Recent promotion by several countries, including the United States, of hydroxychloroquine as an effective treatment for COVID-19 has left patients with systemic lupus erythematosus (lupus) facing a severe shortage of the medication they rely on. How should rheumatologists balance the supply of hydroxychloroquine for testing and potential use in COVID-19 with its critical use in the treatment of lupus? How should they allocate the drug to their patients?
Rosalind Ramsey-Goldman, MD, discusses key considerations for rheumatologists in the context of the COVID-19 pandemic, including the risks for patients with rheumatic conditions such as lupus and how Northwestern Medicine Rheumatology is evolving care.
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Balancing Hydroxychloroquine Use for COVID-19 and Lupus
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Learn more about Rosalind Ramsey-Goldman, MD
Rosalind Ramsey-Goldman, MD
Rosalind Ramsey-Goldman, MD Focus of Work includes epidemiology of systemic lupus erythematosus, pregnancy and rheumatic diseases, osteoporosis, steroid-induced osteoporosis, clinical drug trials in lupus.Learn more about Rosalind Ramsey-Goldman, MD
Transcription:
Balancing Hydroxychloroquine Use for COVID-19 and Lupus
Melanie Cole (Host): This is the Northwestern Medicine Podcast on COVID-19 dated March 30, 2020.
Welcome. This is Better Edge, a Northwestern Medicine podcast for physicians. I’m Melanie Cole and joining me today is Dr. Rosalind Ramsey-Goldman. She is the Solvay Arthritis Research Society Research Professor and a Professor of Medicine in the Division of Rheumatology at Northwestern Medicine. Today we’re talking about COVID-19 and the risk for patients with rheumatic conditions, the use of hydroxychloroquine for treatment and how Northwestern Medicine is evolving care during this pandemic. Thank you, Dr. Ramsey-Goldman, so much for joining us today. In these unprecedented times, let’s start by talking about the risk of COVID-19 to patients with rheumatic conditions such as lupus. I assume that they are at greater risk since they are immunocompromised?
Rosalind Ramsey-Goldman, MD (Guest): According to the CDC, the high risk groups for COVID-19 infection include those individuals 65 years of age and older, persons living in nursing homes or long term care facilities and those individuals with comorbid conditions including patients who are immunocompromised, and this would include patients with autoimmune disorders such as lupus.
Host: Dr. Ramsey-Goldman, should these patients continue taking their medication or delay treatment? Why is this so important that they continue to take their medications as prescribed?
Dr. Ramsey-Goldman: Rheumatologists are recommending that lupus patients continue to take their medications because if their disease is controlled, we want to keep it that way and keep them out of the hospital. If the disease flares, we may need to use more medication on top of an immune system that’s going in overdrive that is part of that flare. This later situation may place the immunocompromised patients such as someone with lupus at further risk for infection and possibly even getting a more severe infection. If a patient has questions about how to manage their medications, they should call their rheumatologist for further guidance. I want to emphasize that hydroxychloroquine is an essential medication for patients with lupus.
It is also mainstay of therapy for many patients with rheumatoid arthritis. Especially in the case of a lupus patient who is pregnant, hydroxychloroquine is the cornerstone of therapy. For all lupus patients, it’s used unless there is a clear contraindication. It is the only medication shown to increase survival in lupus patients and it’s also been shown to reduce lupus flares and prevent organ damage including cardiovascular events. Withdrawal of hydroxychloroquine from patients with lupus for even an interval as short as two weeks, can result in a flare even if they’ve had previously clinical stable disease.
Host: Well that makes really good sense. So, then what extra precautions are you advising them to take to protect themselves at this time?
Dr. Ramsey-Goldman: Well in addition to the recommendations from the CDC and the local public health organizations, the extra precautions we are advising the patients are if you are exposed or actually have any respiratory symptoms that are concerning; that you call your doctor or the local hotline for your healthcare facility where you can get answers to your questions and get assistance with next steps. We would also advise avoiding any activity that might worsen a heart or lung problem which is one of the comorbid conditions that increases the risk for infection or severity infection. An example of an activity such as this is smoking. This would be a great time to quit smoking and if you have quit in the past, try not to go back to smoking even though it might be tempting when you are stressed. And work with your healthcare provider to help with wellness strategies.
We get many calls concerning what to do about ongoing care, how to manage your medications, they are having difficulty getting medications, how to get their medicines safely without additional exposure and even help with navigating their workplace and questions that might be raised due to their higher risk for lupus. We are here to help all patients navigate these difficult questions during this crisis. It’s important to continue self-care and we have resources available for wellness, stress management, how to keep in touch at a safe distance and hotlines for emotional emergencies.
