Episode 16: Using Monoclonal Antibody Therapies to Fight COVID-19 with Chance Mysayphonh, Pharm.D.
While the distribution of COVID-19 vaccines continues across the country, the FDA has also recently granted Emergency Use Authorizations (EUA) for new monoclonal antibody therapies specifically for COVID-19 patients living with chronic kidney disease. Chance Mysayphonh, PharmD, clinical pharmacist for Fresenius Medical Care North America, joins Field Notes to discuss how these exciting new therapies will be used in Fresenius Kidney Care centers.
Brad Puffer: Welcome, everyone, to this episode of Field Notes. I'm Brad Puffer, on the medical office communications team at Fresenius Medical Care North America, and your host for this discussion today. Here we interview the experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day. While two COVID-19 vaccines are now being distributed across the country, there are new therapies that have also received emergency use authorization by the FDA.
These include monoclonal antibody therapies that have been called out specifically for use with patients living with chronic kidney disease. They are designed for COVID-19 patients with mild to moderate symptoms and who are at risk of progressing to severe symptoms or hospitalization. One of these new therapies is now being administered in Fresenius Kidney Care centers, which are uniquely equipped to identify COVID cases in our patients early, and provide this therapy when it makes the biggest difference.
So what is a monoclonal antibody therapy, and why is it so effective? How are these therapies developed, and how are we working to make sure they can get to people who need them? Here to answer these questions and more is Chance Mysayphonh, clinical pharmacist for Fresenius Medical Care North America. Dr. Mysayphonh is the lead pharmacist in charge of a project to train and educate our front line care teams on this new therapy. Dr. Mysayphonh, welcome to Field Notes.
Dr. Chance Mysayphonh: Hi, Brad. Thank you for having me here.
Brad Puffer: Well, as one of our company's lead pharmacists, who has been following the developments of these therapies very closely, tell us what are monoclonal antibodies, and just how do they work?
Dr. Chance Mysayphonh: So monoclonal antibodies in general are a protein. So these are laboratory-made proteins that are designed to mimic our immune system's response to foreign substances. So there are several different types. The one that you're probably more familiar with is the one for treatment of rheumatoid arthritis, things like that. These are the immunomodulatory monoclonal antibodies. These antibodies respond to foreign substances-- to different antigens-- by sticking to them, so once attached, they can recruit other immune cells to destroy the foreign bodies or the foreign antigens.
Brad Puffer: And as you alluded to, this has been around for quite a while. This technology is not necessarily new, but it's pretty exciting.
Dr. Chance Mysayphonh: It's been studied for over 30-40 years. But we didn't get the first commercially available antibodies until the mid-1980s-- and some of us may be familiar with this-- the product called Orthoclone. So these were used originally as an immunosuppressant drug to prevent acute organ rejections in organ transplant patients. A lot of these monoclonal antibodies that are out now that have been on the market were mostly designed to treat either autoimmune disease or cancer therapies, because they are so targeted at our own immune cells. But the one that's available now for COVID-19 are antibodies targeting a foreign substance like the virus itself. So that's what makes it different.
Brad Puffer: So why don't we dive into that a little bit more, Chance? You're saying that is the first type of monoclonal antibody therapy that's worked this way?
Dr. Chance Mysayphonh: It's not something new, but it's not usually explored, because it's mainly used to treat an acute infection. If you look at the history of monoclonal antibodies, there's been some that are used for RSV virus, for example. It targets the virus itself. But that's not really readily available. It's only used in certain cases, where there's likelihood that the mother can transfer the virus to the fetus, things like that. There are cases-- so Ebola virus, for example, that use monoclonal antibodies to prevent progression of Ebola or prevent the progression to severe Ebola virus infection.
Brad Puffer: And in this case, we have a situation where we really can make a difference if we get this therapy to patients early. Some people may wonder how was this antibody therapy so quickly developed? You talked about the history, and how long it took until we got antibody therapies into market. Now we've done this in a year. How did that happen?
