Welcome Patient: Emily

Angelina Collins: All right, so let's get into it. We're going to welcome Emily. She's going to come on, she’s been waiting for us backstage to jump in and tell us about her experience. Emily, thank you so much for joining us. It's always so wonderful to hear your experience, and I'll let you kind of take it away because we've learned so much from you and we're so grateful that you're sharing your experience with us. And tell us a bit about your experience with Crohn's. Maybe the good, the bad, the ugly, however you'd like to exchange with us.

[00:18:13]

Emily Bennett: Absolutely. First of all, thank you so much for having me. I really feel honestly honored, almost, to be able to share my experience and also that people are interested in hearing about my experience so that they can hopefully better treat sort of the next wave of people living with Crohn's disease.

So of course, as the slide says I was diagnosed at age 19. I'm 39 now, so I've been living with Crohn's Disease for about 20 years now. I always tell people that I sort of initially had a relatively easy experience getting diagnosed, which I think says a lot about how difficult it is for people to be diagnosed. So I was living with symptoms for about 6 months. You know, all sorts of pain, distension, I wasn't able to eat, like, you know, I was getting sick all the time. It was really awful. I finally wound up getting hospitalized because my symptoms sort of reached a head, and they did some imaging on me, looked at me, and they were like, ‘Yeah, pretty sure you've got Crohn's disease.’ And from there I was able to begin my treatment journey.

Unfortunately the first provider that I worked with, I didn't feel a really great connection with her. I didn't feel like she listened to a lot of my concerns. And to be fair, you know, she wanted to do a very, what would you say? Not a very aggressive term of treatment. But for me, somebody who had moderate to severe Crohn's disease, unfortunately I really did need some of, as my current doctor calls it, the big guns to kind of come in and get my inflammation and my symptoms down.

And so once I found my second provider, I was able to really connect with him. I felt like he understood me, understood what I was going through, because I was diagnosed at such an early age. You know, when you're a teenager, having to talk to somebody, even medical staff, about all these things that you're experiencing, you know, going to the bathroom, bowel habits, as a young person, it can be kind of awkward and embarrassing to suddenly have to talk about something that you feel is very private. But he really made me feel at ease. I felt like I could connect with him and he understood, you know, my struggles and my problems. And so because of that, we were able to make a really good treatment plan. And, you know, we've been together for over 15 years now.

Angelina Collins: That's great to hear.

Emily Bennett: Yeah. And so, because he took my concerns seriously, I'm now able to, you know, live a relatively normal life, which is just really wonderful.

[00:21:23]

Angelina Collins: Yeah, I really appreciate hearing your story, and I appreciate hearing, you know, as I said it earlier, the good, the bad, the ugly. Because I think 1 of the things that really resonated—I've heard your story or different parts of your story before, just to be fair to the audience—but 1 thing you said this time, which I hadn't really heard before, maybe, or maybe I didn't hear it in this exact way, because you may have said it before, but I didn't hear it in this way—it's really interesting to me that there was a disconnect between your symptoms and actually what you wanted as a treatment plan and what you were being offered with your first provider, I think. And that's kind of interesting because I think for some providers it's hard to sometimes make that leap and say, ‘Hey, I think we need to move on from here.’ And so that can be a challenging conversation for us on the provider front to make sure we're giving the best treatment choice, obviously, to our patients to have the best outcomes.

I'm asking this on the fly. You haven't heard this question before, but I'm thinking, how did that conversation go with your second provider that might've helped you? Like was it that you were asking for something with your first that wasn't happening? Or was it just like, you felt like you were floundering and just didn't have symptom control? Or did your second provider present it to you in a different way that made it resonate to you that, yeah, there is something else out there that I could be on to feel better and to help the inflammation. What does that strategy look like from a patient perspective? What was successful with the second provider?

[00:22:50]

Emily Bennett: Absolutely. So of course I got diagnosed quite a while ago, and when I was sort of first experiencing my diagnosis, you know, biologics and things like that were relatively new. They had just kind of come onto the scene. And so because there wasn't a lot of data about it, I think my first provider was like, well, you know, we don't want to rush into uncharted territories. But of course, at the same time, I was also getting stuck in this horrible cycle of, you know, I would have symptoms, they would get out of control, I would have to go to the hospital, and then I would have to be on steroids and things like that. And that was just a really awful experience. because As I'm sure you know, the side effect profile for steroids is pretty intense.

Angelina Collins: Yeah.

[00:23:49]

Emily Bennett: But what I really enjoy about my current provider is that he's really, really well versed. He loves to attend conferences, he likes to really stay kind of on the cutting edge of what's going on, what are we investigating, what are we testing, trying out. And you know, I really appreciate that he actually was the one who presented me with the option. I had sort of thought like, well, my options are, you know, taking 7, 8, 9 pills a day and hoping for the best. But he was the one who actually presented me. He's like, you know, ‘I've got some things that we can try. Here's all the information I have.’

Angelina Collins: Got it.

[00:24:32]

Emily Bennett: ‘Here are the risks, here are the benefits, and here's why I think the benefits are going to outweigh the risks in the long run for you.’ And I'll say he really empowered me to kind of feel like I was making the decision, like we were partners in making the decision. And I just really appreciated that like, you know, he wasn't like, ‘I'm going to tell you what to do. I'm going to tell you what's best for you.’ He made me feel like I had real choices in my healthcare, and because of that, I felt comfortable to pursue that as an option.

[00:25:14]

Angelina Collins: So it's funny, like the term behind that is called shared decision-making, which sounds, you know, but it's so true. And I'm like, oh my gosh, you're totally talking about what that looked like and what that conversation actually looked like. And it's funny, as you say that I usually try to present that, you know, do the risk benefit analysis with people. And then I also talk about not just the risk benefit of the medication, but like, where are we now and where is this disease course headed if we don't do something different? Like, you already know what it looks like, right? You had seen that cycle you know, several different times. And so I appreciate that that concept of pulling people into the conversation and making you feel empowered was really what helped you to know though that also that this was a good option for you to try something different than what you had done before and be willing to make the leap into another direction.

