- From the American Association of Nurse Practitioners, this is Cammie Hauser, nurse practitioner, nurse midwife, and AANP education specialist. Welcome to this edition of NP Pulse, the voice of the nurse practitioner, AANP’s official podcast, bringing unique nurse practitioner voices and expertise on issues that matter most to NPs and to our patients.
As always, be sure to subscribe to this podcast, share with your colleagues, and check back often for new conversations with nurse practitioners and healthcare leaders from across the nation. In this episode of NP Pulse, nurse practitioners, Jessica Crimaldi and Christina Hanson explore the evolving landscape of ulcerative colitis, a chronic inflammatory bowel disease affecting over a
million Americans. With decades of GI experience, Jessica and Christina break down the burden of UC on patient's physical and psychosocial wellbeing, review distinguishing features from Crohn's Disease and examine the increasing prevalence tied to lifestyle and environmental factors.
This important conversation dives into the era of precision medicine, highlighting a new generation of targeted therapies, updated clinical guidelines, and best practices for early diagnosis, management and shared decision making.
From understanding disease severity and medication classes to addressing extraintestinal manifestations, cancer screening, and vaccination recommendations, this episode is a must listen for NPs striving to provide optimal up-to-date care for patients with ulcerative colitis. - Hello, welcome to the podcast on shared decision making amid an evolution of novel therapies for ulcerative colitis or UC. My name is Jessica Crimaldi.
I'm a nurse practitioner at Cleveland Clinic working in gastroenterology and hepatology, and today I'm joined by my esteemed colleague Christina Hansen, who is also a nurse practitioner. I'll let Christina tell you a little bit about herself. - Thanks Jessica. Yes, again, Christina Hanson, nurse practitioner and I've been working in GI and hepatology at South Denver GI for a little over 18 years.
We're gonna start by talking about the changes we've seen in ulcerative colitis in terms of prevalence, patient burden, pathophysiologic drivers, and the dawning era of precision medicine. We are going to start by talking about the changes we've seen in ulcerative colitis in terms of prevalence, patient burden, pathophysiologic drivers, and the dawning era of precision medicine.
But before we get started in our focus on UC, let's take a brief minute to review a few factors that differentiate ulcerative colitis from Crohn's disease, another inflammatory bowel disease.
First, when we talk about location, ulcerative colitis is really confined to the large intestine, the large colon, whereas Crohn's can impact any part of the digestive tract from tip to tail if you will, but often affects the terminal ileum where the small bowel joins the large colon and the perirectal area. Upper GI Crohn's while possible is quite rare and I can probably count on one hand the amount of patients I've had with upper GI Crohn's over the last 20 years.
And then when we look at the inflammatory pattern, ulcerative colitis typically manifests as continuous inflammation throughout the large intestine and inflammation generally limited to the mucosal lining of the colon, whereas Crohn's can manifest in a patchwork pattern or skip lesions, which is very distinct on a colonoscopy with healthy regions of the digestive track interspersed with diseased regions.
Crohn's inflammation can affect all layers of the bowel wall and can lead to fistulas and stricturing disease. And then when we look at UC in terms of epidemiologic considerations, we recognize that the incidents and prevalence trends are both increasing.
Global UC burden now exceeds 5 million patients. Specific to the US over one and a quarter million Americans are currently impacted by UC and prevalence and incidents are rising in the general population as well as expanding in both younger and older demographics. Jessica, why do you think the incidents is increasing? - That's a great question, Christina. We believe that IBD incidents is increasing due to the western lifestyle as well as environmental factors.
Interestingly, research has shown that countries or areas that previously had low incidents of IBD who became more industrialized or more westernized over time also start to develop a higher incidence of IBD. We think there is a strong relationship directly tied to our environment and way of life. - We recognize that UC and IBD in general has an extreme burden on patient's quality of life given the nature of the disease and symptoms.
UC is associated with significant decrements in health related quality of life, which are driven by its heterogeneous hallmark of disease manifestations. Some of the cardinal features of UC precipitating the core burden of illness include bowel frequency and urgency that our patients experience this term called tenesmus, which we in GI call rectal retching. A patient has this feeling of constant urge to have a bowel movement even if the bowel is empty.
And this is often seen in ulcerative proctitis where that inflammation is really limited to the rectal area and Jessica can probably agree with this. It's very burdensome on our patients. They have abdominal pain, diarrhea and rectal bleeding, even incontinence and fatigue, which is often a consequent of GI blood loss or anemia. And if you take all these together, obviously dramatically impacts our patient's quality of life and really their activities of daily living.