Dr. Chance Mysayphonh: Once you discover how to do it with the different methods of doing it, you tend to be more efficient at doing it. We have been designing these antibodies for a while. What happened was during the pandemic, we actually isolated these antibodies from convalescent patients that recovered from acute viral infection, and actually isolated the most effective antibodies in there and cloned them. So that was why we were able to develop so quickly. So these antibodies are not something we engineered. It's more something we cloned from people that recovered from the acute viral infection and now using it as a way to neutralize the virus.
Brad Puffer: Well, I want to turn from the history and the details of these antibody therapies to how it impacts patients with chronic disease, especially patients with chronic kidney disease. Why are these therapies so important for people with CKD?
Dr. Chance Mysayphonh: So most CKD patients are at an increased risk of progression to severe COVID when they become infected with SARS-COV-2. So in the ESKD population, for example, these patients are at an even higher risk due to the co-morbid conditions, such as cardiovascular disease, hypertension, and diabetes. So the abnormalities in that innate immune system for ESKD patients may prevent these patients from mounting an immune response quickly. The studies that came out showed that monoclonal antibodies such as bamlanivimab when given early for these high risk COVID-19 positive patients, can decrease the viral load, and reduce hospitalization.
Brad Puffer: Well, I briefly explained some of the parameters for distribution of this therapy and who it's meant for, but I'm hoping we can take a deeper dive into that. Who really should receive these antibody therapies, and who should not, and is there a screening process?
Dr. Chance Mysayphonh: At Fresenius Kidney Care, we have a system designed to screen patients to see if they're appropriate or not for the treatment with these monoclonal antibodies. So these COVID-19 monoclonal antibodies are therapies that are approved by the EUA for COVID-19 positive patients that are at high risk for progression to severe COVID-19 disease. So as you mentioned earlier, these are patients with CKD, diabetes, immunosuppressive disease, and other risk factors.
And the other important thing to note here is these therapies must be given within 10 days of diagnosis. Ideally, these therapies should be given as soon as possible. So in our internal process with Fresenius Kidney Care, we have a process in place to assist prescribers and our staff to meet these criteria set out by the EUA.
Brad Puffer: A lot of people may have been reading about these antibodies. I certainly have read a lot of news about some of the concerns over administrating the therapies, and really getting them out there to the population, especially challenges in hospitals, who are already overburdened with COVID cases right now. Are these challenges real, and how are we overcoming those?
Dr. Chance Mysayphonh: So yeah, these challenges are real. But it's a little different for the hospital system. So to us, initially, we were not able to get the product in our clinics. So when these monoclonal antibodies came out and got approved with the EUA and by the FDA in November, the distribution was actually left to the state to decide who gets the product. And most of these products were distributed to the hospitals.
But unfortunately, the EUA specified that these therapies are not indicated for hospitalized COVID-19 patients and can only be used for the treatment of mild to moderate COVID-19. So that's actually barred a lot of patients that were hospitalized from getting this therapy. And the other issue is what you mentioned. Hospitals are already overburdened with COVID-19 patients, and these are severe cases. And they do not have space to actually give the infusion that can last as long as an hour and require an additional hour of observation.
Brad Puffer: And so it seems Fresenius Kidney Care really has an opportunity to help our patients here. What makes our network of clinics such a great screening and delivery mechanism?
Dr. Chance Mysayphonh: We were able to reach out to HHS and work directly with them to get these monoclonal antibodies to our clinics. So this made it easier to centralize the process and make the nationwide distribution to our clinics a lot easier. So Fresenius Kidney Cares are able to work with distribution partners to be able to deliver the medication to our isolation clinics within 24 hours. And all of our clinics have policies and procedures in place to screen for COVID positive patients.
And these patients that are COVID-19 positive are sent to be dialyzed in our isolation clinics. So this is when we have the opportunity to administer the monoclonal antibody infusions. And also, our frontline care teams are highly trained in giving IV therapies, and almost all of our patients have IV access, making us the ideal place to give the medication.
Brad Puffer: And maybe you can talk a little bit about just how that medication is delivered. So somebody who is diagnosed early with COVID gets a prescription from their doctor for this new therapy, and then we're able to administer it, how exactly does that take place in the center?