Host: That’s very calming Dr. Ramsey-Goldman and thank you for that answer. For those with lupus, or other rheumatic conditions that show symptoms or are actually diagnosed with COVID-19, when are you recommending admission to the hospital?
Dr. Ramsey-Goldman: Physicians are working with patients by asking questions concerning their symptoms that might lead to a recommendation for hospitalization. We know as physicians, that most individuals who get COVID-19 will have mild to moderate illnesses and this status would not require hospitalization. When we talk with patients, or our hotline talks to patients; we will ask them a series of questions to determine if they need additional testing or if they should go to the emergency room for likely admission. If they are monitored at home, we will be calling them to assess their status and then revise our recommendations accordingly. Patients can also talk with their rheumatologist through Telehealth and if those symptoms are concerning then the rheumatologist will refer that patient to the hotline for further screening.
Host: Well thank you so much. So how are you and your team evolving care for your patients during this pandemic? Talk specifically about how you’re utilizing and optimizing Telehealth. You just mentioned it, so tell us a little bit about how the process works.
Dr. Ramsey-Goldman: Well first of all, for patients who must get their medications on site, patients are very concerned about coming to the facility to receive their much needed treatment. We prescreen everybody by phone and then also at the time that they show up for their visit to assess their current risk and if they say no to all of the screening questions, then they can have their infusion in our office suite. We are following all safety precautions to protect our patients and our healthcare providers. We adjust the time between the infusion visits so that we have fewer patients on site for the safety of all. And if someone has symptoms, we have procedures in place for everyone’s safety when disposition is determined.
We call our hotline for further direction. Now regarding Telehealth, if we don’t have to see the patient in person, we subscribe to this new procedure where we review everyone on the clinic schedule and offer a Telemedicine visit. If they happen to come to the clinic and they are not coming for required inpatient treatment, we advise them to go home and offer a Telemedicine visit. All patients have been very appreciative of our mutual concern to protect them and us during this crisis. And I have to say, all of my colleagues have learned very quickly how to do Telemedicine visits.
Host: Well what would you like to tell other rheumatologists that are implementing Telemedicine from what you’ve learned?
Dr. Ramsey-Goldman: We have resources from our professional organization, the American College of Rheumatology at all of these resources are available online. Also our hospital and I’m sure many other hospitals and clinics have instructions that apply specifically to your place of work. And we also have support to help with technical issues, how to document appropriately and how to strategize management for follow up care.
Host: So, now Dr. Ramsey-Goldman there have been recent claims from several countries including the United States that hydroxychloroquine may be used to treat COVID-19. Are there any studies to support this and what did those studies show? Is it safe and effective treatment for COVID? What do we know as of now?
Dr. Ramsey-Goldman: Well according to the CDC guidelines, there are no US Food and Drug Administration or FDA approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures and supportive care including supplemental oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigative drugs are being studied in several hundred clinical trials that are underway across the globe. The CDC, the American College of Rheumatology and the FDA are providing guidance for the treatment of COVID-19 with hydroxychloroquine or a related medication called chloroquine because these medicines as well as other agents have demonstrated antiviral activity against SARS, COVI-2 in tissue cultures. These findings as well as relative tolerability of hydroxychloroquine in patients taking the drug for FDA approved indications has raised interest in these agents as potential therapeutic options in the current COVID-19 pandemic.
A high profile report from France described using hydroxychloroquine alone and also in combination with an antibiotic called azithromycin in patients with COVID-19 and this study was made public in March of this year. Both of these drugs were then subsequently publicized as therapeutic options for patients with COVID-19. There are serious flaws in the methodology interpretation of this data even though it was quickly publicized. At this time, no currently available data from randomized clinical trials to inform guidance on the use, dosage and duration of hydroxychloroquine either for treatment or prophylaxis of the infection. Having said that, hydroxychloroquine in under investigation in clinical trials for preexposure or postexposure prophylaxis of the SARS, COVI-2 infection or COVID-19 and also for treatment of patients with mild, moderate and severe COVID-19 infection.
In the United States, there are trials going on with these drugs and more information on these trials can be found at www.clinicaltrials.gov website. Because this medication hydroxychloroquine is being considered for treatment for the infection, there are shortages of this drug as there are relatively few regular manufacturers and we have a history of shortages and price spikes for this medication in the United States. The FDA just yesterday issued an emergency use authorization for hydroxychloroquine and chloroquine allowing the drugs to be donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19 as appropriate even if a clinical trial might not be available or feasible at that site. Therefore, we have to balance the resource allocation between those patients who need these medications for their approve FDA indication management of their underlying disease while still working towards the needs of the community as a whole in terms of getting a treatment that might work in the current pandemic.