So I think that helps us as providers, you know, I think these conversations with you really help because it helps us with providers to understand like, what's the best approach we can take and how do we best? Because really, I mean, most of us are motivated by like, how do we help people? Like, people are coming to us in a not great way, and how do we make that better? So I think that's really wonderful.

We're going to bring you back. I'm just looking a little bit at the time. We're going to bring you back to talk in a few slides about some other fun topics and, you know, difficult to discuss topics, so you can help us more with how to have better and more impactful conversations with patients and how can we do that really well. So thank you again for all of your experience, your willingness to talk about this. You know, I mean, I think it is, your honesty is amazing, but like your willingness to discuss and share, you know, sometimes like these awkward situations— actually nothing you've talked about is awkward, quite frankly. Because everything is so—we hear this so often with Crohn's. We actually just need to normalize the conversations really, quite honestly. But I appreciate that outside of a visit, you're willing to do that, because that is still putting yourself out there on the line. So thank you for that.

Emily Bennett: Yeah. Like I said, it's my absolute pleasure. So I will go back into the shadows and when you need me again, just ring.

[00:27:19]

Angelina Collins: We're going to call you back up soon. All right. So while Emily's taking a break and getting a sip of water, we're going to dive into the next section of the slides.

[00:27:30]

Presentation

Treat to Target in CD: Where are we now?

I would like to tell you that this is a downloadable slide deck. So if you are interested in doing so, if you click on the bottom of your screen, you see a button that says Resources, you will have a copy of the slides. You can download them now if you want to follow along or have them for later. I'm going to cruise through this first section, and we're going to talk about some different things and hopefully try to pull all this together.

[00:27:56]

Review of STRIDE I with Advancements to STRIDE II

So when we really think from a provider perspective about how do we go about thinking about Crohn's disease and what's the way that we can go about doing this, I think a lot of us come back to the STRIDE guidelines. So this was a group of guidelines put together by the International Organization of Inflammatory Bowel Disease, or IOIBD. It's a group of really key opinion leaders across the world that come together and they're really trying to push forward and enhance practice. So that's really the whole idea.

STRIDE I started with establishing mucosal healing in clinical remission as primary treatment goals. The limitations at the time that the STRIDE I guidelines came out was that there wasn't sufficient data on biomarkers and transmural healing to make specific recommendations about those.

So now then the update comes, STRIDE II, and that incorporated advancements. So by then there was enough data on biomarker monitoring. Fecal calprotectin and CRP are the most common biomarkers that we use in Crohn's disease. And then thinking about individualizing goals on disease phenotype a bit, and then talking about mucosal healing.

[00:29:03]

STRIDE II: Dynamic Treat to Target

So let's look at how this is, because I think this next slide really tells us a bit about how can we think about treating and how do we think about treat to target. So this, I also say, if you've ever heard me speak before, I often say the same thing: this also keeps us honest. Because if you look from left to right and you walk through this, you can think about this as a really nice pictogram of what do we do with people who have and are living with Crohn's disease, or ulcerative colitis for that matter, right? You know, when you think about where their journey starts on the left-hand side, they have active disease. Let's say they've recently been diagnosed or they're coming to see you in a flare, there's active inflammation.

The next thing is to think about therapy according to risk. So you're selecting a therapy according to their risk. We're going to talk about that in a second and how to select therapies, what therapies are available. You'll see that in a slide.

And then the next thing is to think about are you hitting treatment goals? And the reason I say this keeps us honest is because we have to make sure that after we select a therapy, that we're coming back around to think about, are our patients getting better? Is there normalization of the biomarkers: normalization of CRP, decrease in fecal calprotectin as the intermediate goals. And then long-term, we also want to see that there's endoscopic healing going on. Is there response endoscopically? Is there improvement? Are they getting to normalization? And in kiddos, we absolutely want to see that the kids are growing right.

Now, STRIDE II said that you could consider, but non-formal targets were in Crohn's disease transmural healing, or for ulcerative colitis histologic healing.

[00:30:39]

Goals and Timelines for Moderate to Severe CD

Okay? So what does that look like? So when we really think about timing on all of this, we think about resolution of symptoms within 3 to 6 months. We think about biomarkers normalizing also within 3 to 6 months. Endoscopic, you want to go back and often you're really looking and recommending an endoscopy to look and assess for mucosal healing within 6 to 12 months. Then we think about long-term, like our work is really never done, right? This has to be an ongoing assessment because, you know, sometimes our patients will flare, unfortunately, right? And so we'll be kind of starting this process all over again. But really it's an ongoing assessment to make sure that people's quality of life is excellent and that we are really moving forward and that people can live with their Crohn's disease and not really have life limiting because of their Crohn's disease, right?

[00:31:25]

Endoscopic Characteristics of CD

So in order to think about how do we select a therapy, we have to really think about disease activity, which is how active is the disease now. That's basically saying what does it look like on scope or scopes and/or imaging. So when we think about some classic characteristics of Crohn's disease endoscopically, you know hallmark feature is to think of healthy mucosa next to diseased mucosa. So that means that there's active areas of inflammation and then there's active areas of normal looking non-diseased activity. There's typically these segmental involvements.

When you have mild disease, there's apthoid erosions or maybe superficial ulcers, like what you see in the upper right hand photo. There's typically rectal sparing. Not always. If you see rectal activity, that's really a sign, or perianal disease. And you know, 25% of our patients will present with perianal disease. But that's typically something that we want to be a bit more aggressive about.

