Transcription:
Biologic Therapies for IBD

Melanie Cole (Host): . Welcome to Better Edge a Northwestern Medicine podcast for Physicians. I'm Melanie Cole. Joining me today is Dr. Parambir Dulai. He's an associate professor of medicine in the division of gastroenterology and hepatology at Northwestern Medicine. And he's here to highlight biologic therapies for inflammatory bowel diseases. Dr. Dulai, it's a pleasure to have you with us. This is a really great topic. I'd like you to start by telling us about the current state of Crohn's and colitis today, the inflammatory bowel diseases. How has treatment evolved over the years? Do you have any exciting update and tell us what you've been seeing in the trends?

Dr Parambir Dulai: Yeah. First of all, thank you so much for having me on the podcast. I'm really excited to be here. And this is a very important topic, not only for the field, but for me personally as well the field of inflammatory bowel disease, both Crohn's disease and ulcerative colitis has grown tremendously over the last couple decades. And particularly in the last to two years, we've gone from a history of prescribing chronic steroids, or immunosuppressives like thiopurines to more selective biologic agents like anti TNF therapies.

And in just this last year, we've actually had three new drugs approved that were not available before. And we're anticipating at least maybe one or two that are going to be available leading to a tremendous amount of choice and opportunity to help prevent a lot of the debilitating complications that these IBD patients suffer from on a chronic basis.

Melanie Cole (Host): Yeah, that's a good point. So this is very exciting work that you're doing. Can you tell us about your role at Northwestern Medicine and specifically your work on biologic therapies for inflammatory bowel diseases?

Dr Parambir Dulai: Yeah, absolutely. so my specific role here is that I'm the director for GI clinical trials and precision. And so within that role, a lot of my research has focused on trying to bridge some of the gaps we have in evidence for newer therapies as they come to market, and trying to help better personalize decisions for the growing choice that we have for these biologics. So when it comes to bridging gaps in evidence, we have built a large multicenter about 20 academic sites across the US, collaboration of IBD providers who are looking to create data sets that can help us understand how well these drugs work for our patients in practice, and who they work the best for.

And the second part of a lot of what I do is taking a lot of that data and building decision support tools. So one of the things that we've been very fortunate about is being able to work both with academic partners in the community and other sites, and also industry partners, to be able to access a lot of the clinical trial data. And within that, we've taken clinical trial data, we've built easy to use decision support tools for the biologics that we have. And we've shown that those decision support tools actually predict which patients are gonna do well on specific therapies and which patients are gonna do better. And choice should probably be considered as a first line therapy for a lot of our IBD patients.

Melanie Cole (Host): So, this is fascinating, what an exciting time to be in your field. And there's an advent of biologic therapies for the treatment of these inflammatory bowels. So what's the greatest challenge to prescribing biologics and small molecules for IBD currently?

Dr Parambir Dulai: Yeah. I think the greatest challenge that we're seeing right now is that providers feel a bit overwhelmed. And I think with the growing choice, we have to begin to try to understand how we actually make these decisions. In real time for patients who are sitting in front of us. And so, one thing that we've done to help overcome that is we've actually made a web based app that is now endorsed by the American gastroenterology association where physicians get CME credits for using it.

And it's called the CDSTforibd.com, where you can actually go onto this website. You can input information for the patient that's sitting in front of you, and it will tell you whether that patient's at risk for a complication from their IBD and what biologic they would be best suited for to help avoid those complications in the long run.

Melanie Cole (Host): So then tell us a little bit about how providers can address this paradox of growing choice? There's so many now, while ensuring patient engagement?

Dr Parambir Dulai: Yeah, that's a great question. So what we've seen is that for the website that we've actually created. Brings together all of our decision support tools. When providers use that tool, we've studied how much more effective and confident they become in their decision making. And we've seen that among the 8,000 users across the US, that the rise in mastery, both confidence in knowing that you got the right answer and actually getting the right answer, has risen over 200%. And one specific thing is that because of the display of the web-based tool, you can actually show it to the patient.

So I think when I've used this personally and when others have used it and commented on it, they've said that showing the patient for them, that one specific drug is going to do as well or better than another one. And then using that to guide that shared decision making process has tremendously improved the engagement from the patients and has helped level set expectations for what they should be expecting in terms of when the drug is going to work and when they should be following up to make sure that we're making the best of these drugs, when we start them.

Melanie Cole (Host): And what about the standard therapies such as thiopurines? How has that role evolved in IBD what are we looking at with that?

Dr Parambir Dulai: Yeah, historically, thiopurines and some of those broader non-selective immunosuppressive drugs had a mainstay in our treatment paradigm, but we're really shifting away from that. We now have both biologics, which are large molecule drugs and small molecule. Pill versions of drugs that are replacing thiopurines as a primary treatment. And so we really think of thiopurines as just an add-on therapy to some of our drugs to help them work better. But biologics and small molecules are becoming the cornerstone of management for moderate to severe inflammatory bowel disease.