Now how about the psychosocial gravity of UC? We certainly see issues with patients having increases in anxiety, depression, suicide, and impaired social functioning. Jessica, which elements of UC are most detrimental to patient reported outcomes or PROs? Have you encountered patients with UC associated psychosocial burdens?
- Of course, Christina, in my experience, abdominal pain and bowel frequency or diarrhea as you mentioned, are the most bothersome, especially to patients who are not able to be home during the day, such as those who might be in college or graduate school or working. There's a lot of anxiety surrounding the possibility of accidents, embarrassment about frequent need to use the bathroom on top of not feeling well in general or having abdominal pain.
It is very common for patients with IBD to have concomitant psychosocial concerns. Most commonly we see anxiety and depression, which are often intertwined with their symptoms and stress during times of increased disease activity. These symptoms can flare as well, making them more depressed, more anxious. Sometimes they become more reclusive as well, not wanting to leave their house or be in social situations.
It's important in this population to screen for psychosocial concerns and there are a few tools to do that and refer when you feel it's appropriate. - Yeah, I think you would agree, Jessica. This is probably the patient population that we see a lot of absenteeism from work. They'll skip social interactions and a lot of times are the population of patients that I see that are asking for some kind of work exception or FMLA just because of the burden of their symptoms.
So how do you approach your patients with IBD and when discussing their signs and symptoms and what they're having to deal with on all levels of quality of life when it comes to their disease burden? - I try to be as empathetic as possible. It's very hard for some of these patients to even talk to you about these things because of embarrassment or because of stigma around some of their symptoms.
So trying to be empathetic and just letting them know, you know, this is what I do all day, these talks are perfectly normal to me. I know they're uncomfortable for you but we're here to help.
And then also kind of weaving in education on how the treatment options or recommendations we give them will hopefully improve their symptoms as well as decreasing their inflammation which meets the overall goal of, you know, stopping to go to the bathroom less often and less abdominal pain and hopefully improving their quality of life. - Yeah, I think it's really important, as you said, just to make it a comfortable space to talk about.
You and I are are used to talking about this all day long and I try to, you know, emphasize that to my patient, you know, don't hold back the, the more detail the better in whatever way that it feels comfortable for them to explain it. It's gonna help me be able to take care of you the best. So I, I definitely want these patients to feel comfortable with talking about these types of symptoms.
Another important factor involved in the complexity of UC, and again IBD in general is that of extraintestinal manifestations or EIMs. So extraintestinal manifestation prevalence can be anywhere from 25 to 40% across all cases of IBD and then specific to ulcerative colitis, 27% of patients have extraintestinal manifestations involving multiple organ systems.
So it's important for us to be asking our patients not only about the colonic, the digestive symptoms, the GI symptoms, but also any other types of extraintestinal manifestation. So we can see upwards of 30% of involvement in joints and this is probably one of the most common that I tend to see is patients describing, you know, almost like arthritic type of joint pain, dermatologic skin rashes and lesions up to 20%, bone involvement, 30 to 60%, uveitis or or eyes.
So 10%. So making sure we're talking to our patients our, do they have they had an updated eye exam. Liver and kidney can be a rare organ involvement but is possible a lot of our patients will have anemia and and often notably related to that GI blood loss. Again leading to that fatigue these patients can experience.
We're gonna talk a little bit more about extraintestinal manifestations a little later in the podcast and how primary care providers can be more aware of these and management they're in. But despite the complexity and burden of the disease along with the growing prevalence and incidents we have in recent years developed multiple new treatments for this disease space allowing us to utilize this idea of precision medicine with novel targeted treatments.
So Jessica, can you take us through a discussion on foundations in precision medicine and speak a bit more to these new novel targeted treatments we currently have available? - Absolutely. First, let's define precision medicine for IBD.
Precision medicine refers to the process of classifying patients into subgroups based on similar clinical and molecular characteristics with the ultimate goal of tailoring interventions to each group that would most accurately treat their disease with the least amount of side effects. This has been done for many years in oncology but is relatively new to the IBD field.
We know in IBD there are many different inflammatory pathways that can lead to bowel inflammation and in an ideal world we would be able to give each patient the medication that most specifically works to their inflammatory pathway but we are not yet there in clinical practice.
To give a relatable example, when you're treating a patient for a UTI, we typically review the urine culture and sensitivity data and prescribe the antibiotic that is most likely to work on the specific bacteria based on the sensitivities. This allows us to precisely pick a medication that has a high likelihood of working and avoid trialing other medications that are less effective unnecessarily.
