LAS VEGAS – In ulcerative colitis, symptoms aren’t everything. That’s the opinion of Stephen B. Hanauer, MD, medical director of Northwestern University’s Digestive Health Center, Chicago, who discussed the condition and the methods physicians use to assess patient improvement, at the annual meeting of the American College of Gastroenterology.
Many gastroenterologists accept patient reports of symptom improvement, but Dr. Hanauer advocates for a follow-up endoscopy, even when patients are making good progress.
Dr. Stephen Hanauer
Even in patients with improved symptoms, many endoscopic evaluations show inflammation and troubling histology that is in turn associated with worse quality of life and greater odds of hospitalizations and surgery (Dig Liver Dis. 2013 Dec;45:969-77).
So a better outcome is histological healing, characterized by the absence of neutrophils. A study presented at Digestive Disease Week® in 2015 (abstract 592) showed better relapse-free survival after histologic remission. “The deeper the remission that we achieve, the better the outcomes are going to be,” said Dr. Hanauer.
In fact, patients who report that they are asymptomatic may still be experiencing disease. “Many chronic patients accept a certain degree of symptoms as a new normal,” Dr. Hanauer said. Patients accept living with frequent nighttime awakenings to evacuate, or more frequent bowel movements. Further treatment could reduce or eliminate such problems. “There are subtle things you can improve upon, to convince them that the new normal is not the acceptable normal,” said Dr. Hanauer.
He suggests an endoscopy 3-12 months after patients report symptom abatement, although he admits that cost and other considerations can be barriers.
When an endoscopy is performed, it can lead to a conundrum if it shows residual inflammation despite a lack of symptoms. The physician might consider switching to a different class of drug, but that will usually raise cost and introduce new risks of adverse events. “We are doing that in some settings. For example, in postoperative Crohn’s disease, where patients have no active disease, we advocate prophylactically administering agents to prevent recurrence. So we are willing to do that in certain subsets of patients, but we have clinical trials to show the benefits of that,” said Dr. Hanauer. Unfortunately, there are no clinical trials demonstrating the benefits of such an approach in ulcerative colitis.
Biomarkers offer potential assistance for physicians who want to “treat to target,” as Dr. Hanauer put it, to achieve biological remission. Calprotectin – a protein secreted by neutrophils that mark the presence of these cells – are measurable in feces, and the levels correlate well with ulcerative colitis disease activity (Inflamm Bowel Dis. 2012 Nov;18:2011-7).
Dr. Hanauer’s advice to go beyond clinical remission is already occurring at the Food and Drug Administration, which no longer accepts clinical remission findings in testing new drugs for inflammatory bowel disease. “They are requiring patient-reported outcomes accompanied by endoscopic evidence of healing. I’m advocating what’s going on on a regulatory basis be applied on a clinical basis,” said Dr. Hanauer.
Dr. Hanauer had no relevant financial disclosures.