Host: Wow it’s such an interesting topic. Dr. Ramsey-Goldman so based on everything you’re saying, and the studies and the recommendations that are coming out; as a result of the recent promotion, and the high demand that you just discussed; what are you advising patients to do and what advice do you have for other rheumatologists about the use of hydroxychloroquine for their patients?
Dr. Ramsey-Goldman: We are advising our patients to talk to their providers concerning access to the medication, any possible dosage change and if there are alternative medications. Lupus patients require ongoing management and the person who knows the best way to care for them is their personal physician. So, we encourage the patients to talk to their physicians to get a plan and an alternative plan should there be a shortage.
We don’t know if lupus patients might even be more protected from the virus taking this medication, but I can tell you that the international rheumatology community has organized a registry to collect information on patients with rheumatic diseases and the COVID-19 infection so that we can better inform our colleagues as well as our patients moving forward as this situation develops. There are also local groups that are developing surveillance strategies to also understand the risks of infection.
Host: And Doctor, before we wrap up, we know the potential negative side effects of hydroxychloroquine but since the drug has shown some benefit; would you recommend it for the critically ill with COVID-19? What are your recommendations for the allocation of the drug during this pandemic? You spoke about it a little bit, but as we’re concluding, how should rheumatologists balance the supply for possible use and testing with it’s known and critical use in the treatment of lupus?
Dr. Ramsey-Goldman: We certainly understand the concern across the individual patient as well as for society and based on the principles that the American College of Rheumatology and other rheumatology professional and patient organizations; have issued statements providing guidance and what we are suggesting is that we highlight as advocates for our patients, the need for critical access to hydroxychloroquine for our patients but we also ask the policy makers to work together with us and the patient communities to ensure the availability of these drugs for all who might need them. I think that the important place is to use hydroxychloroquine in the setting of the current COVID-19 infection in a controlled setting and for our hospital at Northwestern Medicine, it does have a place in the plan for treatment of patients who are hospitalized for the infection and it includes critically ill patients, hospitalized patients or those who have risk factors and all of this is done under the supervision of a physician to monitor the dosing and to monitor for side effects so that it can be done safely.
If a rheumatologist has a facility that has access to a clinical trial, I think that this would also be an ideal place to provide this medication for the infection so that not only do we ensure the safety of the individual who is receiving the medication but also that we learn how to use it so that we can refine our recommendations moving forward.
Host: Thank you Dr. Ramsey-Goldman for joining us. What important information for other physicians to hear. Thank you so much. And that wraps up this episode of Better Edge, a Northwestern Medicine podcast for physicians. To refer your patient or for more information on COVID-19 please visit our website at www.nm.org to get connected with one of our providers. Please remember to subscribe, rate and review this podcast and all the other Northwestern Medicine podcasts. I’m Melanie Cole.
Balancing Hydroxychloroquine Use for COVID-19 and Lupus
Melanie Cole (Host): This is the Northwestern Medicine Podcast on COVID-19 dated March 30, 2020.
Welcome. This is Better Edge, a Northwestern Medicine podcast for physicians. I’m Melanie Cole and joining me today is Dr. Rosalind Ramsey-Goldman. She is the Solvay Arthritis Research Society Research Professor and a Professor of Medicine in the Division of Rheumatology at Northwestern Medicine. Today we’re talking about COVID-19 and the risk for patients with rheumatic conditions, the use of hydroxychloroquine for treatment and how Northwestern Medicine is evolving care during this pandemic. Thank you, Dr. Ramsey-Goldman, so much for joining us today. In these unprecedented times, let’s start by talking about the risk of COVID-19 to patients with rheumatic conditions such as lupus. I assume that they are at greater risk since they are immunocompromised?
Rosalind Ramsey-Goldman, MD (Guest): According to the CDC, the high risk groups for COVID-19 infection include those individuals 65 years of age and older, persons living in nursing homes or long term care facilities and those individuals with comorbid conditions including patients who are immunocompromised, and this would include patients with autoimmune disorders such as lupus.
Host: Dr. Ramsey-Goldman, should these patients continue taking their medication or delay treatment? Why is this so important that they continue to take their medications as prescribed?
Dr. Ramsey-Goldman: Rheumatologists are recommending that lupus patients continue to take their medications because if their disease is controlled, we want to keep it that way and keep them out of the hospital. If the disease flares, we may need to use more medication on top of an immune system that’s going in overdrive that is part of that flare. This later situation may place the immunocompromised patients such as someone with lupus at further risk for infection and possibly even getting a more severe infection. If a patient has questions about how to manage their medications, they should call their rheumatologist for further guidance. I want to emphasize that hydroxychloroquine is an essential medication for patients with lupus.
