IBD Drive Time: Does My Patient Need a COVID-19 Vaccine Booster?

Questions are flying about whether the FDA-CDC recommendation for patients with immune suppression to receive a third COVID-19 vaccine applies to patients with inflammatory bowel disease. In this IBD Drive Time podcast, Millie Long, MD, talks with Freddy Caldera, DO, about how to advise patients with IBD on vaccination, risk of severe disease, and whether to have antibody titers checked.

Millie Long, MD, is an associate professor of medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina. Freddy Caldera, DO, is an associate professor of medicine at the University of Wisconsin.

TRANSCRIPT:

 Dr Millie Long:  Hello, and welcome to IBD Drive Time. I'm Millie Long, along with Ray Cross, hosts of this podcast. Today, we are thrilled to welcome Freddy Caldera, who is associate professor of medicine at University of Wisconsin and a true expert in vaccines. That is one of the hot topics right now. Obviously, we want to focus a little bit on the COVID vaccine, and particularly in inflammatory bowel disease patients.

I'd like to thank our sponsors. This podcast is sponsored by Advances in IBD as well as the Gastroenterology Learning Network. I'd also like to remind everyone listening that there are 2 upcoming fantastic regional conferences that Advances in IBD is putting on. One is September 11th and the other is the 25th. Please do register and join us for one of those conferences.

With that, I'd like to start on our hot topic of the day and welcome you, Freddy. Thanks so much for joining us.

Dr Freddy Caldera:  Thank you for having me. I would love to talk about vaccines any time, and especially now when there's so many questions and things change all the time, right?

Dr Long:  Absolutely. Right before we started, one of the things we were talking about is the patient message volume about vaccines has gone through the roof. We really need to be able to provide them with appropriate information surrounding, not only their risk of developing COVID, but vaccines, how protective they are, how safe they are.

Obviously, one of the things we'll touch on today is some of the more recent guidance about whether patients with inflammatory bowel disease need a third vaccine or a booster vaccine. I want to start with some background questions, Freddy, so that we can all be on the same page.

What have we learned about COVID infection in patients with inflammatory bowel disease? Are patients with IBD at increased risk? Are these more severe infections?

FD:  Thankfully, we do have some of that information that, from a patient perspective, whenever they're seeing the news or they see articles in the New York Times talking about immunosuppressed patients, we know that just having IBD, just having Crohn's or ulcerative colitis, doesn't increase your risk for a bad COVID outcome.

You're not more likely. We have great data from SECURE to tell us that. We also know that the therapies we use to treat IBD don't increase the risk; other than the traditional risk factors like certain comorbidities and steroids, those are the only things that are associated with a worse COVID outcome.

Dr Long:  Great. So in general, although, of course, there's risk for everyone, the risk is not necessarily increased, except with those certain medications. Clearly, in my practice, I'm trying to avoid high-dose steroids if I can here for that reason. That seems to be one of the big risk factors.

What about vaccine efficacy? We've had vaccines for a little while. Many of our IBD patients were in some of the first waves of vaccinations. At least for me, many of my patients got vaccinated back in March. We've had a little bit of time to understand about these vaccines. What do we know about efficacy?

I know you're doing a study in Wisconsin. What have you all learned, and what do we know more broadly?

FD:  In our study. that we should put in preprint soon, what we found this that just like in your study with PREVENT IBD, with CORALE-IBD, is that the majority of patients are able to mount a vaccine response, which is the first question. When you think of immunosuppressed patients, and this, we'll get later on and talk about the ACIP's decision, because other populations, they weren't able to mount a vaccine response. We're seeing our patients mount to that vaccine response, because not all vaccines are created equal.

Some vaccines work really well, and that's what matters. When I try to reassure my patients, I tell them, "You're not at increased risk. You don't have certain comorbidities. Your medicine doesn't put you at risk."

The majority of patients respond to vaccines. Help them reassure, because I've seen a lot of mental health issues from the scare that when we think of back of March 2020 of talking about immunosuppressed people being at such high risk, and then as things get better, they keep hearing these mixed messages in the media of, "Hey, are you at high risk?"

I think we can provide great reassurance to our patients that that's not the case.

Dr Long:  I completely agree. Like you, we have done a study here called PREVENT COVID, and we've found over 95% of our patients with inflammatory bowel disease are mounting a vaccine titer initially.

I think one of the key questions is whether that vaccine titer will persist over time. As part of our study, and I know as part of yours, we are continuing to follow up and check repeat titers. That's the first thing I lead with when people ask me these questions.

But what's interesting is that recently, just within the past week, there's been guidance, both from the FDA and the CDC, that patients who are severely immunosuppressed should get a third vaccine. Can you break that down for us? Can you tell us a little bit more about the CDC and the Advisory Committee on Immunization Practices that obviously helps to make that decision?

What are the data they're using, and which of our IBD patients are potentially at risk and meet that qualification and should, frankly, in those instances, be going out and getting that third vaccine?

Dr Caldera:  I think an important thing when we talk to our patients, whether they're getting an extra dose, is talking to them of why. Unlike other patients, we know patients with IBD are not at increased risk for severe COVID, which you're either hospitalized or you die.

That's not the same for solid organ transplant patients. That's not the same for cancer patients or other immunosuppressed. So because of that, and because other trials, specifically in solid organ transplant patients, the Advisory Committee on Immunization Practices has been meeting and talking about this since July and saying, "What are we going to do about it, because this is speeding along?"

As things took a turn in the country, and now Delta's rampant, they decided, "We can't wait on this. We can't wait for the science,” which is what we typically do. We need the large studies, the randomized trial where you give a booster and you don't.

That's not going to happen. We did have some signs saying a certain amount of solid organ transplants didn't mount a vaccine response, unlike the studies in IBD.