There could be cobblestoning, and the middle left picture kind of shows us a little bit about cobble stoning and also these long linear ulcerations. All that white is all the ulceration. The upper left-hand side, you really see some severe disease activity and see an ulcer that's kind of going right through the middle there as well. And then toward the lower left, you also see this long linear erosion as well.

And over on the lower left-hand side, you really see stenosis, right? Like this is a tiny inflame. You see all this inflammation, all the swelling and edema, and then you see this little tiny aperture. And here's the biopsy, like the forceps instrument it looks like, which you can see how tiny the opening is. You can see how narrow the stricture has become just with the forceps biopsy right there. And sometimes you may see fistulas, although typically they're very, very, very difficult to see on endoscopy. Alright?

[00:33:22]

Low vs High Risk Features for Disease Progression

So once you're thinking about endoscopy, so that's 1 piece of the puzzle. The second piece of the puzzle you're really thinking about, is this patient high risk for disease progression. So you're thinking about disease severity and activity, and you're also thinking about risk for progression, to label that person as, you know, these are very crude things. It's like low risk for progression or high risk for progression.

So if we just look at the high-risk features, we think about people that are diagnosed less than age 30, who may have a more extensive anatomic involvement compared to a limited anatomic involvement. If there's deep ulcers present, so on the pictures back you saw some deep ulcers, they looked really yellow and you know those linear ulcers are typically deep ulcers; if there are stricturing or penetrating patterns; if they've had a prior surgical resection; and if they have perianal disease, they are automatically in that high-risk category, even if there's no other luminal disease activity.

[00:34:16]

Medication Options for IBD

So, important to think about that because then as you jump into what options of medications can you use for IBD – this is all IBD, so not all of these as you will see and know probably already, not all of these are approved for both Crohn's and ulcerative colitis. But let me kind of walk you through this. The navy blue are conventional therapy medications. The green are the biologic medications and the yellow are small molecule. And next to each of these, you can really see are they FDA approved for Crohn's disease, ulcerative colitis, or both. So you have a nice way of being able to kind of look at that.

[00:34:52]

Medication Options for CD

As we go to the next slide, we're really looking specifically about what can we do specifically for Crohn's disease, since we're really focused on that this afternoon or this evening, depending on where you guys are located. So we think about some of the conventional therapies like steroids, aminosalicylates, immunomodulators.

I did not know that Emily was going to talk about steroids as being, you know, how challenging those are from a side effect perspective. I often say that, you know, they can be fantastic because it works really quickly, but it is not something we want to use anymore to keep people on long-term maintenance, right? You don't want people on steroids long term. It can be so challenging with all the possible side effects, short and long term. There's a lot of people that just don't tolerate steroids. So there's a time and a place to induce remission, but we have to be thinking about what we can use long-term.

When we think about aminosalicylates, they are no longer recommended for the treatment for Crohn's disease, even mild Crohn's disease, really not recommended either.

Immunomodulators are typically not used by themselves, but have a real great adjuvant therapy point, especially with the anti-TNF medications.

And as you come into the biologics, there's a wealth of biologics that actually even since – we haven't yet updated this slide. We need to update this slide because guselkumab, as you well know, has been approved just in the last couple of weeks for induction and maintenance of Crohn's disease. So there's another option. We're so lucky to have more options available for people, biologics available and small molecule and 1 small molecule for Crohn's disease to choose from when we're thinking about therapies.

So with all of this comes also challenges. What do we pick first? What do we pick second? What is that going to look like, right?

[00:36:42]

Proposed Treatment of CD

So there is a proposed treatment of Crohn's disease for the low risk patient on the left hand side. I'd just like to point out that there are updated guidelines that should be coming out shortly. I know the A GA guidelines are in process of being updated and they'll be published shortly. So I realize that these ones are looking at some of the older guidelines, but it just gives an idea. The low risk patient really hasn't changed a whole heck of a lot, you know, since then. So you'll notice that it looks pretty similar probably what you're doing now, thinking about budesonide or a tapering course of prednisone, especially if you can't get budesonide covered, that can be super challenging sometimes to get it covered for some of our patients. But where you can use it, it can be a really good option.

But then keeping in mind, like how do we think about progression? Like what happens if people aren't responding to the initial treatment that you give for a medication when you're a low risk patient or you think, you know, this person's not responding, I don't think this is a low risk or a low or mild disease activity patient anymore. Then you really need to move on. And now all of a sudden they have, as 1 of my docs would say, they've declared themselves. I think that's a great term to use. Like, okay, we tried this process, this is not moving in the right direction, we need to think about what to do next. And now we can think about them as moderate- to high-risk patients.

So we think about options including anti-TNFs. And oftentimes, you know, the anti-TNFs may be considered first-line therapy in this last iteration. And now we have other options as well though, right? Anti-IL 23s. Upadacitinib is not to be used as a first-line therapy because of the US FDA label. If you were in Europe, you could use it that way, but you can't in the US, so we'll keep the conversation based on US approvals. But now really what you're going to see as well is that when the guidelines are being updated, they're going to move more toward the IL 23s as well, I think. So you'll see some of this in the future or, you know infliximab, or anti-TNFs I should say, including adalimumab as well.

[00:38:47]

Proposed Algorithms for Moderate to High Risk CD

So here's the proposed algorithm for moderate to high risk. I kind of talked about this a little bit on the last slide, but if there's severe disease you know, fistulous disease activity, anti-TNFs are still considered as the prime therapy, probably in combination with thiopurine or methotrexate. And you would consider, again, this was looking at data that came out looking at options here and thinking about infliximab over adalimumab combination therapy, over monotherapy. But if there's always, you know, a risk adverse patient, serious prior infections and malignancies, advanced age, multiple comorbidities, you may need to think of non anti-TNF options. Again, this is coming from 2020 data, so I think you'll see some of this where there's an IL 12-23 like ustekinumab. I think you're going to see the IL 23s with future iterations of an algorithm like this, I expect.

