The American Gastroenterological Association (AGA) released today new evidence-based guidelines for the use of non-invasive testing methods to identify biomarkers, as a first-line strategy for the monitoring and management of ulcerative colitis (UC) in patients both in remission and with active disease.
The updated guidelines, released today in the journal Gastroenterology, details use cases for three different biomarkers that can be used by clinicians to get an accurate read on each patient’s disease activity of UC. Two biomarkers, fecal calprotectin and fecal lactoferrin, can be detected in stool samples and the third, serum C-reactive protein (CRP) can be detected in blood samples.
“For decades we have regarded endoscopy as the gold standard for monitoring ulcerative colitis and detecting bowel inflammation, but repeated endoscopic assessment is invasive, expensive and often impractical,” said Siddarth Singh, MD of the University of California, San Diego and guidelines author. “Not only are biomarkers accurate, but they provide patients with a cheaper and more convenient option of monitoring to ensure medications are working and ultimately keeping their disease well-managed.”
The new guidelines were developed by a multidisciplinary panel of content experts and guideline methodologists’ framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis on the clinical performance of CRP, fecal calprotectin, and fecal lactoferrin as biomarkers of disease activity in patients with established UC in symptomatic remission or with active symptoms. In total, the panel made seven conditional recommendations on the use of these biomarkers in conjunction with a symptom-based monitoring strategy, in order to improve treatments versus a symptom-based strategy alone.
For patients with UC in symptomatic remission, the new guidelines recommend that patients receive biomarker-based monitoring every six to 12 months with an preference for stool testing over blood testing. If biomarker levels are normal, the AGA suggests the continuation of the non-invasive monitoring of patients and not performing invasive endoscopic assessment, but says endoscopic assessment by a gastroenterologist is recommended if testing indicates elevated levels of the biomarkers.
In cases of symptomatically active UC, AGA says biomarker assessment should b the first step to determine whether endoscopy is needed. Patients with mild symptoms and elevated biomarkers should receive endoscopic evaluation by a gastroenterologist; those with moderate to severe symptoms with normal biomarkers should also receive endoscopy; and patients with moderate to severe symptoms who also have elevated biomarkers should receive adjustments in their treatment but avoid endoscopy at that time.
Inflammatory bowel diseases comprising Crohn’s disease and UC are estimated to affect more than seven million people worldwide. UC is characterized by periods of relapsing–remitting activity, resulting in considerable morbidity and as many as one-in-five UC patients undergo definitive surgery in the form of a total colectomy, often for medically refractory disease. The direct and indirect costs attributable to UC are considerable and continue to increase.
Aside from the central goal of improving patient outcomes, the AGA notes that many payers still consider the use of biomarkers as a means of assessing UC to be experimental. The hope is that these new guidelines can help adjust payer policies regarding their use.
“This guideline is a major step in showing the value of noninvasive biomarkers and the importance of insurers covering biomarker monitoring to improve patient satisfaction and clinical outcomes,” noted guideline author Ashwin N. Ananthakrishnan, MD, a gastroenterologist at Massachusetts General Hospital.