It is also mainstay of therapy for many patients with rheumatoid arthritis. Especially in the case of a lupus patient who is pregnant, hydroxychloroquine is the cornerstone of therapy. For all lupus patients, it’s used unless there is a clear contraindication. It is the only medication shown to increase survival in lupus patients and it’s also been shown to reduce lupus flares and prevent organ damage including cardiovascular events. Withdrawal of hydroxychloroquine from patients with lupus for even an interval as short as two weeks, can result in a flare even if they’ve had previously clinical stable disease.
Host: Well that makes really good sense. So, then what extra precautions are you advising them to take to protect themselves at this time?
Dr. Ramsey-Goldman: Well in addition to the recommendations from the CDC and the local public health organizations, the extra precautions we are advising the patients are if you are exposed or actually have any respiratory symptoms that are concerning; that you call your doctor or the local hotline for your healthcare facility where you can get answers to your questions and get assistance with next steps. We would also advise avoiding any activity that might worsen a heart or lung problem which is one of the comorbid conditions that increases the risk for infection or severity infection. An example of an activity such as this is smoking. This would be a great time to quit smoking and if you have quit in the past, try not to go back to smoking even though it might be tempting when you are stressed. And work with your healthcare provider to help with wellness strategies.
We get many calls concerning what to do about ongoing care, how to manage your medications, they are having difficulty getting medications, how to get their medicines safely without additional exposure and even help with navigating their workplace and questions that might be raised due to their higher risk for lupus. We are here to help all patients navigate these difficult questions during this crisis. It’s important to continue self-care and we have resources available for wellness, stress management, how to keep in touch at a safe distance and hotlines for emotional emergencies.
Host: That’s very calming Dr. Ramsey-Goldman and thank you for that answer. For those with lupus, or other rheumatic conditions that show symptoms or are actually diagnosed with COVID-19, when are you recommending admission to the hospital?
Dr. Ramsey-Goldman: Physicians are working with patients by asking questions concerning their symptoms that might lead to a recommendation for hospitalization. We know as physicians, that most individuals who get COVID-19 will have mild to moderate illnesses and this status would not require hospitalization. When we talk with patients, or our hotline talks to patients; we will ask them a series of questions to determine if they need additional testing or if they should go to the emergency room for likely admission. If they are monitored at home, we will be calling them to assess their status and then revise our recommendations accordingly. Patients can also talk with their rheumatologist through Telehealth and if those symptoms are concerning then the rheumatologist will refer that patient to the hotline for further screening.
Host: Well thank you so much. So how are you and your team evolving care for your patients during this pandemic? Talk specifically about how you’re utilizing and optimizing Telehealth. You just mentioned it, so tell us a little bit about how the process works.
Dr. Ramsey-Goldman: Well first of all, for patients who must get their medications on site, patients are very concerned about coming to the facility to receive their much needed treatment. We prescreen everybody by phone and then also at the time that they show up for their visit to assess their current risk and if they say no to all of the screening questions, then they can have their infusion in our office suite. We are following all safety precautions to protect our patients and our healthcare providers. We adjust the time between the infusion visits so that we have fewer patients on site for the safety of all. And if someone has symptoms, we have procedures in place for everyone’s safety when disposition is determined.
We call our hotline for further direction. Now regarding Telehealth, if we don’t have to see the patient in person, we subscribe to this new procedure where we review everyone on the clinic schedule and offer a Telemedicine visit. If they happen to come to the clinic and they are not coming for required inpatient treatment, we advise them to go home and offer a Telemedicine visit. All patients have been very appreciative of our mutual concern to protect them and us during this crisis. And I have to say, all of my colleagues have learned very quickly how to do Telemedicine visits.
Host: Well what would you like to tell other rheumatologists that are implementing Telemedicine from what you’ve learned?
Dr. Ramsey-Goldman: We have resources from our professional organization, the American College of Rheumatology at all of these resources are available online. Also our hospital and I’m sure many other hospitals and clinics have instructions that apply specifically to your place of work. And we also have support to help with technical issues, how to document appropriately and how to strategize management for follow up care.
Host: So, now Dr. Ramsey-Goldman there have been recent claims from several countries including the United States that hydroxychloroquine may be used to treat COVID-19. Are there any studies to support this and what did those studies show? Is it safe and effective treatment for COVID? What do we know as of now?
