Freddy Caldera, DO, on the RSV Vaccine for Patients With IBD

Dr Caldera, from the University of Wisconsin School of Medicine, provides an overview of the risks of respiratory syncytial virus to older adults, including patients with IBD, and the importance of ensuring patients receive this vaccine along with those for influenza, COVID-19, and pneumonia.

Freddy Caldera, DO, is an associate professor of medicine at the University of Wisconsin School of Medicine.

Welcome to this podcast from the Advances in Inflammatory Bowel Disease Network. I'm your host, Rebecca Mashaw, and I'm very pleased to have with me today Dr. Freddy Caldera, who is an associate professor of medicine at the University of Wisconsin School of Medicine and a specialist in IBD. He's also become a leading voice for the need for IBD patients to maintain their health through a variety of measures, including vaccines. And today, we're going to be talking about one particular vaccine for one particular disease, and that is respiratory syncytial virus, known as RSV.

So let's start, if you will, Dr. Caldera, with a quick tutorial on this disease. What exactly is it? How does it affect people and what are the symptoms and modes of transmission?

Dr Caldera: And thank you to begin with. Thanks for having me here. And I think, you know, this is such an important topic because as respiratory season is starting again and we're already starting to talk to patients about getting their flu shot, getting a COVID booster, you know, and now we're talking about RSV, you know, there seems to be a lot of vaccine fatigue with patients of like, do I really need to get these, you know, 2 shots and now do I need a third shot? Where did this come from?

RSV is something we've known about for quite a while. It's a common respiratory virus that we knew affected infants and young children. But over the years, we've learned more and more about this disease and know it can impact older adults and immunosuppress populations. So it's a respiratory infection that can spread just like influenza, just like SARS-CoV-2. It can be spread through infected persons when they sneeze. It's a typical pattern. It typically follows the respiratory season. The only time RSV didn't spread through the typical respiratory time was during the pandemic, you know, and as we went out of the pandemic and we lifted mass restrictions, you know, just like we saw an uptake in other respiratory diseases, other infections, the RSV trend went up and down. Right now, the rate of RSV is down, but per data from the CDC, we anticipate that we'll be seeing an increased risk of RSV infections. And we recently published a study showing that patients with IBD are at increased to get hospitalized from RSV.

AIBD: As you mentioned, your recent study did note that patients with IBD are at an increased risk of developing respiratory infections. I know you weren't studying that really in the context of your research, but do we know why? Why are patients with IBD at greater risk?

Dr Caldera: That's a complicated question. For some time, we know that certain patients with IBD are at increased risk for other vaccine-preventable diseases, just like RSV. In our study, it wasn't just being at increased risk for infection, you were more likely to get hospitalized. When we think of the clinical trials and we talk about this term called serious infections, right? So serious infection is an infection that results in hospitalization. So really that's what patients with IBD were. They were at increased risk to be hospitalized due to RSV. And in our study, one of the things that we found it was that those who had been on corticosteroids were at increased risk for an RSV infection. We found that for other infections in the past, we found that corticosteroids increased risk for influenza infections, pneumococcal infections, and in the prevaccine era, corticosteroids resulted in severe COVID outcomes.

So it's probably multifactorial, not all of the medicines that we use to modify the immune system work in the same way. Certain patients with pre-existing conditions like chronic lung disease, you know, diabetes, we know can be at an increased risk for RSV, but the big culprit we found was corticosteroids.

AIBD: Did you notice any other signals of increased risks with either other therapies or due to patient age? You mentioned comorbidities? Did you find other indicators that need to be considered by clinicians when they're working with patients who have IBD, who may be at risk?

Dr Caldera: So in our study, we not only looked at the patients who are currently eligible to get an RSV vaccine, we looked at all adults. And in our study, we found that all adults were at an increased risk to get an RSV infection that resulted in hospitalization, not just those 60 and up. We found that those with cardiovascular disease were also at increased risk for hospitalization, those 60 and up. So age was a risk factor.

But in our study, all adults were also at increased risk. And cardiovascular disease, a known risk factor for RSV, also was associated with increased risk for being hospitalized.

AIBD: Is the vaccine going to be available for people who are under 60 but who are at higher risk based on some of these other factors? I think at this point, it's still 60 and up, is it not?

Dr Caldera: It is. And this is where, you know, there's a lot of work we need to do. I guess the RSV vaccine has been a long process. Right now, I think one of the biggest things that we know is that probably RSV is underdiagnosed. It's not something that was commonly tested for if someone showed up to the hospital or the urgent care, because there really was no treatment. So we know that there's probably people who had RSV and they didn't know it, because when there's no treatment for it, why use a special complicated respiratory panel to diagnose this?