So something for us to think about. It really means that there's options for our patients. I will tell you when I think about patients with infections or I think about people who are risk adverse, I think we do need to really highlight the conversation about the risk benefit of the medication and what is the risk of uncontrolled disease. Because often you see increased risk for serious infections where there is ongoing inflammation. So I just always like to point that out to be fair and balanced about what this is all going to look like when we're selecting therapies and being open to our patients. Because our work is for our patients, right?

[00:40:30]

CALM Trial

Now when we think about the CALM trial, this was a really important trial that really focused on saying that symptoms alone are not enough and that we really need to make sure we are driving our decisions based on both symptoms and using biomarkers like fecal calprotectin or CRP, because when you combine both of those and you use the biomarkers, you really can get to higher rates of mucosal healing and fewer flares. So this was considered kind of a pivotal, breakthrough trial in how to manage and how to think about how we should be practicing, because that actually improved long-term outcomes of disease management when we use biomarker driven adjustments.

[00:41:09]

Role of Transmural Healing in CD

Okay, we're going to switch gears. We're in the second category. We're doing pretty good on timing here. So we want to talk a bit about transmural healing. So, as you might remember in the earlier slides, this was like something of a lofty goal on where to get here. And so when we think about mucosal healing, that is really thinking about the intestinal lining that's seen on endoscopy improving. So we use words like ‘endoscopic improvement’, or we may say ‘endoscopic remission’ when everything has totally normalized. And then when we think about transmural healing, we're really thinking about the full thickness normalization of the bowel wall. So what does that mean?

That means on imaging sometimes what you see is inflammation on the outside. And remember, it's really imaging that's going to be able to tell us what's happening on the outside of the bowel wall and all layers thick of the bowel, whereas endoscopy is really only showing us what's happening in the innermost portion, right? So imaging modalities, MRI specifically, CT enterography, MRI enterography or intestinal ultrasound are really the primary tools for assessing transmural healing. So keep that in mind. There may be a question about this later, as you might recall from the pretest.

[00:42:26]

Noninvasive Imaging Modalities

Okay, so how do we go about doing this? Or what are the tools available for us to evaluate this? So 1 of the tests that you might be very familiar with that's been around for a long time is CTE or computed tomography enterography.

So this is a CT scan that is using oral contrast and using IV contrast and really is giving us an idea of being able to look at the bowel wall, right? I always do this, so I'm like Pavlov's dog with that. So I'm sorry if it's kind of a funny thing, but always trying to like, I do that with my patients, like showing them, it's the outside of the bowel wall, you know? So the 1 thing to think about for CT enterography, this is a good study, it's a quick study, patient’s not on the table for a long time. However, there is radiation exposure to this. So for younger patients, this might not be the best option, right? And for evaluating fistulas, the MRIs are a bit more sensitive to being able to evaluate fistulas.

So next comes the middle portion here. This is an MRE or a magnetic resonance enterography. So this is a similar test to a CT enterography. It also uses oral contrast and IV contrast. This can be a little bit difficult for people because depending on how your center's doing it or the local imaging provider that you've got, you know, it's going to depend on like what position people are in. Sometimes the centers like people to be face down. So if they're supine, it can be a little challenging after they just drank a liter and a half, 1.5 liters of contrast, and then you're asking them to lie face down. And then remember, this is a longer test. So the MREs take about 45 minutes to complete if you're just doing MRI enterography, just thinking about abdomen. If you're adding on perianal views, that's about another 15 minutes. So it's like a 45 to 60 minute test where people have drank all that contrast, they're on the table and then they're asked to hold their breath. ‘Don't breathe, hold your breath, okay, breathe now.’ And then you're like doing that in series over and over again. So ask your patient how they feel about that. because It can be really challenging for people and sometimes it’s more traumatizing for people than we might think about.

MRI, you know, your choice of CTE MRE and actually intestinal ultrasound is all going to be highly dependent on what's available at the locations near you, right? Intestinal ultrasound is really gaining a lot of ground in the US. It's been available in Europe for quite some time. There's no radiation required, there's no prep required for that. And there's a strong correlation with endoscopic outcomes in Crohn's disease. So it may be something, if you have that available, it's something that generally a lot of patients see as a value added. It could be a conversation you have right there and then if you're doing the assessment to say, ‘Hey, how is everything going now that we selected a therapy?’ and it can offer and yield a really nice discussion about what to do next.

[00:45:18]

Transmural Healing in CD: Evidence and Challenges

So there's challenges with transmural healing, right? So, we know that transmural healing is correlated with lower rates of surgery, hospitalization. We know that once you get to transmural healing, you have prolonged clinical remission, fewer flares, which is fantastic long-term outcomes. All of this is wonderful. The reality is it can be really challenging to get to this level, right? And so it may be very difficult to get there. We're not always sure that we can with all the therapies we have, but 1 of the keys is this last bullet point on the right hand side.

This is what to pay attention to, because especially if you guys are seeing people who are newly diagnosed, the early initiation of appropriate therapy may make this endpoint more achievable. This is 1 of the most important takeaways of this slide deck, even though it seems like just this tiny little bullet point here, but getting people on appropriate therapy early on in their disease process is key to what's going to happen later on in life, honestly. So it's really important.

[00:46:17]

IUS Comparative Evaluation with Endoscopic Outcomes

We talked a lot about this and, for sake of timing, I'm going to move through, but really what's important to know is that intestinal ultrasound in Crohn's disease has a lot of benefits. It really is going to start supporting the treat to target strategies. But there's some challenges, right?

