An updated clinical guideline on the management of ulcerative colitis (UC) shifts the focus from symptom-based treatment to both symptom management and mucosal healing.
The guideline was prepared by David T. Rubin, MD, FACG, from the University of Chicago, Illinois, and colleagues on behalf of the American College of Gastroenterology (ACG). It was published online February 27 in the American Journal of Gastroenterology.
“Since our 2010 set of guidelines, we’ve subsequently had multiple new therapies for UC approved by the Food and Drug Administration, and we’ve moved our entire goal of management from symptom-based treatment to treatment based on both symptoms and the objective control of inflammation by showing that the mucosa of the colon have healed,” Rubin told Medscape Medical News. “If you can achieve this, you also reduce the likelihood of relapse.”
Rubin is Joseph B. Kirsner Professor of Medicine at the University of Chicago and chief of gastroenterology, hepatology, and nutrition and codirector of the Digestive Diseases Center at the University of Chicago Medicine.
Covering all aspects of UC from diagnosis and medical management to quality of life, the user-friendly recommendations offer practicing clinicians “a one-stop shopping experience for updated information,” said coauthor Millie D. Long, MD, MPH, FACG, an associate professor of medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina in Chapel Hill, in an ACG podcast.
In addition to the emphasis on bowel healing to reduce both symptoms and relapse risk, another major — possibly controversial — shift is the important separation between disease activity and disease severity. “These used to be lumped together for treatment,” Rubin said. He noted that disease activity refers to how sick the patient is at evaluation, whereas severity reflects the patient’s prognosis and complicated outcomes, such as the need for surgery.
“A patient can be in remission and feeling well, but the disease burden can be more severe, owing to more extensive colitis, a younger age at diagnosis, previous hospitalization, or Clostridium difficile infection, which puts them at higher risk,” he said.
The new guideline emphasizes choosing severity-based maintenance therapies for moderate to severe UC in order to lower the chance of future complications. “Rather than waiting for patients to become sick, we are now using those therapies before patients experience complications,” said Rubin. “We are finally getting ahead of the disease instead of always chasing it.”
Rubin also pointed to new biologic therapies that are addressed in the guidelines. These include several antitumor necrosis factor agents, the anti-integrin antibody vedolizumab (Entyvio, Takeda), and tofacitinib (Xeljanz, PF Prism CV), a small-molecule oral inhibitor of janus kinase.
The guideline also aims to help physicians persuade payers to cover the stool test for calprotectin, a useful proxy for active inflammation and response to therapy and a predictor of relapse. “Payers keep saying this test is experimental, but in the guidelines we embrace it as an option that is much less expense than scoping. We provide our colleagues with support so that payers will cover it,” Rubin said.
In sum, he said, the guidelines reflect how UC management is moving toward the type of monitoring established for diabetes. “The general principle is monitoring disease before the patient gets sick or ends up in hospital or having surgery,” Rubin added. “We’ve had tremendous advances in the management of UC, and we’ve moved from being reactive to being much more proactive to achieve sustained, stable remission and minimize complications.”
Among specific changes highlighted by Long in the podcast is an evidence-based approach to diagnosis. For instance, the authors strongly recommend stool testing to rule out C difficile infection in suspected cases of UC. On the basis of the evidence, the authors also strongly discourage the use of serologic antibody panels to establish or exclude UC or determine disease prognosis.
In addition, disease severity should be determined not only on the basis of the classic indices of bleeding and diarrhea but also on multiple other factors, including inflammatory burden, previous treatment failure or hospitalization, and impact on patient functionality and quality of life. “If we take these factors into account, perhaps we will put the patient in the right bucket of medication,” Long said.
In another strong recommendation, the authors advocate the use of combination oral and topical therapy for left-sided UC. “The evidence shows that 5-ASA [aminosalicylates] in enemas, suppositories, and oral doses are more effective than oral treatment alone,” Long said.
No funding was provided. Several authors report financial relationships with companies, including Above, Abgenomics, Allergen, Furring, Genetic/Roche, Janssen, Merck, Medtronic, Napa Pharmaceuticals, Pfizer, Shire, Takeda, Target Parma Solutions, Lilley, Amgen, Carlene, Santos, Prometheus, Sebeka, UCB, and Heritance.
Am J Gastroenterology. Published online February 27, 2019. Abstract