There is no test like this for IBD and we continue to have a population that is sub-optimally treated for several reasons, including primary non-response. This refers to when you give a medication and it just never works for that patient. Loss of response, this refers to when the patient has been taking the medication and it's been working over a period of time but then it loses its effect. That can be for a number of reasons or just an intolerance to the medication.
Sometimes the side effects are too large for patients to continue on with a specific therapy. The novel therapies in IBD that we will talk about today are targeting new inflammatory pathways that drive disease activity and progression.
When thinking about the new medications for IBD, they are largely but not all in the biologic space and include the following targets, tumor necrosis factor or TNF, the JAK/STAT pathway, interleukin 12 and interleukin 23 or IL-12, IL-23 cytokine cascade, the Alpha-4/Beta-7 integrin signaling and the sphingosine-1-phosphate receptor modulation. With all the new medications it can be challenging to keep up with the most recent data and treatment algorithms.
We are fortunate to have two large GI societies, the American College of Gastroenterology or ACG and the American Gastroenterology Association or AGA that both have guidelines on the management of UC. Not surprisingly, with the rapid growth in treatment options, the guidelines quickly become outdated prompting the AGA to shift their approach to providing up-to-date information. Christina, can you compare and contrast the AGA and a CG guidelines for UC and the recent updates?
- So both the AGA - So both the AGA and the ACG provide clinical practice guidelines for inflammatory bowel disease, but there definitely are some key differences in their approach. The AGA and ACG largely share a similar goal improving IBD outcomes through evidence-based practice, but they may differ in their specific recommendations for treatment and management, particularly in the early stages of moderate to severe UC.
The most recent AGA guidelines on ulcerative colitis was actually just published in November of 2024 in Gastroenterology, and is termed as a living guideline, which is focusing on the pharmacological management of moderate to severe UC. And actually we'll be updated every six months and obviously as you were mentioning Jessica, we really need this with all these incredibly fantastic new novel agents.
This living document is meant to be reviewed and updated regularly based on new evidence and emerging treatments with the goal of providing the most current recommendations for managing ulcerative colitis. This updated guideline recommends earlier use of more effective drugs including biologics and small molecule therapies instead of a step up approach with five amino salicylates, which we've historically done.
Additionally, there's a new guideline on monitoring ulcerative colitis with non-invasive biomarkers and this was actually published in February of 2023. So we do have some updated guidelines and recommendations from what we've had thus far, especially because of, as Jessica mentioned, this wave of new therapies that have been improved.
Colorectal cancer screening, both societies actually recommend colonoscopies for those IBD patients with longstanding disease and involvement of a large portion of the colon and both utilize evidence-based approaches to develop their guidelines drawing on clinical trials and expert opinions.
While both organizations provide valuable guidance for IBD management, the AGA's guidelines are more comprehensive and may lean towards a more proactive early use of advanced therapies in selected IBD cases, particularly for moderate to severe UC as I mentioned earlier. While the ACG guidelines are actually more focused on the specific aspects of UC care including hospitalized patients
and colorectal cancer prevention. Jessica, the arrival of these disease modifying therapeutics or DMTs places heightened awareness on the need for timely diagnosis and linkage to treatment within the disease's natural history or what we call this window of opportunity. What is this term window of opportunity? The window of opportunity in IBD refers to the time early in the disease course when medications may be the most effective in treating and reducing inflammation.
We know that IBD is a lifelong and progressive disease and there is often a delay in diagnoses. Greater than 50% of patients have symptoms for at least a year before obtaining a formal diagnosis. While 25% have symptoms for greater than five years, diagnostic delays lead to treatment delays
and to detrimental outcomes. While treatment is delayed, patients have ongoing inflammation or what some people refer to as smoldering inflammation that over time can lead to fibrosis, strictures, penetrating disease and even malignancy. Treating as early as possible helps to quiet the inflammation before it can progress to more serious complications.
Christina, what do you think are some of the main drivers of the ulcerative colitis diagnostic delay and how can patient facing clinicians help combat these hurdles to achieve timely diagnosis and treatment linkage?
- Well yeah Jessica, I think there are certainly many factors leading to delay of diagnosis, including sometimes the non-specific nature of symptoms which can be mistaken for other diseases or conditions such as irritable bowel syndrome, hemorrhoids for rectal bleeding or simply a lack of knowledge around UC and its associated symptoms which again can lead to further delay.