Melanie Cole (Host): Dr. Dulai, can you tell us about the available decision support tools? You mentioned a little bit about the website before and that providers can use in practice to guide their use of biologics and small molecule therapies. Tell us a little bit about those support tools and what has your experience or the experience of community providers been with these decision, support tools? HOw have they been working?

Dr Parambir Dulai: So the nitty gritty of the decision support tools is that we access the patient level data from the phase three clinical trial programs for vedolizumab ustikinumab infliximab, and some of these other drugs that have come to market. And we built decision support tools that have an easy calculator. You assign a couple of points for each different discrete variable. Like you get a certain score based on the albumin value, the CRP value, prior surgeries, and then spits out for you a relative probability of response to that specific drug.

And what we then did is we validated that in our routine practice cohorts, and we've actually now validated it with other groups in Europe and Asia showing that each tool is actually very specific for the drug that it was built for. Meaning, our decision support tool for vedolizumab, for Crohn's disease, predicts outcomes for vedolizumab and Crohn's disease, but it does not predict outcomes for kinumab or anti TNF therapy. And similarly, our ustikinumab tool predicts outcomes for ustikinumab, but not for vedolizumab or anti TF therapy.

And so we've gone through multiple validations to show that the specificity of these tools is there. And that they're relatively easy to implement. And I think that last part, the ease with which you can implement these is what the community providers really love. They love the fact that it takes about a minute to input the data, to spit out a result, and to use it in clinic, to actually show patients and to make decisions on how to guide a discussion for what a patient should start, how they should start it.

Whether they should follow up with drug level testing, when they should follow them up to look for resolution of symptoms, and when they should make a decision to move on to the next therapy. And so we've seen tremendous growth just this past year alone. The usage of the tool has grown over 300% and now with official endorsement by our National Gastroenterology Association Society, I think the growth is gonna continue to go and. Updating it constantly with newer tools that come to market.

So we've been very pleased and excited with how this has gone. And we think the community providers that we've spoken to have really taken to it and feel like it fills that gap that we've been talking about.

Melanie Cole (Host): What an excellent support tool that, that is for other providers. And I know as we're talking about these biologics and treatment options, there are so many now, and with increasingly complex treatment algorithms that are adding these new options to your armamentarium of available therapies. I'd like you to speak for just a minute on the multidisciplinary management and how that ties into this picture of decision making, shared decision making and personalized medicine?

Dr Parambir Dulai: Absolutely. So our goal with these tools was to enable frontline providers, the people who are seeing these patients in the community to do the best they possibly can to make that decision and monitor that decision. However, no decision in medicine is done in a vacuum. And so the multidisciplinary component of this is you need to make sure that you think about other aspects. So nutritional components are often brought in, especially for patients who have low Albumen.

Consideration for psychology and the gut brain access is a big thing that we're doing here at Northwestern Medicine for IBD patients, and really close collaboration with our surgeons. So At Northwestern Medicine in particular, we do bring together multiple disciplines to work together, to optimize outcomes. And we are here for our colleagues. And so if you have questions that we are readily available to just answer them and help support you, whether it's remotely or through a referral system.

Melanie Cole (Host): And yes, you are doing that exciting research on the brain gut connection, and we've done a podcast listeners can listen to about that very thing. And thank you for telling us about this sort of holistic model of care. That's recognizing the complexity of these inflammatory bowel diseases and the evolving role of diet and triggers and stress and all of those things that you mentioned. As we wrap up Dr. Dulai, what should physicians interested in exploring biologic therapies for their IBD patients keep in mind? And when would you like for them to refer to the experts at Northwestern Medicine?

Dr Parambir Dulai: So one thing to always keep in mind is that we are always available for curbside questions or support. You don't need to necessarily send your patients if you feel like you're comfortable managing them, but also don't hesitate to reach out. Out when you should really think about referring a patient over for specialty sort of expertise or secondary consultation, is if they failed two or more therapies. At that point, the incremental yield for the subsequent therapies goes down tremendously.

And we really want to do a good job of trying to make sure that we optimize that decision in particular, because it represents a critical juncture where we can either save that patient from a complication, or we might miss that opportunity. And always welcome involvement to make that decision and support that decision and to help patients really get the most they can from the drugs that we.

Melanie Cole (Host): So many exciting advancements, Dr. Dulai, what a great guest you are. Thank you so much for joining us today and sharing all of this exciting news in the field of inflammatory bowel disease. Thank you again. And to refer your patient or for more information, please visit our website at BreakthroughsforPhysicians.NM.org/gastro to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine podcast for physicians. I'm Melanie Cole.