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Updated ACG UC Guidelines Provide ‘Practical’ Management Approach
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The American College of Gastroenterology has released updated guidelines on the diagnosis and management of patients with mildly and moderately to severely active ulcerative colitis.
The guidelines also address the prevention of colorectal cancer in patients with ulcerative colitis, as well as patients hospitalized with the disease.
“The guidelines are supposed to guide practitioners and to propel the field forward in accepting and incorporating new therapies and new approaches in our management, and they are also importantly supposed to support our providers and patients so that payers will acknowledge and approve different treatment strategies,” David T. Rubin, MD, FACG, section chief of gastroenterology, hepatology and nutrition, and co-director of the Digestive Diseases Center at the University of Chicago Medicine, and lead author of the guidelines, told Healio Gastroenterology and Liver Disease.
There was a clear need, according to Rubin, for an update as there has been a significant amount of change since the last set of guidelines were published by the ACG in 2010.
“There are multiple therapies that have been approved by the FDA for the treatment of ulcerative colitis and there are a variety of other changes in the field that we have acknowledged,” Rubin said. “The new guidelines offer substantial updates to the way we should evaluate and treat patients who have ulcerative colitis.”
Millie D. Long, MD, MPH, FACG, an associate professor of medicine in the division of gastroenterology and hepatology at the University of North Carolina, and a co-author of the guidelines, agreed that it was time for an update.
“The deciding factor in undertaking development of these guidelines was significant changes in the field of ulcerative colitis management since the publication of prior guidelines,” Long wrote in an email to Healio Gastroenterology and Liver Disease. “The gastroenterology community needed updated guidelines on all aspects of UC management, from diagnosis, to definitions of disease severity, to therapeutic medical management of the outpatient, to inpatient management to recommendations for dysplasia surveillance.”
The updated guidelines include 49 recommendations based on GRADE criteria, and 54 summary statements.
Important guidelines updates
One of the main highlights to come from the updated guidelines, according to Rubin, was the separation of disease activity and severity.
“Recognizing that the choice of therapies for patients is not only about how sick they are at the time their disease may be active, but also what their prognosis is,” he said. “You can choose therapies based on prognosis even in somebody who may have a milder disease. In consideration of this, we also developed a new disease activity index. The ACG disease activity index for the first time includes urgency as a symptom, which has not been included before, but is obviously a significant symptom in people with ulcerative colitis and it includes endoscopic activity as a component of it, as well as fecal calprotectin.”
Additionally, Rubin said a new and important focus of the guidelines was its emphasis on the new therapies that are now available.
For instance, since the last set of guidelines were released in 2010, according to Rubin, golimumab (Simponi, Janssen), vedolizumab (Entyvio, Takeda) and tofacitinib (Xeljanz, Pfizer) have all been introduced to the armamentarium to treat UC.
“The guidelines now incorporate those therapies for our patients and review the evidence and support using those in appropriate patients,” he said.
Anti-TNF therapies such as golimumab, adalimumab (Humira, AbbVie) and infliximab (Remicade, Janssen) received a strong recommendation in patients with moderately to severely active UC for induction and maintenance of remission.
Tofacitinib and vedolizumab for induction and maintenance of remission received strong recommendations to be used in patients with moderately to severely active UC.
Understanding therapies
Rubin also acknowledged that he thinks it is very important that the guidelines emphasize that clinicians understand that therapies, when possible, should be chosen that are organ selective or organ specific prior to administering systemic therapy.
For instance, the guidelines advise physicians to consider non-systemic corticosteroids such as budesonide MMX before the use of systemic therapy in patients with moderately active UC that have not been hospitalized. Additionally, the guidelines suggest that 5-aminosalicylates can be used as a monotherapy for induction of patients with moderately active UC.
Hospitalized patients
Another important aspect of the guidelines include an entire section on hospitalized patients with acute severe UC and “how to approach those patients in consideration of treatment options in the hospitalized setting, including evaluation and treatment of Clostridioides difficile (CDI), prevention of venous thromboembolism complications and recognition that after 3 to 5 days of IV steroids, the patient who is not responding should be moved onto other therapies,” Rubin said.
Significant concept statements from this section include:
- all patients admitted with acute severe ulcerative colitis (ASUC) should have stool testing to rule out CDI;
- when identified, CDI should be treated first-line with vancomycin instead of metronidazole;
- all patients with ASUC should undergo a flexible sigmoidoscopy within 72 hours, and preferably within 24 hours of admission;
- all patients with ASUC should be assessed for the presence of toxic megacolon on a regular basis during the hospital admission; and,
- NSAIDs, opioids and medications with anticholinergic side effects should be avoided in ASUC.
Colorectal cancer prevention
Another important item that is an update to the previous UC guidelines is the addition of colorectal cancer prevention.
“The guidelines acknowledge the increased risk of cancer in the patients with UC related to degrees of inflammation and a variety of other previously described risk factors and discuss the approach to screening and surveillance with advancing technologies including high-definition colonoscopes. The guidelines acknowledge that narrow band imaging might be an option in some patients instead of dye spray chromoendoscopy. This may be a relief for some clinicians who feel like dye spray was burdensome and something that they hadn't really learned to do well,” Rubin said.