Patients can often learn to live with their own norm and I talk to my patients with IBD about this, you know they've been living with these symptoms for a long time, maybe there's not prolific rectal bleeding that prompts them to seek more emergent medical care and they just kind of think it's their norm and so they don't pursue medical care for a long period of time or sometimes they can have a lot of embarrassment as you mentioned earlier, over the type of symptoms they're experiencing.
Again, leading to delay or sometimes they simply fear their symptoms and potential diagnosis. We can also find limitations in access to care with long wait times to get into see a GI specialist and in addition, lack of specific and reliable diagnostic tools for UC. Obviously if they're not undergoing a colonoscopy immediately, which can make it difficult to differentiate from other conditions leading to diagnostic delays.
In addition, approximately 25 to 40% of individuals with IBD display extra intestinal manifestations as I mentioned earlier, and the range of presenting symptoms with these EIMs can make it challenging for clinicians to promptly identify patients with IBD. Symptoms can be attributed to other conditions such as IBS as I mentioned, all again, which can lead to these delays and some data suggests a range of delay up to eight years or longer. Now how do we combat these hurdles?
Well, I think having a strong baseline knowledge around IBD including the signs and symptoms, typical ages at presentation and potentially genetic predisposition so that when you're talking to a patient presenting with perhaps not extremely clear symptoms, warranting referrals such as that really excessive bloody diarrhea, then the healthcare provider will have a lower threshold to ask further questions around these factors.
I think continued development of validated diagnostic tools with high sensitivity and specificity will also be helpful for clinicians in the primary care setting tools such as that fecal calprotectin, which we're now using a lot at baseline when we have a high suspicion for IBD and to monitor treatment response or when patients might be flaring.
And as we improve diagnostic delay, we will then be able to get more patients in during that window of opportunity where early intervention, using more aggressive and therapeutic agents certainly can lead to better long-term outcomes, potentially even modifying the disease's natural progression and we truly are armed with an exceptional range of novel targeted therapies than we ever had before in our armamentarium.
So Jessica, would you take us through a general overview of our current arsenal and how these treatments are unique from therapies in the past? - Thanks Christina. I think it's very fitting that we're doing this talk in 2025 when 20 years ago this year the first biologic for UC was FDA approved. That was Infliximab, which many of us in GI are very familiar with. Since that time we've had an additional 11 medications approved and we will talk about some of the most recent ones now.
Please note this discussion is not an all-inclusive list of medications. There are a whole slew of medications for more mild disease and many medications that come in different forms such as rectal suppositories, foams, pills, and other medications that are adjunct to treatments. Today we're taking a focused look at some of the more recent novel medications but not all of the medications for UC. So first up on our list are the novel practice changing class in UC, the JAK inhibitors.
Why do I say it's a practice changing class? So this class was the very first one to offer a pill prior to the JAK inhibitors, we could say stronger medications for ulcerative colitis were in an IV or subq injection form. So having a pill was really game changing. There are currently two available JAK inhibitors, Tofacitinib and Upadacitinib. JAKs are enzymes or proteins that travel to specific surface receptors
on our immune cells. They help to signal a messenger chemical called STAT to tell the nucleus to promote inflammation. When you take a JAK inhibitor, you block some of that action. Like I said, JAK inhibitors were a game changer because they were the first oral pills, not injections or infusions, they were cheaper to manufacture. They work very quickly and are less likely to cause the development of antibodies
or an immune reaction. If you're familiar with Remicade or Infliximab for example, this medication over time patients can develop antibodies where it no longer works for them or they can also have an allergic reaction or an immune reaction. When that happens, that medication is no longer available to them as a treatment option. So having a medication that is less likely to cause antibodies or an immune reaction is also a huge plus side.
Side effects of JAK inhibitors do include an increased risk of shingles, elevated cholesterol and blood clots such as PE and DVT and cardiac events such as MIs and cancer. Just to overview the two, again, Tofacitinib was first FDA approved for UC in 2018, so we're about seven years. It was evaluated in the OCTAVE clinical trial program. There was OCTAVE 1 and OCTAVE 2 which looked at induction and OCTAVE Sustain which looked at remission.
In the induction studies participants receiving Tofacitinib experienced a 16 to 18% level of induction compared to placebo at 6 to 8%. In the SUSTAIN trial, which looked at long-term remission participants receiving Tofacitinib had remission rates as high as 34 to 40% compared to just 11% in the control group. Those are pretty big numbers in IBD data.
The second drug Upadacitinib is the second JAK and that was FDA approved for ulcerative colitis in 2022 after being found to be more efficacious than placebo during induction. The next new class of drugs is the Anti-IL-12/IL-23 monoclonal antibodies. IL stands for interleukin and IL-12 and 23 are pro-inflammatory cytokines that play a role in inducing and maintaining intestinal inflammation by actively recruiting white blood cells to the bowel.