Dr. Chance Mysayphonh: So in the center, normally, if they're dialyzing that day for the infusion, and we find out they're COVID positive, normally we dialyze them for the entire prescription for dialysis. Then we would administer the medication at the end of the IV dialysis session. That way, we can actually observe them while they're on just the medication itself, and there's no other issues with the infusion of the medication.
So after the hour of the infusion with the monoclonal antibodies, we would actually observe the patient for at least an extra hour to determine if everything went safely and effectively for that patient. And keep in mind, the therapies, and the time added to this infusion may be two hours after infusion, but this is a one-time infusion for our patients. And what I've been hearing from our other colleagues is this is something that people actually want to get, because it's something that can determine if they're hospitalized or not.
Brad Puffer: I know you've been studying closely the FDA studies, and what led up to the emergency use authorization. What have those studies told us about both the safety and efficacy of this therapy?
Dr. Chance Mysayphonh: They issued the EUA, saying these are the therapies that can make a difference in patient outcomes. So that's the reason why the EUA was issued. Because clinically, these patients would recover-- or the viral load seen in these infected patients were actually lower than the ones that did not receive the therapies. And a lot of these patients that did receive therapies did not end up being hospitalized because of it. So if you look at the study for bamlanivimab, about 1.6% of patients that received the product versus 6% that did not receive the product end up hospitalized or having an ER visit because of COVID-19.
In terms of safety, there's about 3% of people that do experience some kind of side effects. But these are more associated with a higher dose or rate of the infusion of the product itself. And some of these side effects were just fever, chills, and nausea and headaches, things like that. There was a case of hypersensitivity reaction that required the use of epinephrine. But we do have a policy and procedure in place that the person doing the monoclonal antibody infusion must be trained on our anaphylaxis protocol to be able to give the infusion.
Brad Puffer: Well, I know this is happening really fast. We really just launched this project at the start of 2021. What does the rollout look like to date in our centers? Have we had any success stories? And how quickly are we going to be able to get this therapy to our patients?
Dr. Chance Mysayphonh: So we are in a process of distributing antibodies to our COVID-19 isolation clinics. And we do require that our staff participate in our live training events before we can distribute the product. So we have successfully deployed a program to our pilot sites, per se, in Alaska and Nebraska, before the nationwide rollout. But right now, it's a little too early to tell how successful we are. But we will be collecting various clinical data associated with the use of the monoclonal antibodies.
Brad Puffer: So we'll be following our success very closely. I know that something that we're very focused on is research, and being able to deliver some details about how well this therapy has done for our patients. And I'm sure the FDA will be interested in that as well.
Dr. Chance Mysayphonh: That's correct. I mean, we are working hand in hand with both the FDA and Health and Human Services. Because they do want this for our outpatient clinic settings. Because they have seen great signals in the non-outpatient settings-- the challenges you alluded to earlier-- they're not able to do it effectively in the hospital settings.
Brad Puffer: Well, it sounds like it's been a really big team project in order to get all the pieces together to get this therapy to our patients. It must be really exciting.
Dr. Chance Mysayphonh: This is something that we have for our patients that can determine if they end up hospitalized or not. So our patient population are at one of the higher risks for severe COVID-19 disease once they get infected with COVID-19.
Brad Puffer: It's been wonderful discussing this with you, Dr. Mysayphonh. Thank you so much for giving us some great insight into our efforts to safely use this antibody therapy to ensure the health of our patients and staff. It's great to know that we have people like you working on this important project, so thank you for joining us.
Dr. Chance Mysayphonh: Yeah, thank you, Brad. Thank you for having me on.
Brad Puffer: And to our audience, thank you also for joining us. Don't forget, you can find Field Notes on the Apple Store or Google Play, or right here at fmcna.com, where you can also find our annual medical report and other featured articles. We hope you'll come back and join us, as we have many more topics to discuss in the weeks ahead. Until next time, I'm Brad Puffer, and you've been listening to Field Notes by Fresenius Medical Care. Take care, everyone.