Important concept statements that were written in the guidelines include:
- screening and subsequent surveillance colonoscopy to assess for dysplasia in individuals with UC of extent greater than the rectum should start 8 years after diagnosis;
- patients with UC and primary sclerosing cholangitis should undergo a screening colonoscopy at the time of diagnosis of UC and surveillance annually thereafter; and,
- surveillance colonoscopies in patients with UC should be performed at 1- to 3-year intervals based on the combined risk factors for colorectal cancer in UC and the findings on previous colonoscopy.
Making the guidelines ‘practical’
A common concern that has been growing across all medical specialties, and not just for gastroenterologists, is that clinical practice guidelines are not being followed accordingly and are sometimes even hard to understand.
Long and Rubin both acknowledged that the committee took that notion into concern and made sure to address them.
“The guidelines committee and the authors took this to heart in our development of the guidelines document,” Long wrote in an email. “Our first goal was practicality. We wanted this document to be useful to the clinical provider and inform as many aspects of UC management as possible.”
Rubin elaborated and said the committee was sensitive to the issue because they knew that if the guidelines were too complex or not in touch with the real world, that it would just be a document that no one would use.
“When we wrote these guidelines, we wanted to keep in mind not just what is happening and what [does] the clinician who is taking care of a patient need to do, and how will they do it, but also, what are some of the sticking points for payers currently, [and] where the guidelines might provide them some added strength and support for advocating on behalf of their patients,” he said in an interview. “A good example is fecal calprotectin, which we include as a recommendation and an option for patients to evaluate them instead of endoscopy. That’s an issue that payers have bumped on.”
Additionally, Rubin mentioned that the committee did not describe mildly to moderately active UC and moderately to severely active UC, but rather mild on its own because most physicians are likely thinking about a patient who is mild or a patient who is moderate to severe.
“We really tried to be practical in the way we think about this so that people will use these guidelines,” Rubin said. “The last example of [this] is simplifying colorectal cancer surveillance. There was a disconnect and that the message had been that people should be using dye spray chromoendoscopy in all of their surveillance, and yet we know that our colleagues were not doing so for a variety of obvious reasons. When reviewing the evidence and also demonstrating that we don’t yet know what approach actually reduces colorectal cancer incidence cancer or mortality, we acknowledged that other technologies may be sufficient, and we can approach patients with that in mind.”
The guidelines, as both Long and Rubin noted, took 2 years to complete, but allowed for formidable reviews from colleagues.
“The incorporation of these comments led to a much stronger document,” Long wrote. “The guideline timing was such that we could incorporate all of the newest classes of therapies for the management of UC. We therefore feel that this is a thorough and quite timely document.” – by Ryan McDonald
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Disclosures: Rubin reports serving as a consultant or on an advisory board for AbbVie, Abgenomics, Allergan, Ferring, Genentech/Roche, Janssen, Medtronic, Merck, Napo Pharmaceuticals, Pfizer, Shire, Takeda, and Target Pharma Solutions. Rubin also reports research support from Takeda. Long reports consulting and research support from Pfizer and Takeda, as well as consulting for AbbVie, Janssen and UCB.
Perspective
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Edward L. Barnes, MD, MPH
The new clinical guidelines for ulcerative colitis in adults from the American College of Gastroenterology are a great service to practicing gastroenterologists in the care of patients with ulcerative colitis. One of greatest benefits from the structure of these new guidelines is that they are practical and written in a way that providers can evaluate the strength and weight of individual recommendations (using the GRADE system) along with the clinical scenarios where decision-making is occurring. The transparent approach to multiple presentations of ulcerative colitis –from the patient with mild activity to those patients who are hospitalized and being treated for acute severe ulcerative colitis – allows providers to assess the disease state and activity of an individual patient they are treating, and then make a rational and guided decision about the next steps in management. Additionally, the separation of recommendations among outpatient management of ulcerative colitis by mild activity and moderate to severely active disease states allows for a natural separation that in my opinion, aligns more with how providers approach therapy decisions in patients with ulcerative colitis.
Among the most important recommendations outlined in the new guidelines are those identifying the induction and maintenance therapies of patients with moderate or severe colitis. The treatment armamentarium for ulcerative colitis is rapidly expanding, and the authors seem to have strived to evaluate and incorporate each of the new mechanisms and approaches to therapy for ulcerative colitis, the majority of which have significantly expanded in the interval since the most recent guidelines in 2010. For example, in the management of moderately to severely active ulcerative colitis alone, the authors detail several potential decision points including induction with an anti-tumor necrosis factor (anti-TNF) where combination therapy with a thiopurine is recommended for infliximab (strong recommendation, moderate quality of evidence), and the treatment of patients after anti-TNF failure, where the use of vedolizumab (strong recommendation, moderate quality of evidence) or tofacitinib (strong recommendation, moderate quality of evidence) are discussed in detail. There is also an expressed theme within the guidelines to focus on the goals of both the patient and the provider, which is a critical concept of communication and decision making given the chronic nature of ulcerative colitis.
Finally, I feel that the section on colorectal cancer prevention in ulcerative colitis will continue to advance our decision making and management of patients with ulcerative colitis. The authors have used the extensive literature in this area of IBD to summarize the current thought of colorectal cancer prevention and do an outstanding job of presenting the data supporting multiple discussion points in colorectal cancer prevention. These include several GRADED recommendations, as well as the introduction of key concept statements, which are particularly helpful and will likely promote further discussion in areas where controversy is thought to exist (such as the need for segmental random biopsies during surveillance colonoscopy for ulcerative colitis).
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