There is one medication approved for UC in this class, Ustekinumab. Ustekinumab was approved in 2019. The first dose is given as an IV infusion so this would require the patient to go to an infusion center or in some areas you may be able to get an at-home infusion and then that's followed by periodic subcutaneous injections.
This can make this a more convenient option than strictly IV infusions for patients, but we do have to think about if our patients are willing to self-inject or if they have someone who is willing to inject them. Adverse events with this medication were mild and did not appear to differ from those within the placebo group. So to review Ustekinumab blocks both the IL -2 and IL-23 signaling pathways to reduce inflammation.
It was evaluated and then the UNIFI trial and FDA approved for ulcerative colitis in 2019. In addition to the combined anti IL-12 and anti IL-23 combination drug Ustekinumab, there are medications that target IL-23 alone and those include Mirikizumab, Risankizumab, and Guselkumab. If you can say all those without getting tongue tied, you're better off than I am. They were all evaluated in various clinical trials and Mirikizumab was approved in 2023 Risankizumab in 2024 and Guselkumab in 2024.
Guselkumab had a recent release of positive data from phase three ASTRO study that laid the groundwork for the potential approval of a subcutaneous injection regimen as well. That would make Guselkumab the only anti IL-23 monoclonal antibody that is available for subq injection. Lastly, on the IL-23 pathway we have one drug that has recently completed a phase two B study
and that is Icotrockinra. Johnson and Johnson announced just about a month ago on March 10th, 2025 positive top line results from ANTHEM-UC, a phase two B study of Icotrockinra, the first investigational targeted oral peptide that selectively blocks the IL-23 receptors in adults with moderately to severe ulcerative colitis. Though this is a pill form of the anti IL-23 pathway drugs, this would also be a first in this class.
The study met its primary endpoint of clinical response in all Icotrockinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of remission, symptomatic remission and endoscopic improvement, Week 12. It was well tolerated with proportions of participants reporting one or more adverse events being similar between the placebo and the treatment group.
The date for it to be FDA approved is not currently available yet as the data from this study is currently being prepared for upcoming medical congresses. Moving on to our fourth class, we have the Alpha-4/ Beta-7 integrin inhibitors which work by blocking white blood cells from attaching to tissue and prevent them from entering the lining of the GI tract and causing inflammation.
We have one medication in this class Vedolizumab, which was FDA approved initially back in 2014 for the IV route and more recently in 2023 for the subcutaneous route which is great for our patients giving them another option. Vedolizumab is considered to be a gut directed medication and does not cause systemic immune suppression which leads to increased safety and tolerability.
I can tell you from personal experience a lot of patients want to take this medication or may have read about it before their appointment or before meeting with you because they do advertise it as being more specific and patients really like that it doesn't cause systemic immune suppression like some of the other medications. We do have newer ones that are adding that benefit as well. But with this having been approved in 2014, it was the only one around for a while.
And lastly we have the S1P receptor modulators, which stands for sphingosine-1-phosphate receptor modulations and agonists, which include Ozanimod, which was approved in 2021 and Estrasimod approved in 2023. Both medications are available as an oral pill or tablet. S1P receptor modulators bind to receptors found on the surface of immune cells.
By binding they prevent the immune cells from being released into the bloodstream which reduces the amount of inflammation in patients who have ulcerative colitis. Side effects include a decreased white blood cell count, so a baseline level and ongoing monitoring are needed as well as elevated liver biochemistries. So this would be your AST, ALT, TBILI alk phos potentially, decreased heart rate, infections, increased blood pressure, eye problem, and herpes infection.
Patients should discuss all side effects with their provider as there may be additional ones as well and some that concern some patients more than others. Just to recap, ozanimod was evaluated in the TRUE NORTH trial and was FDA approved for ulcerative colitis in 2021 and Etrasimod was evaluated in the Elevate UC 52 and 12 trial and FDA approved for UC in 2023.
Now that we have discussed the plethora of medications that are recently arriving on the ulcerative colitis scene, I'm going to transition back to Christina for a discussion on shared decision making. - Thanks Jessica. Yeah, I don't know if I could say those medications three times fast either. So a fantastic job. Clearly the primary care provider really we talk about this with our patients, you know that's your quarterback of care.
So clearly being the primary care provider, they'll frequently have interactions with patients dealing with IBD and sometimes this can be overwhelming or uncomfortable for the healthcare provider if they're not as familiar. Other times it's not clear who has responsibility for what when it comes to health maintenance for these patients such as vaccination and various screening.
