150 μg/g and/or CRP <5 mg/L (or below cutoff for normal range for the laboratory) to rule out active inflammation, and avoid routine endoscopic assessment of disease activity.
(Low to Moderate, Conditional (weak) )Recommendation 3
- The panel considered recent confirmation of endoscopic or radiologic remission to ideally have been within 3 y.
- Radiologic assessment of disease activity may be a reasonable alternative to endoscopic assessment for patients with predominantly small bowel involvement.
Recommendation 4
In patients with CD in symptomatic remission, with elevated biomarkers of inflammation (fecal calprotectin >150 μg/g, CRP >5 mg/L), the AGA suggests endoscopic assessment of disease activity rather than empiric treatment adjustment.
( Low , Conditional (weak) )Implementation considerations:
- In patients with CD in sustained symptomatic remission but elevated biomarkers, repeat measurement of biomarkers (in 3–6 mo) may be a reasonable alternative to endoscopic (or radiologic) assessment, especially if the latter has been performed recently.
- Lack of normalization of biomarkers (or persistently elevated biomarkers) in patients whose symptoms recently resolved after initial treatment of symptomatically active CD, likely suggests active inflammation, and may warrant treatment adjustment, without need for endoscopic (or radiologic) evaluation.
Patients with symptomatically active CD
Recommendation 5
Implementation considerations:
- Interval biomarker assessment and treatment adjustment may be performed every 2–4 mo in patients being treated for active symptoms.
- After resolution of symptoms (and normalization of biomarkers), endoscopic (and/or radiologic) evaluation should be performed to rule out active inflammation, typically 6–12 mo after treatment initiation or adjustment. The patient may then transition to guidance for patients in symptomatic remission.
Recommendation 6
- Lack of normalization of biomarkers (or persistently elevated biomarkers) in patients whose symptoms partially improve after initial treatment of active CD, likely suggests active inflammation, and may warrant treatment adjustment, without need for endoscopic (or radiologic) evaluation.
Recommendation 7
In patients with CD with mild symptoms and normal biomarkers of inflammation (fecal calprotectin <150 μg/g, CRP <5 mg/L), the AGA suggests endoscopic assessment of disease activity rather than empiric treatment adjustment.
( Very Low , Conditional (weak) )Recommendation 8
Recommendation 9
In patients with CD with moderate to severe symptoms with normal biomarkers of inflammation (fecal calprotectin <150 μg/g, CRP <5 mg/L), the AGA suggests endoscopic assessment of disease activity rather than empiric treatment adjustment.
( Low , Conditional (weak) )Patients with CD in surgically induced remission
Recommendation 10
Recommendation 11
In asymptomatic patients with CD after surgically induced remission within the past 12 months, who are at high baseline risk of recurrence and are not receiving postoperative pharmacologic prophylaxis, the AGA suggests endoscopic evaluation, rather than relying solely on biomarkers, for assessing endoscopic recurrence.
(Low to Moderate, Conditional (weak) )Implementation considerations:
- Risk stratification schemes to classify patients’ risk of endoscopic recurrence after surgically induced remission are not well-defined. Risks factors typically associated with low risk of recurrence 6–12 mo after surgically induced remission include older age at surgery (older than 50 y), nonsmoking, long-standing disease (more than 10 y), and first surgery for a short segment of fibrostenotic disease (<10–20 cm). Risk factors typically associated with high risk of recurrence 6–12 mo after surgically-induced remission include two or more prior surgeries, penetrating or perianal disease, smoking, young age at surgery, with long segment of small bowel resection. However, these risk factors may not be additive.
- In patients at low baseline risk of recurrence, who are also receiving postoperative pharmacologic prophylaxis, fecal calprotectin <150 µg/g may also rule out endoscopic recurrence.
- Normal CRP in patients with asymptomatic CD in surgically induced remission is not able to rule out endoscopic recurrence accurately.
- There are limited data on ongoing biomarker monitoring alone in patients with CD in surgically induced remission. Colonoscopic evaluation may be warranted beyond 12 mo after surgery in patients when biomarker-based monitoring is being pursued.
Endoscopic Healing Index (EHI) (Monitr) in Patients With CD
Recommendation 12
Biomarker- vs Endoscopy-based Monitoring Strategy in Patients With CD
Recommendation Grading
Abbreviations
- AGA: American Gastroenterological Association
- CD: Crohn's Disease
- CRP: C-reactive Protein
- EHI: Endoscopic Healing Index
- IBD: Inflammatory Bowel Disease
Disclaimer
Overview
Title
Role of Biomarkers for the Management of Crohn’s Disease
Authoring Organization
American Gastroenterological Association
Publication Month/Year
November 15, 2023
Last Updated Month/Year
October 3, 2024
Supplemental Implementation Tools
Document Type
Guideline
Country of Publication
US
Document Objectives
The objective of this guideline was to inform the role of commonly used serum and fecal biomarkers as surrogates for endoscopic disease activity for both cross-sectional assessment and longitudinal monitoring of patients with an established diagnosis of CD.
Target Patient Population
Patients with Crohn's Disease (CD)
Target Provider Population
Gastroenterology health care professionals; primary care, emergency, and urgent care providers; patients; and policy makers
PICO Questions
In patients with CD in symptomatic remission, is interval biomarker-based monitoring superior to symptom-based monitoring to improve long-term outcomes?
In patients with CD in symptomatic remission, at what fecal calprotectin, serum CRP, and EHI cutoff can we accurately rule out active inflammation, obviating routine endoscopic assessment?
In patients with symptomatically active CD, is an evaluation strategy that combines biomarkers and symptoms superior to symptom-based evaluation for making treatment adjustments?
In patients with symptomatically active CD, at what fecal calprotectin, serum CRP, and EHI cutoffs can we accurately diagnose active inflammation, obviating routine endoscopic assessment?
In patients with CD in surgically induced remission, at what fecal calprotectin, serum CRP, and EHI cutoffs can we accurately rule out postoperative endoscopic recurrence, obviating routine endoscopic assessment?
In patients with established CD, is interval biomarker-based monitoring strategy superior to interval endoscopy-based monitoring strategy to improve long-term outcomes?
Inclusion Criteria
Male, Female, Adolescent, Adult, Child, Older adult
Health Care Settings
Ambulatory, Laboratory services
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Assessment and screening
Diseases/Conditions (MeSH)
D003424 - Crohn Disease
Keywords
biomarkers, Crohn's disease, IBD, CD, crohns disease