Managing Patients With CLL in the COVID Era: The Advanced Practitioner's Role

Chapter 2: COVID-19 Vaccination Efficacy Among Patients With CLL

What are the facts about the safety and efficacy of COVID-19 vaccination in the CLL patient population? Join our expert APs as they talk through this complex topic.

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Chair

Lisa Nodzon, PhD, ARNP, AOCNP

Moffitt Cancer Center

Faculty

Jackie Broadway-Duren, PhD, DNP, APRN, FNP-BC

MD Anderson Cancer Center

Katherine Tobon, PharmD, BCOP

Moffitt Cancer Center

Transcript

Lisa Nodzon: Welcome to this virtual roundtable, Managing Patients With CLL in the COVID Era: The Advanced Practitioner's Role. My name is Lisa Nodzon. I am a nurse practitioner in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, Florida. Today I am joined by two of my colleagues, Jackie and Katie.

Jackie Broadway-Duren: Hello everyone. I'm Jackie Duren and I am a nurse practitioner at MD Anderson Cancer Center in the Department of Leukemia.

Katie Tobin: Hi everyone. My name is Katie and I'm a clinical pharmacist in malignant hematology at Moffitt Cancer Center in Tampa, Florida.

Lisa Nodzon: In our second installment, we will focus on the efficacy of COVID-19 vaccinations in the CLL patient population. Recent publications in Leukemia by Dr. Mato and also in Blood by Dr. Ghia and colleagues both have confirmed what we have known regarding the lack of vaccine efficacy in our CLL patient population due to the impaired humoral immune response. Dr. Mato's group showed 52% and Dr. Gia showed 39% response rate in CLL patients following two doses of either the Pfizer or the Moderna COVID-19 vaccines. Both groups that showed the highest rate of responders were those CLL patients that had obtained a clinical remission after their treatment, followed next by the treatment-naive patients. Whereas the serological response was significantly less in those patients with CLL that were receiving a BTK inhibitor or venetoclax. And as we know, none of the patients that had been exposed to an anti-CD20 monoclonal antibody within the preceding 12 months had any response to the vaccine.

Jackie, given this data that we recently saw published in those two publications in Leukemia and Blood. How do you explain this to our CLL patients considering that right now in the setting of this pandemic, their anxiety levels are rather high?

Jackie Broadway-Duren: Oh yes. Thank you for that question. Well, as you probably know, most CLL patients are very savvy about all the information about CLL vaccines and everything. Many of them are on blogs where they get sometimes erroneous information, but many of them were already aware about the decreased efficacy of COVID [vaccines]. So all we can do is tell them that we still advise them to get it, despite the fact that they may or may not form very many antibodies.

Also, we discussed the current data to give them the facts of what was going on as far as efficacy studies. In addition, we try to emphasize that we know that the data has shown that those that have taken BTK inhibitors are least likely to develop those antibodies that's noted by Roker et al in the article in 2021, as well as what we've seen at MD Anderson. Also, the treatment-naive patients, we have shared those that they are more likely to form the antibodies than those who were previously treated.

Lisa Nodzon: Do you have any other practice-based implications that you changed with your CLL patients in terms of looking at or encouraging extra vigilance within them?

Jackie Broadway-Duren: Each day, each and every day, every phone call, every email, we're always encouraging the patients to continue to be vigilant and wearing their mask and social distancing. According to CDC guidelines, despite whether they've had the vaccine, we still encourage them to be vigilant with those things. Also, we encourage them to encourage their families as well to get vaccinated. And if, I've had cases where patients’ family members refuse to be vaccinated, they develop COVID, and so then you put the patient at risk, and unfortunately, some patients due to that exposure did develop COVID. So in consideration of all those things, we just try to encourage them to do what they can to keep themselves safe and separate themselves from family members who obviously may not choose to take the vaccine.

Lisa Nodzon: Yeah. A lot of infectious precautions go with our CLL patients even before the COVID pandemic. And I think now, as you mentioned in the setting of the COVID pandemic, it's even extending further out with discussing with the household and the household members to get the vaccine as well – what surrounds our patients, right?