We talked a bit earlier on the differences between Crohn's and ulcerative colitis and I think it's also important to recognize the difference between mild UC and moderate to severe. Milder ulcerative colitis is typically characterized by fewer bowel movements, maybe less than four per day, occasional bloody stools and mild abdominal pain.
Moderate to severe ulcerative colitis on the other hand involves more frequent bowel movements, more than four per day or even more than six frequent bloody diarrhea and potentially more severe abdominal pain, fatigue, weight loss or fever. So I think the importance for a primary care provider in following a patient with UC is to understand symptoms can vary significantly from person to person and even within the same person over time.
So it's crucial to have your patient monitor symptoms and report any changes and in the end you have your GI partner to consult with for any questions that arise.
And speaking of partnerships, a multidisciplinary team really is crucial in managing those extraintestinal manifestations I talked about earlier, those EIMs that we see with inflammatory bowel disease because these complications as we reviewed earlier, can really affect various organ systems requiring expertise from multiple specialists. I like to make the statement that skin is the seventh wonder of the world to a GI specialist.
So I'm gonna have that patient see the dermatologist for assistance and figure out what's going on when that patient presents to me with some kind of new carbuncles on their skin, right? Use of a multidisciplinary team approach ensures comprehensive care encompassing the diagnosis, treatment and management of these EIMs which can improve the patient's quality of life.
And then when we think about targeted treatment goals over the past 20 years, when we look back 20 years ago and we think about the rings on a bullseye, a target if you will, way back in the day 20 years ago, we really initially wanted to have our patients feel better and then moving into those rings a little bit closer to that bullseye, we wanted to reduce the use of steroids with the targeted steroid free treatment.
And then as those rings got closer to that bullseye, we wanted to have endoscopic remission. So when we went into scope that patient, we wanted to see that the mucosa looked improved. So what was happening on the outside, we wanted to match what was going on on the inside. We recognize that key efficacy endpoints though in present day involve three categories, clinical remission, endoscopic remission, and deep mucosal or histologic remission.
So again, we want our patients to feel better, we want their mucosa to look normal endoscopically, and then when we take biopsies under the microscope, we want that deep mucosal histologic remission. So we really want that colitis to be quiescent or inactive.
And as discussed earlier on, getting patients identified earlier and started on efficacious treatments sooner to maximize that window of opportunity to treat in early stages of inflammation really reduce long-term complications with the potential to modify the disease in and of itself.
I think another important factor that primary care providers need to be mindful of being often the first touch with the patient for various symptoms would be potential side effects related to biologics or these new novel therapies.
And Jessica already took us through quite a few of these, but kind of in review, when we look at the IL-12 and IL-23, so Ustekinumab or the other IL-23 monoclonal antibody therapies, some of the things that we wanna be mindful of are the potential for upper respiratory infections, nasopharyngitis, headache, there can be some risk of serious infection, non-melanoma skin cancer and as well as other cancers,
although much more rare risk. JAK inhibitors or small molecule therapies can have an increased risk of infection, particularly shingles or other herpes zoster infections like Jessica mentioned earlier, as well as those cardiovascular considerations.
When we think about the S1P receptor modulator, small molecule therapies, these could be associated with a risk of infection such as UTI, again, upper respiratory infections or could be associated with cardiovascular risks including bradycardia or events like blood clots or heart related issues.
The integrin inhibitors such as Vedolizumab have a much better safety profile as Jessica mentioned, than past biologics, but could be associated with upper respiratory infection such as again, nasopharyngitis and headaches and actually some GI symptoms such as abdominal pain, nausea or diarrhea. Occasionally we can see an exacerbation of a patient's UC or Crohn's, last risk with infection and rare risk of progressive multifocal leukoencephalopathy. PML, this is a brain infection.
We don't see this as much with Vedolizumab as with Natalizumab, but again, extremely rare. And again, these are things just keep in mind obviously your GI specialist is gonna be initiating the therapy for the patients with IBD monitoring them as well. But just something to be thinking about in the back of your mind when you're having patients present with some other type of symptom.
And also with any agents that are infused there can be a risk of infusion reactions, but again this is something that would generally be seen fairly soon during the infusion and managed by that infusion team. And we would talk about key considerations for patients on biologics. Let's talk about some best practices around cancer screening and vaccinations for the PCP to be aware of. So patients receiving any immune modifying agents should be counseled against receiving live vaccines.