[00:46:35]

IUS in CD

It's not available in all centers and we really understand that. It's been available in Europe, as I mentioned, for quite some time. And interestingly in the Phase III STARDUST substudy, now that was for ustekinumab, in Europe, they actually looked at intestinal ultrasound and incorporated that endpoint. They had their patients at Week 4 undergo an intestinal ultrasound. And what they found was that patients already at Week 4 when they were showing signs of improvement, their Week 4 response actually predicted Week 48 endoscopic outcomes. So how interesting is that, that at that early Week 4 from their first infusion, if you think about that, right? Four weeks after their first infusion of ustekinumab, that if they were responding, that was going to predict what was going to happen almost a year later. So it's really interesting to kind of think about that.

[00:47:28]

Future Focus

We know 1 of the most challenging things though right now is that there's not a standardized or not fully standardized imaging protocols for intestinal ultrasound. So it's something that really is being thought out. There's a lot of people that are super interested in this. I think you really can't go to a conference anymore without hearing talk about intestinal ultrasound. So I think there's certainly more to come on that, more work to be done. Again, it's not available in all areas, but where it is, it seems to be a really interesting place and opportunity for us to engage with our patients. And I think it does highlight and enhance the shared decision-making process.

[00:48:05]

Patient Cases

Patient Case 1

So this takes us to our, I feel like we should have labeled this patient case 2, because I think in some ways we're talking about Emily and I feel like she's like our most important patient.

So here's another case of another patient. This is James. He's an 18-year-old male. He has abdominal pain, diarrhea, and weight loss, and it's been occurring for 4 months. He underwent a colonoscopy and MRI enterography and he was diagnosed with moderate to severe inflammatory Crohn's disease that affects his ileum and his cecum. There's no stricture, there's no penetrating features.

So what induction therapy would you recommend and how do you monitor the progress toward treatment goals? This is kind of like the idea of how do we put all of this together in the treat to target strategy and where do we go? So induction therapy was recommended with infliximab. He started it. Monotherapy was selected in his case. And the treatment goal that was discussed was really thinking about both symptomatic relief, ‘I want you to feel better,’ and then this other piece, which is, ‘And also I would like things to heal on the inside,’ this is going to help us to reduce the risk of complications in the future.

I will tell you, I talk about this with my patients right from the get go. So I say this, these are our goals and this is the case with any treatment they're going to be on, whether it's a standardized treatment or maybe even a non-standardized treatment. That's not what this is about today, but I'm just going to tell you my approach is the same. This is how I implement it in clinical practice. So having these conversations, I think early on is really helpful because it kind of sets out the roadmap on what we're going to do.

After 8 weeks of therapy, James returns for a follow-up to assess treatment response. He has a reduced stool frequency and less diarrhea, but he's still having persistent abdominal pain. His labs are showing some reduction in CRP and the fecal calprotectin is partly decreased. He had an intestinal ultrasound to monitor the bowel wall thickness and signs of persistent inflammation. Turns out that he still was having inflammation even though there was some improvement. So what about this partial response? What should we do next?

Well, it was recommended then for him to have infliximab level and the antibody to infliximab done at trough to check. Turned out he had a low serum infliximab level, no antibodies to infliximab and so his infliximab was increased to 10 mg/kg every 4 weeks. After 3 infusions at that adjusted dose, his bowel movements normalized. They went back to baseline. He was no longer having abdominal pain and he regained the lost weight that he had had. The CRP and the fecal calprotectin went back into normal range. And he had another intestinal ultrasound, which showed significant improvement, normalization of bowel wall thickness and vascular flow. Does this sound like a dream? Maybe. Maybe it is. But what do we do next?

[00:50:47]

Faculty/Audience Discussion

Well, next is really kind of thinking back on the treat-to-target guidelines. Go back to colonoscopy, go back to MRE to confirm remission. So those are really our best things and those, remember, in his case, he had an abnormal colonoscopy. It showed there was inflammation, he had activity on MRE. So we want to come back to those first diagnostic tools and make sure that we're getting all the way into remission. This is going to help us. And then keep evaluating for ongoing response and remission as well. And then he still needs periodic follow-ups.

It's sometimes very hard to get people to come back in when they're feeling well, but I always like to tell people, ‘I always have stuff to talk with you about.’ I know that sounds crazy if you don't know me, I have tons to talk about with people and I'm thinking there's so much we can do health maintenance-wise that I don't like to do or I can't do when they're actively inflamed. We need to talk about all of that. We need to talk about monitoring of medication.

James also opted to use intestinal ultrasound periodically to continue to monitor remission.

[00:51:46]

Poll 2

Okay, well that is great. So polling question, because we need a little break here. So polling question 2. Do you anticipate incorporating intestinal ultrasound into your practice for monitoring? Or maybe not anticipate, it may also be, do you have it now?

So answer one is no. The next one is no, but we're actively working on implementing it. Or are you considering it for the future? Or were you unfamiliar with this application for this purpose? Do you have it now? Or is it not applicable, especially if you're not in a dedicated GI practice. So thank you so much for voting. We really appreciate that. And we'll keep it open for another couple seconds.

Okay. So, I like all the variety we have here. This is great. Thank you so much everybody.

[00:52:38]

Poll 3

Alright, so polling question number 3. What barriers, if any, do you foresee or have experienced with using intestinal ultrasound in patients with Crohn's disease?

This one is a multiple choice, so you get to check off as many as are applicable in your situation. So none, clinical acceptance, cost, education of providers, lack of availability, patient resistance, or maybe there's another situation that's going on.

And thank you so much to everybody. Okay. Again, a nice smattering of answers and cost and lack of availability, education and I mean, true, right? All of those things. So true.

[00:52:38]

Assessing the Burden of CD with Patient-Centered Communication

Okay, so let's talk about the burden of Crohn's disease with patient-centered communication. This is really kind of coming back to a conversation about, I think in many ways, shared decision-making as Emily brought up. And Emily will be joining us shortly. So she's welcome to come in at any time, because it was really interesting, we'd love to hear her insights on bowel urgency and thinking about what this is. I'll just kind of paint the picture while Emily's coming back on.

