AGA recommends use of fecal calprotectin, serum CRP to inform Crohn’s disease management

Key takeaways:

• The AGA formulated 11 conditional recommendations to inform the use of biomarkers in the management of Crohn’s disease.
• Recommendations highlight the use of fecal calprotectin and serum C-reactive protein.

Fecal calprotectin and serum C-reactive protein biomarkers can inform disease management for patients with asymptomatic or symptomatic Crohn’s disease, according to an updated clinical practice guideline from the AGA.

“In the CALM (Effect of Tight Control Management on Crohn’s Disease) trial comparing a symptom-based therapeutic strategy with a biomarker-based strategy, the use of frequent biomarker measurement to guide therapy escalation was associated with improved patient outcomes over 2 years,” Ashwin N. Ananthakrishnan, MBBS, MPH, a gastroenterologist at Massachusetts General Hospital and Harvard Medical School, and colleagues wrote in Gastroenterology.

“The performance of serum and fecal biomarkers of disease activity, as well as robust determination of thresholds that can function as surrogates of endoscopic activity assessment, have not been examined comprehensively, leading to significant variability in clinical practice in optimal use of these biomarkers.”

To guide practitioners in the use of these biomarkers for the management of CD, content experts and guideline methodologists participated in a multidisciplinary panel to create patient-focused clinical questions and review evidence on the performance of fecal calprotectin, serum CRP and Endoscopic Healing Index among patients with CD who were asymptomatic, had symptoms of varying severity or were in surgically induced remission.

The guideline also investigated the predictive value of biomarkers for postoperative recurrence.

Highlights of the panel’s 11 conditional recommendations include:

Patients in symptomatic remission

• The AGA recommends a monitoring strategy that combines biomarkers and symptoms, rather than relying on symptoms alone. In patients with confirmation of endoscopic remission, AGA further recommends the use of fecal calprotectin (< 150 µg/g) and/or CRP (< 5 mg/L) to rule out active inflammation.
• The AGA recommends endoscopic evaluation to rule out active inflammation, rather than fecal calprotectin or CRP alone, in patients in symptomatic remission without recent confirmation of endoscopic remission.
• In patients with elevated biomarkers of inflammation, including fecal calprotectin (> 150 µg/g) and CRP (> 5 mg/L), the AGA recommends endoscopic assessment of disease activity rather than empiric treatment adjustment.

Patients with symptomatically active disease

• The AGA recommends biomarker-based assessment and treatment adjustment strategy, rather than relying on symptoms alone.
• In patients with mild symptoms and elevated biomarkers of inflammation (fecal calprotectin > 150 µg/g; CRP > 5 mg/L) or normal biomarkers (< 150 µg/g; CRP < 5 mg/L), the AGA recommends endoscopic assessment of disease activity rather than empiric treatment adjustment.
• In patients with moderate to severe symptoms, the AGA recommends using fecal calprotectin (> 150 µg/g) or CRP (> 5 mg/L) to rule in active inflammation, inform treatment adjustment and avoid routine endoscopic assessment.

Patients in surgically induced remission within past 12 months

• The AGA recommends use of fecal calprotectin (< 50 µg/g) to avoid routine endoscopic assessment of disease activity in asymptomatic patients who are at low risk for postoperative recurrence or who have at least one risk factor for recurrence but are on postoperative pharmacologic prophylaxis.
• The AGA recommends endoscopic evaluation for the assessment of recurrence in asymptomatic patients who are at a high baseline risk for recurrence and are not receiving pharmacologic prophylaxis.

“There has been limited discussion on the role of noninvasive biomarkers in the management of CD in clinical guidelines,” Ananthakrishnan and colleagues wrote. “In patients with clinical response to medical therapy, the guidelines recommended evaluating for mucosal healing either via endoscopy or fecal calprotectin. None of these guidelines discussed performance of specific cutoffs and downstream implications involved in decision-making, which are critical to using these biomarkers in clinical practice.”

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