Inactivated vaccines are safe in patients with IBD and their administration's not associated with an exacerbation of IBD activity. It suggested that patients receive vaccines at the earliest opportunity and preferably to be off steroids or at the lowest tolerable corticosteroid dose if possible.
All adult patients with IBD should be evaluated for latent hepatitis B infection and patients who have previously completed a full hepatitis B vaccine series but are not seroprotected receive a single challenge dose of hepatitis B vaccine. In our adult patients with IBD, we should give them an annual inactivated influenza vaccine. We wanna avoid using live attenuated intranasal vaccines
for this. And in all patients with IBD ages 19 to 64 years of age, they should receive an initial pneumococcal vaccine with subsequent second pneumococcal vaccine administered for those 65 years of age or older. And all patients with IBD who are 60 years of age or older should receive an RSV vaccine. There's no preference for any of the available vaccines in this category.
Then adult patients 19 years of age and older receiving immune modifying therapies or if plans to initiate immune modifying therapy should receive a recombinant herpes zoster vaccine series regardless of their prior varicella vaccine status. So in thinking of some other considerations. Bone density screening should be considered in patients with IBD actually regardless of age and when risk factors for osteopenia
or osteoporosis are present. All adult patients with IBD should be screened for depression and anxiety yearly. And patients who screen positive for depression or anxiety should be referred to the appropriate specialist. But if their primary care provider or mental health specialist can manage it, certainly we wanna be mindful of that and initiate treatment as indicated.
And all patients with IBD should receive age appropriate cancer screening, cervical dysplasia screening, colonoscopy, prostate screening, and in our adult patients with IBD, we wanna make sure these patients are having follow-up skin cancer primary prevention, make sure they're avoiding excessive sun exposure. Patients on immunomodulators, anti-tumor necrosis factor or other biologic agents or the small molecules should undergo yearly total body skin exams.
And patients with any history of thiopurine use should continue with yearly total body skin exams, even if they're no longer on the thiopurine medication. And so one of the things just to think about, anybody should be getting yearly skin checks, right? IBD or not. So thinking about making sure these patients are getting yearly skin checks with their dermatologist and following those skin cancer primary prevention practices.
And I'll reference this a little bit later on, but the AGA came out with a really recent guideline on clinical practice updates for non colorectal cancer screening and vaccinations in patients with inflammatory bowel disease. And this was an expert review that was published in Clinical Gastroenterology and Hepatology here just within the last month. So that's something to reference and I'll come back to that a little bit later on.
Jessica, can you talk a bit more about some of the other key considerations for individualizing treatment decisions in UC? - Absolutely. Thank you Christina. First and foremost, we need to have a good understanding of the location and severity of the patient's disease as this will determine what therapies are available for individual patients. The majority of the medications we discussed earlier today are for patients with moderate or severe UC.
In contrast to them, some patients really do have mild disease, specifically patients who have mild proctitis may only need suppositories or foams or oral medications that do not have as much of an immune effect as some of the medications we discussed. So our starting point should really be where is their disease located and how bad is it? For UC specifically we think about the risk of colectomy being low or high and disease severity as mild, moderate, or severe.
Once this has been determined, you will have a menu of options so to speak, but the decision on which therapy to choose is very complicated and cannot be done in a silo. Multidisciplinary teams in collaboration are essential for almost all IBD patients. Outside of disease severity and location, things to consider include any impending surgeries.
Sometimes medications need to be held around the perioperative time, even if it's not related to the bowels just because of their immune suppressive effects. Any other comorbidities, things that come to mind to me are cancers are very high on the list as well as heart failure. Some of our medications cannot be given in certain classes of heart failure and any other conditions that would make somebody more immune suppressed or more susceptible to an infection.
Pregnancy status is also huge, so they may not be pregnant now if you have a female patient. But knowing their desire and ability to become pregnant or father a child is very important, especially for people that are younger and maybe you know, are newly in a relationship and are at that age where they may be thinking about having children. But even for those who may be a little bit older but are still capable of becoming pregnant,
these are things we wanna think about. As some of these medications are not approved for pregnancy and some are, but may need to be stopped, you know, towards the end of their pregnancy. So a lot to consider there. Patient's ability and willingness to undergo serial infusions or injections. So you know, needle phobia is a huge thing. Access to an infusion center or ability to get home infusions, ability to give yourself a shot or you know, your willingness to let somebody else give you a shot.
These are all things to take into consideration. Generally speaking, medications that are, you know, once a day and pills are much easier to do. However, that's not an option for all of them. If they're only able to take something that's an IV infusion or injection, we have to have really open honest conversations with patients about what they're willing and able to do and, and what is practical or not practical for them.