Katie, do you see any clinicians changing their treatment modalities and effort to deliver the vaccine to CLL patients, whether they're holding therapy to deliver the vaccine or any other changes because of the pandemic?

Katie Tobin: This is a great question. So when the vaccine first came out, our main priority was offering it to all patients who are at high risk for poor outcomes, which is pretty much all of our patients, especially the CLL patients. Now at first, I don't think we really modified treatments because we were really unsure of how many vaccines would be available, but it still is very provider and disease specific. So there are other disease states among heme that we could delay treatment a little more, but I would see the providers try to either hold the CD20-targeted therapy. As you had mentioned, we know that patients have poor response, if not any response, with CD20 therapy. However, we do offer the vaccine to most hematologic patients outside of BMT and CAR T. And because we know, even though they're not going to get a response, we know it's not unsafe.

Katie Tobin: But I can't say this enough, especially with, Jackie said it, Lisa, you said it, really it's important to counsel patients that they still have to continue those other COVID-19 precautions. So wearing the mask, social distancing, and then really speaking to the family members because that's really where one of the biggest risk factors comes in.

Lisa Nodzon: Yeah, absolutely. I feel almost like your education base has increased beyond that of the patient as well too. Because, as you mentioned, it's kind of been difficult for us in the beginning. We were a little blinded with things in particular, even with giving steroid doses to our patients, should we omit steroids from their regimen? Should we continue steroids? And we had no data other than kind of relying on older data. So we've kind of evolved at least through that definitely with our pharmacist help and some of the real-world data. And then moving into looking at our CLL patients in terms of outcomes with COVID-19. As we know infections, we are no stranger to that knowledge in our CLL patient population with hypogammaglobulinemia. But if we look at some of the real-world data, the effect of COVID-19 on CLL patient outcomes was recently published in Blood by Dr. Mato and colleagues across 43 international centers with a population of around 198 patients, which is representing one of the largest studies to date. And what they found was that there were similar rates of hospitalization as well as ICU admissions, intubation, as well as mortality amongst patients that were undergoing watchful observation as compared to those patients that were being treated, roughly around 30% for each of those cohorts. Of course, the patient population in those groups that had the highest comorbidity burden based on CIRS scores greater than 8 with the greatest risk as would stand to reason. Some predictors that came out of that study for poor overall survival were smoking history, age 75 years and up, as well as having asthma, diabetes, and chronic renal disease as well. So with knowledge in hand, on top of what we've already known about our CLL patients being at increased risk for infections, Jackie, are there any new practice-based implications that you would have for your CLL patients in terms of providing them with extra education as well as safety?

Jackie Broadway-Duren: Well, yes. What we try to do is reinforce timely screenings, vaccinations, and follow-up visits with providers. I'm sure in your practice, you also have patients who are repeat offenders who don't always keep their appointments in a timely manner. So we do try to encourage patients to follow up. And we have so many patients who travel from outside areas. We try to encourage them to have an active relationship with their primary care providers, take your medications on time, self-care, self-monitoring. And one of the most important things that I've learned through this as far as patient care is patients who already have some emotional instability, that has really worsened through this process. So we do try to encourage them to get counseling when needed, or whatever they need to take care of the whole self. And we've had to get social work involved, dieticians, or whatever is needed to try to keep that patient whole.

Lisa Nodzon: Yeah, we saw the same thing I have to say too. I think particularly when the lockdowns in the beginning were enacted, we saw increased rates of depression and loneliness in our patients, particularly those that lived alone, and just that heightened sense of fear and anxiety that they went through. So right – it really brought on a new onset of psychosocial management in our patient populations as well too. And then when the vaccine was rolled out, overcoming some of that vaccine hesitancy as well, represented a challenge, I'm sure you probably saw the same thing in your patients as well too. So many challenges had come out of that for sure. And some of our patients are still undergoing, as you mentioned as well, the psychosocial management and support, which they had the previous issues from an emotional standpoint, but at least now they're getting some help for that. So that's been a benefit for our patients.

And Katie, how about the use of the COVID-19 therapy and hematology? As we know, it's evolved over time as initially data was incredibly lacking, particularly with our hematology patients. And course we have Regeneron's monoclonal antibody product. Do all hematology patients meet this eligibility for the treatments?