The studies to look at the vaccine preventing severe disease or preventing hospitalization has always been in adults 60 and up. So in order for this vaccine to be available for younger patients, there's a couple of things need to happen before the ACIP or the people who advise the CDC recommend lowering that age. If you think about it, this is similar to the shingles vaccine. When the shingles vaccine first came out, it was recommended only for 50 and up. Then studies needed to be done to look at the safety and how well this vaccine worked in immunosuppress populations in 19 and up before the CDC was going to lower the age. The FDA label also states that this vaccine can be given only 60 and up other than one from Pfizer; that can be 50 and up.

So there's a lot of things that really need to happen, and that's where our team is hoping to do this work, but I would tell you what's the take-home point. If you're a provider taking care of patients with IBD, the RSV vaccine recommendation is a little hard to interpret if you just go to the CDC website. It states if you're 75 and up, you should get the vaccine. It states if you're 60 to 74 you should consider getting the vaccine if you're at increased risk.

The goal of our study was to evaluate this and that's why we're very excited that the results came out now because our studies show that patients with IBD are at an increased risk. So those who are 60 to 74 should definitely be getting an RSV vaccine. There's currently 3 RSV vaccines that are available. There's one by Moderna, Pfizer, and GSK. None has preferred recommendation from the CDC. The only vaccine that's used in special situations is the Pfizer vaccine. It's recommended for pregnant women during their third trimester, who will be 32 to 36 weeks pregnant from September to the end of January. And that’s to protect their infant from an RSV infection.

AIBD: You mentioned that one of the reasons people weren’t tested for RSV was because there really was no treatment available for it. Is there any treatment for it available now? What do you do if you do get RSV? How do you manage those patients?

Dr Caldera: For kids, there is an antibody that you can use. It's a monoclonal antibody that's very efficacious. That hasn't been transferred to adults yet. So really it's a supportive disease, but right now, and I think in the future, we'll be able to provide this vaccine for all our adults. And right now, we don't, you know, there's a lot of work that needs to be done. Will people need boosters? We don't know that yet. You know, right now, it's a vaccine that's a one and done, but potentially because it's a respiratory infection, we need to see if providing boosters results in, you know, preventing further hospitalizations.

So a lot to know. But again, I would tell you, I would tell a provider, the simple thing to do would be to advise patients, just like they're getting flu, just like they're getting COVID, RSV is something that we're, you know, we have data that can put you at risk to get hospitalized. And it's something that we can potentially prevent. So they don't need to get all 3 of the vaccines at the same time if they don't want, but it's something they should be planning to get prior to this respiratory season coming up.

AIBD: Has there been any problem obtaining the vaccine?

Dr Caldera: No. I mean I recommend my patients get a vaccine using a local pharmacy— that can be very easy way. We're hoping to get this vaccine in their clinic soon, but we don't have it yet available. But getting the vaccine for those who are eligible, because if you want this covered by insurance, you have to follow the CDC recommendations. So that's only 60 and up.

AIBD: What would you say to patients who are not 60, who have IBD, who may be at greater risk of contracting this disease and ending up in the hospital with it. What can they do short of having a vaccine to protect themselves?

Dr Caldera: I mean, I think making sure they're up to date with everything else. While RSV is one respiratory disease, I mean, we have lots of data regarding the impact of COVID, regarding the impact of influenza, make sure they're up to date with, you know, with their pneumococcal infection, you know, if there's a high peak of COVID or influenza and they feel more comfortable wearing masks during high respiratory seasons, that's not unreasonable.

But I think what we learned from COVID is that a lot of the therapies we use don't suppress the immune system as much as the medicines used for solid organ transplant recipients. The big other thing I would tell patients, if you're on corticosteroids and you don't have an exit plan, talk to your provider. While corticosteroids, some patients don't experience severe side effects, a lot of patients can. Corticosteroids are the biggest culprit. So if they don't have an exit plan of how they're going to get off work with steroids, that's a big thing that they need to make sure that their provider is working on a plan of how are we going to get you off those steroids.

AIBD: So do you have any further research plan perhaps in that younger population of patients to help make the case for why this vaccine should be available to everybody, all adult patients?

Dr Caldera: Yes. I have a plethora of plans. It's more finding the time and funding to do all this important work. And, you know, we have a great team at Wisconsin, and we're hoping to be able to share the impact of ours, be in patients with IBD, to kind of make that argument that the age should be lowered soon. So, so hopefully we'll have some data to share soon.

AIBD: Very good. Well, thank you so much for your time today. It's very interesting and we'll look forward to talking with you later when you have more research results to share.

Dr Caldera: Well, thanks for having me again.