[00:53:55]

Bowel Urgency in CD

So thinking about we define bowel urgency as an urgent or uncontrollable need to defecate with little or no warning. The etiology of this can be vast. There could be different parts of this. There could be active inflammation because of Crohn's disease. There could be dysregulation of the gut motility and nerve signaling. Sometimes it's secondary to dietary triggers, but there also could be inflammation that leads to scarring, fibrosis, or medication side effects. And it's incredibly common. So 50% to 70% of people with Crohn's disease, especially during active disease phases, but it can persist even after that. And Emily jump in here if you'd like to share your experience with this, wow we should talk with patients about this.

[00:54:39]

BU in IBD: Prevalence, Impact and Clinical Challenges

You know, I think we can kind of skip through like the prevalence and quality of life, because I think you are the best person to tell us about what this looks like and all the impact.

[00:54:51]

Patient- and Physician-Reported Symptoms Greatly Impacting QoL

And actually maybe you should comment on this slide because I think when I first saw this slide – and I know again, I'm springing this on her, I'm not sure you've totally seen this one before – but I found this super fascinating when I first saw it, that there was a total disconnect between patients and in this situation physicians. And it was just was a survey asking patients and asking physicians like, tell us what percent of this is impacting people's lives as a high impact on patients' lives. And this discrepancy on the left hand side of rectal urgency in Crohn's disease was really astonishing. Like if you see patients, 65% of patients said they are experiencing rectal urgency as really impacting their quality of life. And physicians only thought this maybe less than a third of the time. And I found this really interesting because most of the other ones like kind of correlate, like abdominal pain kind of looks similar, fatigue kind of looks similar, diarrhea need for toileting after eating, you know, weight loss. What do you think about this?

Emily Bennett: I find this very fascinating. So I will say, so my experiences with bowel urgency are sort of 2-fold because in 2013 I had surgery to remove some of my like damaged and diseased colon, and so the large intestine and the small intestine. And part of that was actually removing my ileocecal valve as well. And so that also kind of put me in a unique position dealing with bowel urgency and stuff like that. For people that don't know, I mean, I'm sure you all know, but that kind of regulates some of the flow of stuff.

Angelina Collins: Absolutely. Yeah.

Emily Bennett: And so yeah, so losing that, you know, was kind of a big deal.

Angelina Collins: Yeah.

Emily Bennett: I am fascinated. As I said earlier, so my second provider that I work with now and have been for many, many years, I think he knows very well my day to day – well, I think he knows that it's a problem for me, but maybe he doesn't know that it's quite like, not necessarily day to day, but it's certainly something that I do have to be aware of. And I would say that we have a really great relationship and yet even then, like he probably doesn't quite know that it is something that I have to be like very mindful of.

When we were first talking before our presentation here, you know, you mentioned how a lot of Crohn's patients, we find we immediately walk in somewhere and we find the bathroom. And that it really weighs in to like, and I think even as somebody who lives with Crohn's, like, you know, every single day, I think looking at this, I'm like, oh yeah, I guess it actually does impact my day to day. And it just kind of becomes so second nature to you that you don't realize, ‘Oh, there are people out there that don't weigh whether or not they're going to go somewhere. Because last time I was there, there was a really long line for the bathroom because it was only a 2 seater. And that's not going to cut it.’

Angelina Collins: So that's a great point, right? Like how much it impacts your life or maybe where you want to go, or like, ‘Maybe we should go to dinner somewhere else, you guys.’ You know, it's interesting, right? Because you're right, you probably, this is now incorporated into your life. You are experiencing it and this has become very normal for you or that it's a normal feeling that you might have. And so how can you be successful in your outings, right?

[00:58:52]

Psychosocial and Functional Impacts of BU

Emily Bennett: Yeah. Yeah. Oh yeah. And it's, you know, my wife of course is very understanding and things like that. You know, we've been together for like over 10 years now, but, you know, even then, when you're out on like a date or something like that, it's something awkward to kind of have to deal with, you know, when you're like, ‘Hi, excuse me, sorry, I'm just looking for my own emergency exit.’ So.

Angelina Collins: Yeah. Yeah, it's a great point. And I think like some of the studies that have been done, have looked at this and have like really relied on people, so open and honest as you are and as you've been, is like really thinking, this impacts every single part of people's life, right? Like you just mentioned now how it can impact your family relationships or, you know, love life, and obviously dating scenario, right? And for some people they're like missing work because of it. And do you think, did it have an impact on your mental health at all at any point? And now if you're comfortable sharing your experiencing from that perspective.

Emily Bennett: Oh, absolutely. You know, I feel really lucky that I'm at a point now in my life where I can kind of just laugh about it. You know, I always joke with my wife, like, when I'm packing for a trip, I pack like, you know, x, y, z extra number of pairs of underwear, you know, just in case. Because sometimes stuff happens.

Angelina Collins: Yeah.

Emily Bennett: But yeah, especially, especially as a young person, like I spoke about at the beginning, it's a really awkward thing, especially when you're young. You know, trying to explain to people kind of what you're dealing with, you wind up just not wanting to talk about it at all. And as I'm sure you can understand, kind of living with that almost like silent shame, it really impacts you. You know, you suddenly feel like you have this dirty secret that you're trying to keep from people. And you know, it's why I'm so happy to appear like here and talk about my experience because I hope that it means that these kind of things, like you said earlier, kind of get normalized and it just kind of becomes a part of your daily life.