Katie Tobin: That's a great question. So we have come a really long way with the different monoclonal antibody treatments available. So the latest, and as you said, the Regeneron or the REGEN-COV is the most widely used and preferred product. So this particular product is a combination of two neutralizing, monoclonal antibodies, casirivimab and imdevimab.

So what this is, is it's IgG1 monoclonal antibodies with unmodified FC lesions, and they made it this way that it's unlikely that a mutation specifically in the protein will simultaneously render both antibodies ineffective. So that's why the combination product really is the most preferred. So what it is, is this has now been authorized by the FDA for two different indications. For one, for the treatment of mild to moderate coronavirus-19 or COVID-19 in adult and pediatric patients, 12 or older with a positive test who are high risk for progression to severe COVID-19, including hospitalization with death. So your question, do our patients meet criteria? I would say yes, especially all of our CLL patients as the data you presented. We know that they are at higher risk for progression to severe COVID-19. It is important – I do want to point out that it's not authorized for use in patients who are hospitalized, who require oxygen due to COVID, or if they're having an increase in oxygen from baseline.

And then the other indication is that more recent is the post-exposure prophylaxis. And again, most of our patients would meet criteria. So, the indications would be it's authorized for use in post-exposure prophylaxis of an adult or pediatric patient who are at high risk for progression of severe COVID, including patients who are not fully vaccinated or not expected to mount an adequate immune response. And as we have talked about, we know our CLL patients, especially ones on treatment with our BTK inhibitors or monoclonal, the CD20s we know that they will not mount that immune response. So yes, we've come a really long way and we are using this product very widely in our patients. And I would say most of the time it's always patient specific, but yes, most of our patients do qualify for the monoclonal.

And the other thing I did want to point out is the monoclonal is not a substitution for vaccination, and then going back to vaccination, if the patients have received the monoclonal, then they actually should not be getting vaccinated for 90 days. So that's another thing that we have to think about and weigh the risk/benefits with each of our patients.

Lisa Nodzon: Yeah, that's a great teaching point with some of our patients that have had some vaccine hesitancy too. They're like, well, I can just be treated for COVID if I come down with COVID. And so a lot of education has to go into the eligibility for the product itself and the fact that they could still have a higher mortality despite this product. So again still having to encourage our patients to get the vaccination is extremely important, but letting our patients know that perhaps if they're on therapy, they're doing the right thing, they're doing the social distancing, they're wearing their mask and they're avoiding the crowds, that there is at least a product on the market for them given the higher mortality risk that we just saw with that data. So a lot more education, again, still having to come out at these visits with our patients.

But again, we're still encouraging vaccinations. Although we do see the data on the impaired humoral immunity following the initial two vaccination doses, of course, with this third vaccination that's coming out, I'm sure there'll be more data to come on the serological response in our particular patients. So we're going to stay tuned for that as well. The COVID-19 pandemic, as we've seen, has higher risk for mortality in our CLL patients, just due to this underlying immune dysfunction, their advanced age, as well as comorbid conditions. I know we've been giving a lot more immunoglobulin product as well to our patients, making sure that their IgG levels are staying adequate for them as well, particularly post-COVID infections, and our patients where we're seeing lots of post-COVID pneumonias, as Jackie mentioned earlier as well, we are encouraging the households as well as those caregivers that surround our patients to be vaccinated.

And particularly with the holidays coming up as well. I know I take it a step farther with some of our patients and I even recommend whoever's coming into the home for the holiday dinner at least have them swabbed for COVID so that you know that everyone coming into the household is COVID negative as well despite the vaccination status. It's important too that as advanced practitioners as well as other healthcare providers should be vaccinated. And particularly because we are taking care of a very highly vulnerable patient population, and we are making sure that we are following, ourselves, CDC guidelines for our patients, but also it's been a nice time to also reinforce vaccination status for other things as influenza season is right here as well for our patient population. So we're even talking about the flu vaccine as well as making sure our patients are up to date on the pneumococcal vaccines and bringing up the Shingrix vaccination as well.

So that brings us to the end of this discussion. Please see the other segments for further discussion about the management of patients with CLL in the COVID era or visit advancedpractitioner.com. Thank you for joining us today.