Even things to consider like what area of the country or world they live in. So where I'm at in Cleveland, we are not so far from the Ohio River Valley, which can put you at an increased risk for fungal infections, which is a problem for patients that are on immune suppression. So there's a lot to think about. And lastly, the big one I would say is insurance with the caveat that that's unfortunate, but sometimes insurance does dictate to some extent what we are able to do.
It's imperative that we include our patients in the decision making process so that we pick the best medication for that specific patient. Specifically in IBD, like I said, many medications are offered via infusion or subQ injection, which have much different logistical requirements than a daily pill. And it may or may not work for all patients.
The nurse practitioner is uniquely positioned to be often one of the very first points of contact and potentially most frequent points of contact for an IBD patient in a GI practice. GI physicians tend to spend a decent portion of their schedule in the endoscopy suite. So the nurse practitioner and support staff are often the one that are fielding a lot of symptom calls, managing urgent visits, making a lot of treatment decisions.
So we have a central role in the care of the IBD patients that doesn't only include your clinical assessment and diagnosis, but also recognition of their disease severity, appropriate treatment options, educating and counseling them and providing advocacy and support for the patient. And that can come in many fashions. I think Christina mentioned earlier, a lot of these patients are requesting, you know, letters for work or potentially FMLA papers.
Although that can be burdensome to your time, it really is something that is supporting and advocating for that patient to get what they need. The NP needs to take a holistic approach to patient care and build a therapeutic relationship with their patient.
In addition, they have a responsibility of working in this area to stay up to date with the treatment guidelines and the rapidly evolving medication landscape in order to be able to provide the best recommendations for their patients, answer questions, address concerns, and give advice. Christina, what resources are out there for APPs regarding IBD if someone needs a reference or wants to learn more? - Yeah, absolutely and and I do think we do like to practice guideline based evidence-based.
So I think practice guidelines from the American College of Gastroenterology and AGA certainly are appropriate, certainly are, you know, still valid to reference even if they're not up to date with these new therapeutic options. But I still think that they serve a good purpose, But I still think that they serve a good purpose, especially in the primary care setting when I don't expect the nurse practitioner in the primary care setting to be necessarily initiating the therapy.
But certainly we'll have a really big role in monitoring these patients and health maintenance. So I think again, the AGA and ACG and, and as I referenced earlier, the AGA certainly has updated guidelines as the AGA certainly has updated guidelines as of last fall. And as I mentioned earlier, this newly published guideline on cancer screening and vaccinations for our patients with IBD through the AGA.
So it was called the AGA Clinical Practice Update on Non Colorectal CancerScreening and Vaccinations in Patients with IBD. And that was an expert review. Again, I think that's a great resource. And then I really find that the Crohn's and Colitis Foundation really is an incredible resource for both healthcare providers and patients as well as their caregivers. And you can access online at www.crohnscolitis foundation.org.
And Jessica, I don't know if you have any other resources that you reference your patients or caregivers to, but I do tend to see the Crohn's and Colitis Foundation to be a really great resource. - Yeah, Crohn's and Colitis Foundation or CCFA is a really good resource. It has sections both for patients and providers. Providers can also get a membership. They have an annual conference, they have a lot of medication guides and things that make it really easy for patients to understand as well.
I also really love, you know, the things that ACG and AGA both have. ACG has a really nice education universe with a section specific to IBD could be really great for anybody. And then of course, GHAPP, which is Gastroenterology and Hepatology Advanced Practice Providers have a slew of education on many things, but they've done a few series on the different IBD meds and things like that that are also very helpful. Okay. Well I think that's all that we have for today.
On behalf of myself, thank you so much for taking the time to listen to this podcast. I hope you learned something new today and maybe have a new appreciation for everything going on in the world of ulcerative colitis. - Yes, thanks everybody for tuning in and thank you to AANP for having us on for this fantastic podcast. And Jessica, always a pleasure working with you as well. So thanks everybody for tuning in. To our listeners, thank you for visiting NP Pulse.
This podcast has been made possible by a medication education grant provided by Janssen. Continuing education credit for this program may be claimed through May 31st, 2026. To claim credit, Login to the CE center at aanp.org/cecenter, search for this program by name, entering the participation code COLITIS25. That is C-O-L-I-T-I-S 25, and complete the post-test and evaluation.
Be sure to download the Ulcerative Colitis Clinical Brief Companion Activity for additional continued education, pharmacology credit and information on this topic.