But you know, prior to that, yeah, no, absolutely. It definitely weighed on me, impacted me, stressed me out, you know, made me make a lot of decisions about my life based on how close I was to a toilet, which once you like admit that to yourself, you know, it's a really hard thing to deal with. So

Angelina Collins: Yeah, I can appreciate how challenging it is and yet how many other people with Crohn's, most people are living with symptoms of urgency, right? And maybe as providers, like we're just really not doing a good job of always asking. And I think that was 1 big thing too, is that it's easier if we as providers ask and maybe just find a good way to ask the question of, ‘Hey, I was talking with other patients with Crohn's and they sometimes, you know, have difficulty making it to the bathroom on time. Is that something that's affecting you?’ You know, finding a way in which to say it that does normalize that other people experience this. But yet if we're not asking, we don't know what's happening with the people that we're trying to help, right? I mean, I just think that we have to ask, it needs to be on us. I don't think we can wait for people to bring it up to us.

Emily Bennett: Yeah, I know that I personally, even as comfortable as I am now, it's definitely something that I would probably struggle to bring up with my provider, whom I trust and, you know, we have a good working relationship. But again, it's not something that you immediately want to volunteer because I'm sure there's a lot of people out there that think like, oh, well, you know, this is just a part of Crohn's disease and you know, I shouldn't talk about it and I'll just kind of deal with it on my own. And, you know, knowing that your provider is concerned about that and wants to improve that part of, you know, your life and your symptoms and what you're dealing with, I think would probably go a really long way to sort of like, you know, bridging the gap and really building that trust.

[01:03:28]

Survey and Online Focus Group

Highlighted Survey Data

Angelina Collins: Yeah, I think that makes a really great point because there's other parts in the slide deck about, you know, how in surveys that are done, how it's impacting all of these different things.

[01:03:38]

Key Takeaways for Providers

For sake of time and interest of time and being able to get some to some questions, I thought 1 thing was really highlighted very well.

[01:03:45]

Focus Group

Focus Group Takeaways

That was part of this focus group that I wanted to bring up, is that people often didn't have a lot of confidence that the medication they were going to go on was actually going to help with bowel urgency. And I think that's an interesting point and an interesting place to make.

[01:04:05]

Patient Engagement and Empowerment

But I think the conversation starts with us and at least addressing the problem to know and to identify how significant of a problem it is, and then to come up with solutions, right? And I think that's a really important part of it, and I thank you for sharing all of that. because I know that your willingness to talk about this is just so important and it's really fantastic because, you know, not everyone's comfortable just kind of, you know, being honest about some of these things. And yet we know from numbers that there's so many people suffering and probably suffering silently as you've well pointed out, very elegantly.

Emily Bennett: My pleasure. My pleasure. Like I said, and you know, it's all about just normalizing it and you know, approaching it empathetically like, you know, taking away the stigma, taking away the shame, and just being like, Hey, this is something that you're living with and it's probably really impacting you, your life, your mental health. And you know, just again, that partnership of what can we do together to, you know, just improve, improve what you're dealing with.

Angelina Collins: Nobody needs me anymore. You've said it all. I mean, this is like mic drop, like there we are. Done. Thank you. You've wrapped it up so perfectly. So, that was fantastic and actually it's funny because as you're talking, I'm like, oh yeah, that's basically like, you know, these ideas on how to handle it. I'm like, yep, you nailed it. So thank you for that. I know, you're so wonderful. You're always super insightful in how you think about this and how you're really using your experiences to really help us better what we can possibly do, and I’m really appreciative of that. So thank you so much.

Emily Bennett: Well, it's, again, as always, it's my absolute pleasure. Thank you so much for this dialogue, Angelina, it's always a pleasure to speak with you about this.

Angelina Collins: Thank you so much.

[01:05:56]

Strategies for Proactively Addressing BU

I know that there's some questions waiting for me to answer and some post-test questions. Emily, you're welcome to stay on, you're welcome to scooch off, whatever works for you. So, you may feel better to just take a break and have a glass of water or something, so feel free. Thank you.

So we kind of talked about a lot of these, you know, shared decision-making tools. You know, really kind of normalizing the conversation and I think Emily just really summed it up really wonderfully.

[01:06:28]

Patient Case 2

So there's a patient case that kind of is similar, but I feel like Emily was so great on this and for the sake of the conversation, you know, I think there's some phases here that we’ll kind of jump to.

[01:06:39]

Collaboration to Help Sarah

But 1 is about the shared decision-making. Asking our patients upright, proposing an initial plan, thinking about maybe symptom tracking or trying to understand if there's some triggers or things that we can do. Addressing barriers, you know, patient concerns, putting it into their perspective on what we can do and how to really overcome this conversation that's like, you know, somebody thinking they're in this by themselves, which is often what they're feeling.

[01:07:04]

Collaboration to Help Sarah, cont.

And then how do we collaborate? You know, what are we going to think about doing? It's not just about trying to decrease inflammation, which will probably be helpful, right, but how helpful that's going to be. And then we have to really think about how do we move forward. And maybe in a lot of cases, like finding a support group, you know. I use a lot of the Crohn's and Colitis Foundation. I shamelessly will plug them in many ways. You know, I've been actively involved and there's likely probably a chapter near you where you can even direct patients to, or there's online forums, there's online community support and that can be really helpful for our patients.

[01:07:40]

Summary: Key Takeaways

So as we wrap up, I really want to thank everybody. Please do add in. If you have questions, please ask questions in the Q&A box, that would be wonderful. I'm happy to answer them.

Today we really kind of focused on the treat-to-target goals. You know, thinking not just about symptom remission, but going beyond that to mucosal healing, improved quality of life long-term and using biomarkers and imaging, driving strategies to optimize care.

Thinking about all the different therapies that are available. Using not just endoscopic healing, but thinking about if we're going to be able to get to transmural healing as another endpoint to reduce hospitalizations and surgeries.

And really, we focused a lot on patient-centered care and thankfully with Emily being here to help guide us through that process and thinking about how do we engage with our patients, how do we provide better care to them? How do we have these difficult conversations maybe a little easier?

