The American Gastroenterological Association (AGA) has released a new clinical practice guideline defining the role of biomarkers in monitoring and managing ulcerative colitis (UC).
Long-term data remain insufficient to recommend the use of a biomarker-based treat-to-target strategy over endoscopy-based monitoring; however, in many cases, biomarkers should be considered before pursuing endoscopy or treatment adjustments, reported lead guideline panelist Siddharth Singh, MD, of University of California San Diego, La Jolla, Calif., and colleagues.
“[I]n routine clinical practice, repeated endoscopic assessment is invasive, expensive, and may be impractical,” the panelists wrote. Their report is in Gastroenterology. “There is an important need for understanding how noninvasive biomarkers may serve as accurate and reliable surrogates for endoscopic assessment of inflammation and whether they can be more readily implemented in a UC care pathway.”
After reviewing relevant randomized controlled trials and observational studies, Dr. Singh and colleagues issued seven conditional recommendations, three of which concern patients in symptomatic remission, and four of which apply to patients with symptomatically active UC.
“The key take-home message is that the routine measurement of noninvasive biomarkers in addition to assessment of patient reported symptoms is critical in evaluating the disease burden of UC,” said Jordan E. Axelrad, MD, MPH, director of clinical and translational research at NYU Langone Health’s Inflammatory Bowel Disease Center, New York. “Many of these recommendations regarding the assessment of disease activity beyond symptoms alone are widely accepted, particularity at tertiary IBD centers; however, this guideline serves to formalize and structure the recommendations, with appropriate test cutoff values, in a simple UC care pathway.”
Recommendations for patients in symptomatic remission
For patients in remission, the guideline advises monitoring both symptoms and biomarkers, with biomarkers measured every 6-12 months.
Asymptomatic patients with normal biomarkers can skip routine endoscopy, according to the guideline, but those with abnormal fecal calprotectin, fecal lactoferrin, or serum C-reactive protein (CRP) are candidates for endoscopic assessment instead of empiric treatment adjustment.
“The most important pearl [from the guideline] is that fecal calprotectin less than 150 mcg/g, normal fecal lactoferrin, or normal CRP, can be used to rule out active inflammation in patients in symptomatic remission,” according to Dr. Axelrad.
The guideline suggests that the two fecal biomarkers “may be optimal for monitoring and may be particularly useful in patients where biomarkers have historically correlated with endoscopic disease activity.” In contrast, normal CRP may be insufficient to rule out moderate to severe endoscopic inflammation in patients who recently entered remission following treatment adjustment.
While abnormal biomarkers in asymptomatic patients are sufficient cause for endoscopy, the guideline also suggests that retesting in 3-6 months is a reasonable alternative. If biomarkers are again elevated, then endoscopic evaluation should be considered.
Recommendations for patients with symptomatically active disease
The recommendations for patients with symptomatically active UC follow a similar pathway. The guideline advises an evaluation strategy combining symptoms and biomarkers instead of symptoms alone.
For example, patients with moderate to severe symptoms suggestive of flare and elevated biomarkers are candidates for treatment adjustment without endoscopy.
Still, patient preferences should be considered, Dr. Singh and colleagues noted.
“Patients who place greater value in confirming inflammation, particularly when making significant treatment decisions (such as starting or switching immunosuppressive therapies), and lesser value on the inconvenience of endoscopy, may choose to pursue endoscopic evaluation before treatment adjustment,” they wrote.
For patients with mild symptoms, endoscopy is generally recommended, according to the guideline, unless the patient recently had moderate to severe symptoms and has improved after treatment adjustment; in that case, biomarkers can be used to fine-tune therapy without the need for endoscopy.
Again, providers should engage in shared-decision making, the guideline advises. Patients with mild symptoms but no biomarker results may reasonably elect to undergo endoscopy prior to testing biomarkers, while patients with mild symptoms and normal biomarkers may reasonably elect to retest biomarkers in 3-6 months.
Data remain insufficient to recommend biomarkers over endoscopy
Dr. Singh and colleagues concluded the guideline by highlighting an insufficient level of direct evidence necessary to recommend a biomarker-based treat-to-target strategy over endoscopy-based monitoring strategy, despite indirect evidence suggesting this may be the case.
“[T]here have not been any studies comparing a biomarker-based strategy with an endoscopy-based strategy for assessment and monitoring of endoscopic remission,” they wrote. “This was identified as a knowledge gap by the panel.”
The authors disclosed relationships with Pfizer, AbbVie, Lilly, and others. Dr. Axelrad disclosed relationships with Janssen, AbbVie, Pfizer, and others.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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