Dr. Ramsey-Goldman: Well according to the CDC guidelines, there are no US Food and Drug Administration or FDA approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures and supportive care including supplemental oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigative drugs are being studied in several hundred clinical trials that are underway across the globe. The CDC, the American College of Rheumatology and the FDA are providing guidance for the treatment of COVID-19 with hydroxychloroquine or a related medication called chloroquine because these medicines as well as other agents have demonstrated antiviral activity against SARS, COVI-2 in tissue cultures. These findings as well as relative tolerability of hydroxychloroquine in patients taking the drug for FDA approved indications has raised interest in these agents as potential therapeutic options in the current COVID-19 pandemic.
A high profile report from France described using hydroxychloroquine alone and also in combination with an antibiotic called azithromycin in patients with COVID-19 and this study was made public in March of this year. Both of these drugs were then subsequently publicized as therapeutic options for patients with COVID-19. There are serious flaws in the methodology interpretation of this data even though it was quickly publicized. At this time, no currently available data from randomized clinical trials to inform guidance on the use, dosage and duration of hydroxychloroquine either for treatment or prophylaxis of the infection. Having said that, hydroxychloroquine in under investigation in clinical trials for preexposure or postexposure prophylaxis of the SARS, COVI-2 infection or COVID-19 and also for treatment of patients with mild, moderate and severe COVID-19 infection.
In the United States, there are trials going on with these drugs and more information on these trials can be found at www.clinicaltrials.gov website. Because this medication hydroxychloroquine is being considered for treatment for the infection, there are shortages of this drug as there are relatively few regular manufacturers and we have a history of shortages and price spikes for this medication in the United States. The FDA just yesterday issued an emergency use authorization for hydroxychloroquine and chloroquine allowing the drugs to be donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19 as appropriate even if a clinical trial might not be available or feasible at that site. Therefore, we have to balance the resource allocation between those patients who need these medications for their approve FDA indication management of their underlying disease while still working towards the needs of the community as a whole in terms of getting a treatment that might work in the current pandemic.
Host: Wow it’s such an interesting topic. Dr. Ramsey-Goldman so based on everything you’re saying, and the studies and the recommendations that are coming out; as a result of the recent promotion, and the high demand that you just discussed; what are you advising patients to do and what advice do you have for other rheumatologists about the use of hydroxychloroquine for their patients?
Dr. Ramsey-Goldman: We are advising our patients to talk to their providers concerning access to the medication, any possible dosage change and if there are alternative medications. Lupus patients require ongoing management and the person who knows the best way to care for them is their personal physician. So, we encourage the patients to talk to their physicians to get a plan and an alternative plan should there be a shortage.
We don’t know if lupus patients might even be more protected from the virus taking this medication, but I can tell you that the international rheumatology community has organized a registry to collect information on patients with rheumatic diseases and the COVID-19 infection so that we can better inform our colleagues as well as our patients moving forward as this situation develops. There are also local groups that are developing surveillance strategies to also understand the risks of infection.
Host: And Doctor, before we wrap up, we know the potential negative side effects of hydroxychloroquine but since the drug has shown some benefit; would you recommend it for the critically ill with COVID-19? What are your recommendations for the allocation of the drug during this pandemic? You spoke about it a little bit, but as we’re concluding, how should rheumatologists balance the supply for possible use and testing with it’s known and critical use in the treatment of lupus?
Dr. Ramsey-Goldman: We certainly understand the concern across the individual patient as well as for society and based on the principles that the American College of Rheumatology and other rheumatology professional and patient organizations; have issued statements providing guidance and what we are suggesting is that we highlight as advocates for our patients, the need for critical access to hydroxychloroquine for our patients but we also ask the policy makers to work together with us and the patient communities to ensure the availability of these drugs for all who might need them. I think that the important place is to use hydroxychloroquine in the setting of the current COVID-19 infection in a controlled setting and for our hospital at Northwestern Medicine, it does have a place in the plan for treatment of patients who are hospitalized for the infection and it includes critically ill patients, hospitalized patients or those who have risk factors and all of this is done under the supervision of a physician to monitor the dosing and to monitor for side effects so that it can be done safely.
If a rheumatologist has a facility that has access to a clinical trial, I think that this would also be an ideal place to provide this medication for the infection so that not only do we ensure the safety of the individual who is receiving the medication but also that we learn how to use it so that we can refine our recommendations moving forward.
Host: Thank you Dr. Ramsey-Goldman for joining us. What important information for other physicians to hear. Thank you so much. And that wraps up this episode of Better Edge, a Northwestern Medicine podcast for physicians. To refer your patient or for more information on COVID-19 please visit our website at www.nm.org to get connected with one of our providers. Please remember to subscribe, rate and review this podcast and all the other Northwestern Medicine podcasts. I’m Melanie Cole.