And then the future. We have some ideas for next steps that we might be thinking about as well.

[01:08:37]

Post-Test

Post-test 1

So before everybody leaves, I have left no less than 3 minutes time to do the post-test. So again, I want to really thank everybody. So post-test question number one is, there's a 42-year-old patient with moderate to severe Crohn's disease on biologic therapy who reports mild symptoms but has elevated CRP and imaging is showing intestinal inflammation. Which approach best aligns with the treat-to-target strategy for evaluating treatment response and guiding therapy?

The first is to escalate treatment based on persistent inflammation and follow up with biomarker testing, imaging and clinical assessment to evaluate if targets are met.

Lower medication dosage to minimize side effects given the mild symptoms.

Monitor symptoms since they're mild, and increase medication dose if symptoms worsen.

Or the last option is to use long-term steroid therapy to manage inflammation while maintaining the current regimen. Took me a while to say all of those things, so please select your best choice.

And then the great thing is with this, now that we're in the post-test, so now we can see how everyone votes. So thank you everyone for voting. Now let's see the choices.

So here was the answer. So the rationale is to escalate treatment based on persistent inflammation and follow up with biomarker testing, imaging and clinical assessment to evaluate if the targets are met. So really we're thinking about using the treat-to-target strategy, and that's going to emphasize really the goals of getting people into mucosal healing, normalization of biomarkers, and using those in conjunction with symptoms, you know, to really get to the best treatment outcomes. So in this case, the best option would be to escalate to get them to their end goals.

[01:10:21]

Post-test 2

So post-test question number two. A 34-year-old patient with Crohn's disease presents for evaluation of disease activity. The healthcare provider wants to assess both mucosal and transmural inflammation using a non-invasive imaging. Which of the following would be appropriate?

Abdominal X-ray; capsule endoscopy; magnetic resonance enterography or MRE; or sigmoidoscopy?

Thank you for making your selection. And we're going to see the responses and then we'll be able to show you the rationale. All right, good job, everybody. MRE, and guess what, that is the correct answer. So remember the MRE is able to see the outside of the bowel wall as well as really getting a good idea on what's happening transmurally. The capsule endoscopy and sigmoidoscopy are both looking at just what's happening in the lumen and abdominal X-ray is really not able to show the layers of the bowel wall.

[01:11:23]

Post-test 3

Okay, last post-test question. A 28-Year-Old patient with Crohn's disease appears to be hesitant during the clinic visit where the healthcare provider wants to discuss bowel urgency to better understand the patient's disease burden. Which communication strategy is most effective to engage and empower the patient to share?

So option one is directly inquire about specific symptoms like bowel urgency in a factual manner to keep the discussion focused and efficient. The next option, allow the patient to guide the conversation and bring up concerns naturally when they feel ready. Or open the discussion with general empathetic questions and normalize the conversation about symptoms like bowel urgency to reduce discomfort. Or the last option is provide detailed explanations of symptom related medical terms to ensure the patient fully understands their condition before discussing their experience.

And thank you to everyone for voting. Okay, so 92%, I think this is what we were kind of hoping for in this situation. Because we're really realizing, I fully understand like where, you know, allowing the patient to guide the conversation and bring up the concerns naturally when they feel ready. But I think in general terms, our patients are really waiting for us to bring it up with them. And some people actually aren't bringing up the conversation because they think we're the ones, as providers, we're the ones that would be asking if we thought it was important. So using open ended question, focusing on empathetic communication can kind of normalize this really sometimes very awkward conversation for people. And oftentimes, like I said before, I'll often say, Other people…’ you know, I may share a story or I may say, ‘I've had other people that have this concern, is that something that we should be thinking about in your case?’ Or something along those lines that would work well for you?

[01:13:08]

Q&A

So I really want to take the time to thank everybody for coming to the presentation today. I'm going to go to the next one as I'm going through.

[01:13:20]

Go Online for More PCE Coverage of CD!

You can again look at the resources tab and there is a downloadable slide deck, so we thank you for that. There's also going to be more coming from PCE coverage for Crohn's disease, so there'll be more coming soon. You can go to practicingclinicians.com. We did a clinical thought expert commentary with smart patient data that Dr Sans and I did, and you have that available with some key commentary on all the studies that have occurred.

[01:13:50]

To claim credit

And then also you can claim your credit with this link here as well, or you can take a screenshot of this, so if you go to practicingclinicians.com. And again, I want to thank everybody. And I thought there was a – my apologies, I went too far. I thought there was a QR code. So I will apologize.

[01:14:11]

Question Received

So, the question that came in, and I thank you Suzanne for asking this question, age at diagnosis depends on how old you are. ‘I had severe symptoms for 30 to 40 years before the diagnosis. I'm 68 years now and with a diagnosis in 2020. How does that affect my high or low risk factors?’

So the age at diagnosis is the age you were when you were diagnosed. However, in this case, this is a really interesting point. So if symptoms really started 30 to 40 years before diagnosis, oftentimes people will use that, especially if they were severe symptoms and they're the same symptoms that they had ongoing until the time of diagnosis. Oftentimes people will use the age of onset of symptoms probably as the most likely point of when the diagnosis probably actually occurred, if it seems to correlate really well.

So, it depends, there's a lot of different factors here, but that would be the answer I would give you how I would handle it in my clinical scenario. I probably wouldn't adhere quite to the 2020 diagnosis. It sounds like there's been significant ongoing symptoms for years prior. So that's probably how I would answer this particular one. However, it's always tough when we talk about this and there's a patient on the other end. I always think, you know, something to talk about with your provider and have that conversation about it and something to really kind of think about. So I appreciate the question very much and I'm sure your provider will as well. And I think that will give you the best sense of care is to have that conversation and ask.