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Corey Siegel, MD, on Applying IBD Guidelines in Practice
In this video, Dr Siegel, from Dartmouth-Hitchcock Medical Center, reviews his presentation from the Advances in Inflammatory Bowel Diseases 2020 virtual meeting on applying professional guidelines in real-world gastroenterology practice.
Corey Siegel, MD, is director of the Inflammatory Bowel Disease Center at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
Hello, I'm Corey Siegel from the Dartmouth-Hitchcock Medical Center. I'm going to give you a summary of a talk I gave at AIBD 2020 about applying IBD guidelines in the real world. There are a lot of IBD guidelines. Just over the past few years there have been over 150 that were published, many of them overlapped.
Some are conflicting. The obvious ones seem to be obvious. Truly the tweeters, those ones where we have a lower level of evidence that we have a harder time with findings practically and in the real world. I decided to pick just 5 guidelines that come from various sources to discuss with you briefly in summary if you weren't able to catch the entire presentation.
These are looking at the ones that I refer to as high-hanging fruit as opposed to the low-hanging fruit that are more obvious. We're the ones that need to be more thoughtful about and how we actually apply these guidelines in clinical practice.
The first one I'll mention is from the ACG ulcerative colitis guideline 2019 that discusses mucosal healing. A lot of pushback that we get about mucosal healing is that it's hard to get everybody with complete mucosal and histologic healing.
That's true, there's a fairly low proportion of patients even in clinical trials, where we get people with a completely normal colon during endoscopy. The guideline states that we suggest treating patients with UC to achieve mucosal healing.
This is defined as resolution of inflammatory changes and a male score of 0 to 1. That's a big difference than 0 which is a perfectly normal colon; 1 still allows for some granularity, erythema and mild inflammation.
Although we are going for complete mucosal healing, it's much more reasonable to be looking to achieve a subscore of 0 to 1 from the Mayo endoscopic scale so that we try to push as hard as we can without cycling through drugs so quickly that we run out of medications trying to make it perfect.
This is often where I state that perfect is the enemy of good, and we should do the very best we can and be realistic.
The second comes from the AGA moderate to severe ulcerative colitis guideline was published in 2020. It states an adult outpatient with moderate to severe UC who were naive to biological agents, the AGA suggests using infliximab or vedolizumab rather than adalimumab for induction of remission.
The reason I bring this up is that most payers are insisting that we use adalimumab or Humira as first line for ulcerative colitis, but now, we do have data to support the fact that infliximab or vedolizumab might be better.
The data comes from two different sources. One is the VARSITY trial that was published in the New England Journal of Medicine in 2019 by Bruce Sands that shows vedolizumab beat adalimumab in a head-to-head study looking at induction of remission for patients with ulcerative colitis.
Now, we have data that you can use for your insurance companies, for your payers, to help support using vedolizumab over adalimumab.
The other paper I mentioned is from Sid Singh published again this year 2020 in CGH, which looked at a network meta-analysis of all the biologic agents and bio-naive moderate to severe UC, and they ranked the agents as far as most effective to least effective, and the most effective was infliximab.
If you're working with payers trying to get out of infliximab or vedolizumab, we now have data for both of them to be used over adalimumab as first line. This is in sync with the guidelines published by the AGA this year.
Next is the ACG management of Crohn's disease from 2018. I'm going to say something that people already know, which is it is encouraging us not to use oral mesalamine for the treatment of Crohn's disease.
As you know, we've been talking about this for years however, recent data show us that even 30% to 40% of patients with Crohn's disease are getting the mesalamine treatment as first-line therapy. We have multiple sources to show that's not effective. We have the ACG telling us not to use it. These are tough patient groups, patients with mild or mild to moderate Crohn's disease.
I'll tell you that my practice, the way that I practically do this is recognize that not all patients need treatment. There are patients where you can just treat symptomatically when they have mild Crohn's disease as long as you follow them carefully.
Make sure they're in a category that's at low risk for progression and keep a very close eye on them making sure they're not progressing, again staying away from mesalamine for our patients with Crohn's disease.
The next topic is about postoperative management. We learned for years from one of our hosts, Miguel Regueiro, that using infliximab postoperatively is an effective treatment after surgery. The guidelines from ACG state that in high-risk patients anti-TNF agents should be started within 4 weeks of surgery in order to prevent postoperative recurrence.
The important things here, number one, it's within 4 weeks of surgery, not 4 months of surgery, but really trying to get our patients on the appropriate medications postoperative.
The second is why are anti-TNF favored. It's because yet another network meta-analysis, this one published by Sid Singh in Gastroenterology in 2015. They look at all the different agents that we can use in postoperative prophylaxis in patients with Crohn's disease.
Anti-TNF therapy came out on top. Anti-TNF therapy being used as a first choice, others work as well and to use it within 4 weeks.
The last topic just for a quick bullet is about therapeutic drug monitoring. We've been talking about this for years. The AGA back in 2017 made a comment about TDM. I don't completely agree with their statements that's why I want to highlight it. They suggest that using them for reactive drug monitoring after the fact the patient's failing in drugs is recommended.
However, they say that they have no recommendations on what to do for proactive monitoring or therapeutic drug monitoring preventing patients from losing response and optimizing the drug proactively. Yet, data have accumulated since 2017. In fact we have a very well done randomized control trial on a pediatric population that shows in fact there's an improvement and sustained steroid-free remission.
If you go back on retrospective data, although not the ideal study to do it, but the best that we have, a paper published out of Beth Israel Deaconess Medical Center in Boston in 2017, we see that proactive management of drug levels helps decrease IBD-related surgery and decrease IBD-related hospitalizations.
We're starting to close the gap. I can't say that we have such strong data that we should do this all patients without question, but as far as TDM, we should definitely be doing it reactively. We're getting more and more data now to support the fact that we should be doing it proactively.
Thank you for your time. I'm sorry that we can't be there in person. I look forward to seeing you in a AIBD 2021, hopefully, in person. I hope we had a great day and a great holiday season.