The FDA made an amendment to the EUA and said, "If you have the equivalent immunosuppression of a solid organ transplant patient, you should get a third dose, because that third dose is intended so that you become seropositive, or you mounted a vaccine response."

Because of that, the Advisory Committee on Immunization Practices said, "If you're 'moderately to severely immunosuppressed'." It's a hard decision for them, because, A, it's hard to keep up with the IBD data on COVID to begin with. How can you keep up with the data of all COVID and immunosuppression? So they gave a general recommendation to err on the side of caution and say, "If you're on immune-modifying therapy, if you're immunosuppressed, you should get a third dose."

This is where that message is important, at least for my patients. I want you to know if you choose to get that third dose, it's not because we didn't think the vaccine didn't work right away. It's probably because if you got vaccinated in March, maybe your antibodies are lower. And since we're all going to get boosters anyway, it doesn't matter anymore.

Dr Long:  I know the ACIP gave some loose definitions of who they feel meets that criteria for moderate to severe immunosuppression. What are those? Are there specific medication classes that you would consider more at risk?

Dr Caldera:  Yeah, and this is where they were specific and talked about anti-TNFs, antimetabolites. You have to know where that definition came from. That definition came from a book called CDC Yellow Book, which is recommendations for providing a live vaccine.

It's not because people on those therapies were at higher risk for COVID, or because they were at risk of not seroconverting. But they had to choose something. That's the trouble. That's where the Crohn's & Colitis Foundation's position statement provides some good reassurance for what the providers should do, because it's hard to keep up with what should you be doing?

Dr Long:  Absolutely. I'm glad you mentioned that, because one of my questions for you is going to be resources for patients. I know you were involved in the recently released Crohn's & Colitis Foundation position statement. Where could providers find that so that they can drive their patients there to answer some questions?

Dr Caldera:  It's on the Crohn's & Colitis Foundation page. I think the Foundation has been doing a great job and keeping patients and providers up to date. And I know you and many others have worked endlessly to help keep that updated so we can provide good information for patients and providers.

It spells out why the third dose was recommended. It provides reassurance that our patients are not increased risk for COVID and that they responded to the vaccine. They talk about how that third dose, people on anti-TNFs, antimetabolites, and then you have to start talking if you're not on those therapies. If you're on ustekinumab or vedolizumab, what do you do?

It gets a complicated decision, where if I have a 65-year-old diabetic on vedolizumab, and they can get a third dose now, and everyone's going to get boosters pretty soon, I'm going to tell my patient, "Go get a booster, because you’ve got a couple of risk factors, in a way, for high risks of COVID."

Dr Long:  Absolutely. I'm practicing the same. The take-home messages from this — hopefully, in this quick 15 minutes of Drive Time, folks have gotten those —are, 1, patients with inflammatory bowel disease do not have increased risk of severe complications from COVID. This is not different than the general population.

That said, of course, everyone has some baseline risk associated with COVID. The second is that vaccines are effective in patients with inflammatory bowel disease, particularly the 2-dose mRNA vaccines. We're seeing very appropriate titers in our study, over 95% after initial vaccination.

Importantly, we're also not seeing flares of IBD. My patients ask about that a lot. We have not seen flares of IBD associated with vaccine implementation, and that's true. There have been many studies of other vaccinations that have shown the same thing, that these do not flare inflammatory bowel disease.

Lastly, that a third dose is available for people who are moderate to severely immunosuppressed, but that the definition of that is somewhat loose. Have a conversation with your doctor about whether you should get this vaccine. Most likely, everyone will be getting a third dose at some point in the future.

Anything you'd like to add to that summary, Freddy? I've learned a lot. I've so enjoyed having you on this Drive Time.

Dr Caldera: I guess the last thing, I know a common question that people get is, can I get my antibody test, and what does that mean? Right now, the FDA and the CDC don't recommend getting antibody tests done, because no one knows what that means.

We don't even know if antibodies are going to be the correlate of immunity. And while it might seem harmless, you can create a lot of anguish in a patient if their test comes back negative. Because maybe the test is not good enough at measuring antibodies.

Dr Long:  That's a great point. It's a great point to end on, too. One of the things I even tell my patients is there are multiple types of tests. A test against the nucleocapsid, which is marketed as an antibody, shows prior COVID infection, but it's not going to show vaccine response to the spike protein.

Even knowing what type of antibody tests you're getting, it may not even demonstrate anything if you're trying to check postvaccination titers. That's typically my response to my patients. I have not been ordering these tests outside of a study.

That said, there are a number of ongoing studies where people are following patients and checking various antibody titers over time. Freddy has a study out of Wisconsin. Remind me the name of your study, Freddy.

Freddy:  I didn't come up with a fancy study. We just called it an Immunogenicity Study.

Dr Long:  Immunogenicity Study.

Dr Long:  We have PREVENT COVID, which is an online study of pediatric and adult patients with IBD postvaccination, where we're following symptoms as well as antibody titers.

I want to put a shout-out to Gil Melmed, who's at Cedars-Sinai. They have the CORALE-IBD study. CORALE and PREVENT, you can do remote recruitment, too. That's something to look into if you are interested in participation in a study. Please direct your patients there as well.

With that, I'm going to wrap up. We enjoyed this IBD Drive Time. Next up, Dr. Cross and I will be interviewing Miguel Regueiro, who will talk to us about postoperative Crohn's disease management. See you for your next drive.

REFERENCE:

Caldera F, Balzora S, Hayney MS, Farraye FA, Cross RK. Ensuring high and equitable COVID-19 vaccine uptake among patients with IBD. Inflamm Bowel Dis. izab114. https://doi.org/10.1093/ibd/izab114